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| ID | Type | Description | Link |
|---|---|---|---|
| U01NS104157 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| Mayo Clinic | OTHER |
| Johns Hopkins University | OTHER |
| University of California, San Francisco | OTHER |
| National Institute of Neurological Disorders and Stroke (NINDS) |
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Brain Cavernous Angiomas with Symptomatic Hemorrhage (CASH) are rare, but they exact a heavy burden of neurologic disability from recurrent bleeding, for which there is no proven therapy. This trial readiness project aims to address current critical obstacles in identifying cases at multiple sites, characterizing their relevant features, and measuring their outcome. The timing cannot be more opportune, with therapeutic targets already identified, exceptional collaboration among researchers and with the patient community, and several drugs ready to benefit from a track to clinical testing in the next five years.
The Trial Readiness grant mechanism, funded by NINDS, proposes to address knowledge gaps and establish a research network as infrastructure for future research. This project includes an observational cohort study of 181 patients with an operational goal of demonstrating the feasibility of screening, enrollment rates, baseline disease categorization and follow-up of CASH using common data elements at multiple sites, and to assess the following endpoints for 123 participants enrolled at centers prespecified to do prospective follow-up: (1) the rates of recurrent hemorrhage; (2) the reliability of imaging biomarkers including quantitative susceptibility mapping and permeability measures which have been shown to correlate with lesion activity, and (3) change in functional status during prospective follow-up.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| CASH (Cavernous Angiomas with Symptomatic Hemorrhage) | The adjudicated definition of CASH (Cavernous Angiomas with Symptomatic Hemorrhage) requires diagnostic evidence of new lesional bleeding or hemorrhagic growth, in association with directly attributable symptoms. |
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| Measure | Description | Time Frame |
|---|---|---|
| Rate of Recurrent Symptomatic Hemorrhage During the Two Year Follow-up Period in Patients With CASH. | Number of new bleeds reported during the two year follow-up period in the cohort with CASH. We will assess the change in the number of new symptomatic hemorrhage from baseline to year 1 and year 1 to year 2 follow-up. | 2 year |
| Measure | Description | Time Frame |
|---|---|---|
| Percent Change in QSM Value (Lesional Iron Content) | Change in QSM value (lesional iron content) will be presented as a mean value across all participants from baseline to year 1 and year 1 to year 2 follow-up MRIs | 2 years of follow-up |
| Percent Change in Contrast-enhanced Quantitative Perfusion (DCEQP) Value (Vascular Permeability) |
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Inclusion Criteria
Exclusion Criteria
To be eligible for Aims 2 and 3, CASH cases enrolled in Aim 1 will be further excluded from follow-up and baseline validation (FUBV) for the following reasons:
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Patients with Brain Cavernous Angiomas with Symptomatic Hemmhorage (CASH) that have occurred within the last year.
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| Name | Affiliation | Role |
|---|---|---|
| Issam A Awad, MD | University of Chicago | Principal Investigator |
| Daniel Hanley, MD | Johns Hopkins University | Principal Investigator |
| Kelly Flemming, MD | Mayo Clinic | Principal Investigator |
| Helen Kim, MPH, PhD | University of California, San Francisco | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| The University of Chicago Medical Center | Chicago | Illinois | 60637 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 40614265 | Derived | Kinkade S, Li H, Hage S, Koskimaki J, Stadnik A, Lee J, Shenkar R, Papaioannou J, Flemming KD, Kim H, Torbey M, Huang J, Carroll TJ, Girard R, Giger ML, Awad IA. Identifying features of prior hemorrhage in cerebral cavernous malformations on quantitative susceptibility maps: a machine learning pilot study. J Neurosurg. 2025 Jul 4;143(6):1567-1574. doi: 10.3171/2025.3.JNS243051. Print 2025 Dec 1. | |
| 38134268 | Derived | Flemming KD, Kim H, Hage S, Mandrekar J, Kinkade S, Girard R, Torbey M, Huang J, Huston J 3rd, Shu Y, Lanzino G, Selwyn R, Hart B, Mabray M, Feghali J, Sair HI, Narvid J, Lupo JM, Lee J, Stadnik A, Alcazar-Felix RJ, Shenkar R, Lane K, McBee N, Treine K, Ostapkovich N, Wang Y, Thompson R, Koenig JI, Carroll T, Hanley D, Awad I. Trial Readiness of Cavernous Malformations With Symptomatic Hemorrhage, Part I: Event Rates and Clinical Outcome. Stroke. 2024 Jan;55(1):22-30. doi: 10.1161/STROKEAHA.123.044068. Epub 2023 Dec 22. |
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Study Protocol has been published in Neurosurgery
Protocol paper was published November 2018 in Neurosurgery
can be accessed through Neurosurgery or Pubmed. Primary study contacts can also provide a copy upon request.
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123 participants were enrolled and followed up for 2 years and all results are provided only for these participants.
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| ID | Title | Description |
|---|---|---|
| FG000 | CASH (Cavernous Angiomas With Symptomatic Hemorrhage) | The adjudicated definition of CASH (Cavernous Angiomas with Symptomatic Hemorrhage) requires diagnostic evidence of new lesional bleeding or hemorrhagic growth, in association with directly attributable symptoms. |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
Baseline characteristics will be provided for only those participants who had follow-up.
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| ID | Title | Description |
|---|---|---|
| BG000 | CASH (Cavernous Angiomas With Symptomatic Hemorrhage) | The adjudicated definition of CASH (Cavernous Angiomas with Symptomatic Hemorrhage) requires diagnostic evidence of new lesional bleeding or hemorrhagic growth, in association with directly attributable symptoms. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Rate of Recurrent Symptomatic Hemorrhage During the Two Year Follow-up Period in Patients With CASH. | Number of new bleeds reported during the two year follow-up period in the cohort with CASH. We will assess the change in the number of new symptomatic hemorrhage from baseline to year 1 and year 1 to year 2 follow-up. | Posted | Number | Number of new bleeds | 2 year |
|
Adverse events were not assessed for this study since it is an observational study for trial readiness.
Adverse events were not assessed for this study since it is an observational study for trial readiness.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | CASH (Cavernous Angiomas With Symptomatic Hemorrhage) | The adjudicated definition of CASH (Cavernous Angiomas with Symptomatic Hemorrhage) requires diagnostic evidence of new lesional bleeding or hemorrhagic growth, in association with directly attributable symptoms. |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Agnieszka Stadnik | University of Chicago, Medicine and Biological Sciences Division | (773) 702-8996 | astadnik@bsd.uchicago.edu |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Nov 13, 2020 | May 8, 2024 | Prot_SAP_000.pdf |
| ICF | No | No | Yes | Informed Consent Form | May 21, 2021 | Mar 26, 2024 | ICF_001.pdf |
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| ID | Term |
|---|---|
| D018324 | Hemangioma, Capillary |
| D020786 | Hemangioma, Cavernous, Central Nervous System |
| C566394 | Cerebral Cavernous Malformations 2 |
| C566393 | Cerebral Cavernous Malformations 3 |
| D006392 | Hemangioma, Cavernous |
| ID | Term |
|---|---|
| D006391 | Hemangioma |
| D009383 | Neoplasms, Vascular Tissue |
| D009370 | Neoplasms by Histologic Type |
| D009369 | Neoplasms |
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| NIH |
| University of Utah | OTHER |
| University of New Mexico | OTHER |
| Barrow Neurological Institute | OTHER |
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Change in DCEQP value (vascular permeability) will be presented as a mean value across all participants from baseline to year 1 and year 1 to year 2 follow-up MRIs |
| 2 years of follow-up |
| Compare the Number of Patients With MRS 2 or Higher Who Had Prospective Symptomatic Hemorrhage to Those With MRS 2 or Higher Without Prospective Symptomatic Hemorrhage During the 2 Year Follow-up Period. | Compare the number of patients with MRS 2 or higher who had prospective symptomatic hemorrhage to those with MRS 2 or higher without prospective symptomatic hemorrhage from baseline to year 1 and year 1 to year 2 follow-up periods. The mRS is a simple global measure of functional disability. Scores range from 0 (no symptoms) to 6 (death). An mRS score of 0 to 1 is considered a minimal clinical disability, and 0 to 2 is independent. | 2 years of follow-up |
| Percentage of Patients With National Institutes of Health Stroke Scale (NIHSS) 0-4, 5-14 and 14+ During the 2 Year Follow-up Period. | Percentage of patients with National Institutes of Health Stroke Scale (NIHSS) 0-4, 5-14 and 14+ from baseline to year 1 and year 1 to year 2 follow-up periods. NIHSS values range from 0 to 42, with stroke severity categorized as mild (0 to 4), moderate (5 to 14), severe (15 to 24), and very severe (≥25). 4-point decline in ischemic stroke clinical trials typically measures functional decline. | 2 years of follow-up |
| Median Score of European Quality of Life Visual Analogue Scale (EQ-VAS) During the 2 Year Follow-up Period. | Median score of European Quality of Life Visual Analogue Scale (EQ-VAS) at baseline, year 1, year 2. The EQ-VAS is a vertical visual analogue scale that takes values between 100 (best imaginable health) and 0 (worst imaginable health), on which patients provide a global assessment of their health. | 2 years of follow-up |
| Proportion of Patients With No Problems, Mild Problems, or Severe Problems in the "Mobility" Domain of European Quality of Life 5 Dimensions 3 Level Version (EQ-5D-3 L) During the 2 Year Follow-up Period. | Proportion of patients with no problems, mild problems, or severe problems in the "Mobility" domain of EQ-5D-3 L will be assessed at baseline, year 1, and year 2 follow-up periods. EQ-5D-3 L is a generic tool for Patient Reported Outcomes (PRO) measurement that can assess patients' quality of life, irrespective of the disease and includes 5 domains: mobility, self-care, usual activities, pain/discomfort, and anxiety/depression. There are 3 questions per domain where patients respond if they have no problems, mild, or severe problems. | 2 years of follow-up |
| Proportion of Patients With No Problems, Mild Problems, or Severe Problems in the "Self-care" Domain of European Quality of Life 5 Dimensions 3 Level Version (EQ-5D-3 L) During the 2 Year Follow-up Period. | Proportion of patients with no problems, mild problems, or severe problems in the "Self-care" domain of EQ-5D-3 L will be assessed at baseline, year 1, and year 2 follow-up periods. EQ-5D-3 L is a generic tool for Patient Reported Outcomes (PRO) measurement that can assess patients' quality of life, irrespective of the disease and includes 5 domains: mobility, self-care, usual activities, pain/discomfort, and anxiety/depression. There are 3 questions per domain where patients respond if they have no problems, mild, or severe problems. | 2 years of follow-up |
| Proportion of Patients With No Problems, Mild Problems, or Severe Problems in the "Usual Activities" Domain of European Quality of Life 5 Dimensions 3 Level Version (EQ-5D-3 L) During the 2 Year Follow-up Period. | Proportion of patients with no problems, mild problems, or severe problems in the "Usual activities" domain of EQ-5D-3 L will be assessed at baseline, year 1, and year 2 follow-up periods. EQ-5D-3 L is a generic tool for Patient Reported Outcomes (PRO) measurement that can assess patients' quality of life, irrespective of the disease and includes 5 domains: mobility, self-care, usual activities, pain/discomfort, and anxiety/depression. There are 3 questions per domain where patients respond if they have no problems, mild, or severe problems. | 2 years of follow-up |
| Proportion of Patients With No Problems, Mild Problems, or Severe Problems in the "Pain / Discomfort" Domain of European Quality of Life 5 Dimensions 3 Level Version (EQ-5D-3 L) During the 2 Year Follow-up Period. | Proportion of patients with no problems, mild problems, or severe problems in the "Pain / Discomfort" domain of EQ-5D-3 L will be assessed at baseline, year 1, and year 2 follow-up periods. EQ-5D-3 L is a generic tool for Patient Reported Outcomes (PRO) measurement that can assess patients' quality of life, irrespective of the disease and includes 5 domains: mobility, self-care, usual activities, pain/discomfort, and anxiety/depression. There are 3 questions per domain where patients respond if they have no problems, mild, or severe problems. | 2 years of follow-up |
| Proportion of Patients With No Problems, Mild Problems, or Severe Problems in the "Anxiety / Depression" Domain of European Quality of Life 5 Dimensions 3 Level Version (EQ-5D-3 L) During the 2 Year Follow-up Period. | Proportion of patients with no problems, mild problems, or severe problems in the "Anxiety / Depression" domain of EQ-5D-3 L will be assessed at baseline, year 1, and year 2 follow-up periods. EQ-5D-3 L is a generic tool for Patient Reported Outcomes (PRO) measurement that can assess patients' quality of life, irrespective of the disease and includes 5 domains: mobility, self-care, usual activities, pain/discomfort, and anxiety/depression. There are 3 questions per domain where patients respond if they have no problems, mild, or severe problems. | 2 years of follow-up |
| Median T-score for "Anxiety" Domain of Patient-Reported Outcome Measurement Information System (PROMIS-29) During the 2 Year Follow-up Period. | Median T-score for "Anxiety" domain of Patient-Reported Outcome Measurement Information System (PROMIS-29) at baseline, year 1 and year 2. PROMIS-29 (Version 2.0) is a generic health-related quality of life measure including 7 domains (depression, anxiety, physical function, pain interference, fatigue, sleep disturbance, and ability to participate in social roles and activities).12 Each domain contains questions ranked using a 5-point Likert scale. PROMIS-29 domain scores are converted to T scores and have been standardized to a reference population (mean, 50; SD, 10). Clinically meaningful change is considered to be at least half the SD (5 points). Higher T-score indicates better outcome. | 2 years of follow-up |
| Median T-score for "Depression" Domain of Patient-Reported Outcome Measurement Information System (PROMIS-29) During the 2 Year Follow-up Period. | Median T-score for "Depression" domain of Patient-Reported Outcome Measurement Information System (PROMIS-29) at baseline, year 1, and year 2. PROMIS-29 (Version 2.0) is a generic health-related quality of life measure including 7 domains (depression, anxiety, physical function, pain interference, fatigue, sleep disturbance, and ability to participate in social roles and activities).12 Each domain contains questions ranked using a 5-point Likert scale. PROMIS-29 domain scores are converted to T scores and have been standardized to a reference population (mean, 50; SD, 10). Clinically meaningful change is considered to be at least half the SD (5 points). Higher T-score indicates better outcome. | 2 years of follow-up |
| Median T-score for "Fatigue" Domain of Patient-Reported Outcome Measurement Information System (PROMIS-29) During the 2 Year Follow-up Period. | Median T-score for "Fatigue" domain of Patient-Reported Outcome Measurement Information System (PROMIS-29) at baseline, year 1, and year 2. PROMIS-29 (Version 2.0) is a generic health-related quality of life measure including 7 domains (depression, anxiety, physical function, pain interference, fatigue, sleep disturbance, and ability to participate in social roles and activities).12 Each domain contains questions ranked using a 5-point Likert scale. PROMIS-29 domain scores are converted to T scores and have been standardized to a reference population (mean, 50; SD, 10). Clinically meaningful change is considered to be at least half the SD (5 points). Higher T-score indicates better outcome. | 2 years of follow-up |
| Median T-score for "Pain" Domain of Patient-Reported Outcome Measurement Information System (PROMIS-29) During the 2 Year Follow-up Period. | Median T-score for "Pain" domain of Patient-Reported Outcome Measurement Information System (PROMIS-29) at baseline, year 1 and year 2. PROMIS-29 (Version 2.0) is a generic health-related quality of life measure including 7 domains (depression, anxiety, physical function, pain interference, fatigue, sleep disturbance, and ability to participate in social roles and activities).12 Each domain contains questions ranked using a 5-point Likert scale. PROMIS-29 domain scores are converted to T scores and have been standardized to a reference population (mean, 50; SD, 10). Clinically meaningful change is considered to be at least half the SD (5 points). Higher T-score indicates better outcome. | 2 years of follow-up |
| Median T-score for "Sleep Disturbance" Domain of Patient-Reported Outcome Measurement Information System (PROMIS-29) During the 2 Year Follow-up Period. | Median T-score for "Sleep Disturbance" domain of Patient-Reported Outcome Measurement Information System (PROMIS-29) at baseline, year 1 and year 2. PROMIS-29 (Version 2.0) is a generic health-related quality of life measure including 7 domains (depression, anxiety, physical function, pain interference, fatigue, sleep disturbance, and ability to participate in social roles and activities).12 Each domain contains questions ranked using a 5-point Likert scale. PROMIS-29 domain scores are converted to T scores and have been standardized to a reference population (mean, 50; SD, 10). Clinically meaningful change is considered to be at least half the SD (5 points). Higher T-score indicates better outcome. | 2 years of follow-up |
| Median T-score for "Social" Domain of Patient-Reported Outcome Measurement Information System (PROMIS-29) During the 2 Year Follow-up Period. | Median T-score for "Social" domain of Patient-Reported Outcome Measurement Information System (PROMIS-29) at baseline, year 1 and year 2. PROMIS-29 (Version 2.0) is a generic health-related quality of life measure including 7 domains (anxiety, depression, fatigue, pain interference, sleep disturbance, and ability to participate in social roles and activities, and physical function).12 Each domain contains questions ranked using a 5-point Likert scale. PROMIS-29 domain scores are converted to T scores and have been standardized to a reference population (mean, 50; SD, 10). Clinically meaningful change is considered to be at least half the SD (5 points). Higher T-score indicates better outcome. | 2 years of follow-up |
| Median T-score for "Physical Function" Domain of Patient-Reported Outcome Measurement Information System (PROMIS-29) During the 2 Year Follow-up Period. | Median T-score for "Physical Function" domain of Patient-Reported Outcome Measurement Information System (PROMIS-29) at baseline, year 1 and year 2. PROMIS-29 (Version 2.0) is a generic health-related quality of life measure including 7 domains (anxiety, depression, fatigue, pain interference, sleep disturbance, and ability to participate in social roles and activities, and physical function).12 Each domain contains questions ranked using a 5-point Likert scale. PROMIS-29 domain scores are converted to T scores and have been standardized to a reference population (mean, 50; SD, 10). Clinically meaningful change is considered to be at least half the SD (5 points). Higher T-score indicates better outcome. | 2 years of follow-up |
| 38134265 | Derived | Hage S, Kinkade S, Girard R, Flemming KD, Kim H, Torbey MT, Huang J, Huston J 3rd, Shu Y, Selwyn RG, Hart BL, Mabray MC, Feghali J, Sair HI, Narvid J, Lupo JM, Lee J, Stadnik A, Alcazar-Felix RJ, Shenkar R, Hobson N, DeBiasse D, Lane K, McBee NA, Treine K, Ostapkovich N, Wang Y, Thompson RE, Koenig JI, Carroll T, Hanley DF Jr, Awad IA. Trial Readiness of Cavernous Malformations With Symptomatic Hemorrhage, Part II: Biomarkers and Trial Modeling. Stroke. 2024 Jan;55(1):31-39. doi: 10.1161/STROKEAHA.123.044083. Epub 2023 Dec 22. |
| 37333396 | Derived | Hage S, Kinkade S, Girard R, Flemming KD, Kim H, Torbey MT, Huang J, Huston J, Shu Y, Selwyn RG, Hart BL, Mabray MC, Feghali J, Sair HI, Narvid J, Lupo JM, Lee J, Stadnik A, Alcazar R, Shenkar R, Hobson N, DeBiasse D, Lane K, McBee N, Treine K, Ostapkovich N, Wang Y, Thompson RE, Mendoza-Puccini C, Koenig J, Carroll T, Hanley DF, Awad IA. Cavernous Angioma Symptomatic Hemorrhage (CASH) Trial Readiness II: Imaging Biomarkers and Trial Modeling. medRxiv [Preprint]. 2023 Jun 5:2023.06.01.23290854. doi: 10.1101/2023.06.01.23290854. |
| Years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Familial cavernous malformation syndrome | Data were missing for 2 participants | Count of Participants | Participants |
|
| History of hypertension | Count of Participants | Participants |
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| History of diabetes | Count of Participants | Participants |
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| Tobacco use | Count of Participants | Participants |
|
| Obstructive sleep apnea | Data were missing for 12 participants | Count of Participants | Participants |
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| Alcohol use | Count of Participants | Participants |
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| Statin use | Count of Participants | Participants |
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| Vitamin D supplementation | Count of Participants | Participants |
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| Propranolol | Count of Participants | Participants |
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| Birth control | 75 participants were females for whom birth control could be assessed | Count of Participants | Participants |
|
| Systolic blood pressure, mm Hg | Data were missing for 8 participants | Mean | Standard Deviation | mmHg |
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| Diastolic blood pressure, mm Hg | Data were missing for 8 participants | Mean | Standard Deviation | mmHg |
|
| Body mass index | Mean | Standard Deviation | kg/m^2 |
|
| Qualifying Symptomatic Hemorrhage (SH) location: Brainstem | Count of Participants | Participants |
|
| Units | Counts |
|---|---|
| Participants |
|
|
| Secondary | Percent Change in QSM Value (Lesional Iron Content) | Change in QSM value (lesional iron content) will be presented as a mean value across all participants from baseline to year 1 and year 1 to year 2 follow-up MRIs | Posted | Mean | Standard Deviation | percent change | 2 years of follow-up |
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| Secondary | Percent Change in Contrast-enhanced Quantitative Perfusion (DCEQP) Value (Vascular Permeability) | Change in DCEQP value (vascular permeability) will be presented as a mean value across all participants from baseline to year 1 and year 1 to year 2 follow-up MRIs | Posted | Mean | Standard Deviation | percent change | 2 years of follow-up |
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| Secondary | Compare the Number of Patients With MRS 2 or Higher Who Had Prospective Symptomatic Hemorrhage to Those With MRS 2 or Higher Without Prospective Symptomatic Hemorrhage During the 2 Year Follow-up Period. | Compare the number of patients with MRS 2 or higher who had prospective symptomatic hemorrhage to those with MRS 2 or higher without prospective symptomatic hemorrhage from baseline to year 1 and year 1 to year 2 follow-up periods. The mRS is a simple global measure of functional disability. Scores range from 0 (no symptoms) to 6 (death). An mRS score of 0 to 1 is considered a minimal clinical disability, and 0 to 2 is independent. | At year 1, 5 participants with symptomatic hemorrhage were analyzed, and 97 without symptomatic hemorrhage totaling, 102 participants analyzed. At year 2, 7 participants with symptomatic hemorrhage were analyzed, and 62 without symptomatic hemorrhage, totaling 69 participants analyzed. | Posted | Count of Participants | Participants | 2 years of follow-up |
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| Secondary | Percentage of Patients With National Institutes of Health Stroke Scale (NIHSS) 0-4, 5-14 and 14+ During the 2 Year Follow-up Period. | Percentage of patients with National Institutes of Health Stroke Scale (NIHSS) 0-4, 5-14 and 14+ from baseline to year 1 and year 1 to year 2 follow-up periods. NIHSS values range from 0 to 42, with stroke severity categorized as mild (0 to 4), moderate (5 to 14), severe (15 to 24), and very severe (≥25). 4-point decline in ischemic stroke clinical trials typically measures functional decline. | Posted | Count of Participants | Participants | 2 years of follow-up |
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| Secondary | Median Score of European Quality of Life Visual Analogue Scale (EQ-VAS) During the 2 Year Follow-up Period. | Median score of European Quality of Life Visual Analogue Scale (EQ-VAS) at baseline, year 1, year 2. The EQ-VAS is a vertical visual analogue scale that takes values between 100 (best imaginable health) and 0 (worst imaginable health), on which patients provide a global assessment of their health. | Posted | Median | Full Range | score on a scale | 2 years of follow-up |
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| Secondary | Proportion of Patients With No Problems, Mild Problems, or Severe Problems in the "Mobility" Domain of European Quality of Life 5 Dimensions 3 Level Version (EQ-5D-3 L) During the 2 Year Follow-up Period. | Proportion of patients with no problems, mild problems, or severe problems in the "Mobility" domain of EQ-5D-3 L will be assessed at baseline, year 1, and year 2 follow-up periods. EQ-5D-3 L is a generic tool for Patient Reported Outcomes (PRO) measurement that can assess patients' quality of life, irrespective of the disease and includes 5 domains: mobility, self-care, usual activities, pain/discomfort, and anxiety/depression. There are 3 questions per domain where patients respond if they have no problems, mild, or severe problems. | Posted | Count of Participants | Participants | 2 years of follow-up |
|
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| Secondary | Proportion of Patients With No Problems, Mild Problems, or Severe Problems in the "Self-care" Domain of European Quality of Life 5 Dimensions 3 Level Version (EQ-5D-3 L) During the 2 Year Follow-up Period. | Proportion of patients with no problems, mild problems, or severe problems in the "Self-care" domain of EQ-5D-3 L will be assessed at baseline, year 1, and year 2 follow-up periods. EQ-5D-3 L is a generic tool for Patient Reported Outcomes (PRO) measurement that can assess patients' quality of life, irrespective of the disease and includes 5 domains: mobility, self-care, usual activities, pain/discomfort, and anxiety/depression. There are 3 questions per domain where patients respond if they have no problems, mild, or severe problems. | Posted | Count of Participants | Participants | 2 years of follow-up |
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| Secondary | Proportion of Patients With No Problems, Mild Problems, or Severe Problems in the "Usual Activities" Domain of European Quality of Life 5 Dimensions 3 Level Version (EQ-5D-3 L) During the 2 Year Follow-up Period. | Proportion of patients with no problems, mild problems, or severe problems in the "Usual activities" domain of EQ-5D-3 L will be assessed at baseline, year 1, and year 2 follow-up periods. EQ-5D-3 L is a generic tool for Patient Reported Outcomes (PRO) measurement that can assess patients' quality of life, irrespective of the disease and includes 5 domains: mobility, self-care, usual activities, pain/discomfort, and anxiety/depression. There are 3 questions per domain where patients respond if they have no problems, mild, or severe problems. | Posted | Count of Participants | Participants | 2 years of follow-up |
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| Secondary | Proportion of Patients With No Problems, Mild Problems, or Severe Problems in the "Pain / Discomfort" Domain of European Quality of Life 5 Dimensions 3 Level Version (EQ-5D-3 L) During the 2 Year Follow-up Period. | Proportion of patients with no problems, mild problems, or severe problems in the "Pain / Discomfort" domain of EQ-5D-3 L will be assessed at baseline, year 1, and year 2 follow-up periods. EQ-5D-3 L is a generic tool for Patient Reported Outcomes (PRO) measurement that can assess patients' quality of life, irrespective of the disease and includes 5 domains: mobility, self-care, usual activities, pain/discomfort, and anxiety/depression. There are 3 questions per domain where patients respond if they have no problems, mild, or severe problems. | Posted | Count of Participants | Participants | 2 years of follow-up |
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| Secondary | Proportion of Patients With No Problems, Mild Problems, or Severe Problems in the "Anxiety / Depression" Domain of European Quality of Life 5 Dimensions 3 Level Version (EQ-5D-3 L) During the 2 Year Follow-up Period. | Proportion of patients with no problems, mild problems, or severe problems in the "Anxiety / Depression" domain of EQ-5D-3 L will be assessed at baseline, year 1, and year 2 follow-up periods. EQ-5D-3 L is a generic tool for Patient Reported Outcomes (PRO) measurement that can assess patients' quality of life, irrespective of the disease and includes 5 domains: mobility, self-care, usual activities, pain/discomfort, and anxiety/depression. There are 3 questions per domain where patients respond if they have no problems, mild, or severe problems. | Posted | Count of Participants | Participants | 2 years of follow-up |
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| Secondary | Median T-score for "Anxiety" Domain of Patient-Reported Outcome Measurement Information System (PROMIS-29) During the 2 Year Follow-up Period. | Median T-score for "Anxiety" domain of Patient-Reported Outcome Measurement Information System (PROMIS-29) at baseline, year 1 and year 2. PROMIS-29 (Version 2.0) is a generic health-related quality of life measure including 7 domains (depression, anxiety, physical function, pain interference, fatigue, sleep disturbance, and ability to participate in social roles and activities).12 Each domain contains questions ranked using a 5-point Likert scale. PROMIS-29 domain scores are converted to T scores and have been standardized to a reference population (mean, 50; SD, 10). Clinically meaningful change is considered to be at least half the SD (5 points). Higher T-score indicates better outcome. | Posted | Median | Full Range | T-score | 2 years of follow-up |
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| Secondary | Median T-score for "Depression" Domain of Patient-Reported Outcome Measurement Information System (PROMIS-29) During the 2 Year Follow-up Period. | Median T-score for "Depression" domain of Patient-Reported Outcome Measurement Information System (PROMIS-29) at baseline, year 1, and year 2. PROMIS-29 (Version 2.0) is a generic health-related quality of life measure including 7 domains (depression, anxiety, physical function, pain interference, fatigue, sleep disturbance, and ability to participate in social roles and activities).12 Each domain contains questions ranked using a 5-point Likert scale. PROMIS-29 domain scores are converted to T scores and have been standardized to a reference population (mean, 50; SD, 10). Clinically meaningful change is considered to be at least half the SD (5 points). Higher T-score indicates better outcome. | Posted | Median | Full Range | T-score | 2 years of follow-up |
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| Secondary | Median T-score for "Fatigue" Domain of Patient-Reported Outcome Measurement Information System (PROMIS-29) During the 2 Year Follow-up Period. | Median T-score for "Fatigue" domain of Patient-Reported Outcome Measurement Information System (PROMIS-29) at baseline, year 1, and year 2. PROMIS-29 (Version 2.0) is a generic health-related quality of life measure including 7 domains (depression, anxiety, physical function, pain interference, fatigue, sleep disturbance, and ability to participate in social roles and activities).12 Each domain contains questions ranked using a 5-point Likert scale. PROMIS-29 domain scores are converted to T scores and have been standardized to a reference population (mean, 50; SD, 10). Clinically meaningful change is considered to be at least half the SD (5 points). Higher T-score indicates better outcome. | Posted | Median | Full Range | T-score | 2 years of follow-up |
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| Secondary | Median T-score for "Pain" Domain of Patient-Reported Outcome Measurement Information System (PROMIS-29) During the 2 Year Follow-up Period. | Median T-score for "Pain" domain of Patient-Reported Outcome Measurement Information System (PROMIS-29) at baseline, year 1 and year 2. PROMIS-29 (Version 2.0) is a generic health-related quality of life measure including 7 domains (depression, anxiety, physical function, pain interference, fatigue, sleep disturbance, and ability to participate in social roles and activities).12 Each domain contains questions ranked using a 5-point Likert scale. PROMIS-29 domain scores are converted to T scores and have been standardized to a reference population (mean, 50; SD, 10). Clinically meaningful change is considered to be at least half the SD (5 points). Higher T-score indicates better outcome. | Posted | Median | Full Range | T-score | 2 years of follow-up |
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| Secondary | Median T-score for "Sleep Disturbance" Domain of Patient-Reported Outcome Measurement Information System (PROMIS-29) During the 2 Year Follow-up Period. | Median T-score for "Sleep Disturbance" domain of Patient-Reported Outcome Measurement Information System (PROMIS-29) at baseline, year 1 and year 2. PROMIS-29 (Version 2.0) is a generic health-related quality of life measure including 7 domains (depression, anxiety, physical function, pain interference, fatigue, sleep disturbance, and ability to participate in social roles and activities).12 Each domain contains questions ranked using a 5-point Likert scale. PROMIS-29 domain scores are converted to T scores and have been standardized to a reference population (mean, 50; SD, 10). Clinically meaningful change is considered to be at least half the SD (5 points). Higher T-score indicates better outcome. | Posted | Median | Full Range | T-score | 2 years of follow-up |
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| Secondary | Median T-score for "Social" Domain of Patient-Reported Outcome Measurement Information System (PROMIS-29) During the 2 Year Follow-up Period. | Median T-score for "Social" domain of Patient-Reported Outcome Measurement Information System (PROMIS-29) at baseline, year 1 and year 2. PROMIS-29 (Version 2.0) is a generic health-related quality of life measure including 7 domains (anxiety, depression, fatigue, pain interference, sleep disturbance, and ability to participate in social roles and activities, and physical function).12 Each domain contains questions ranked using a 5-point Likert scale. PROMIS-29 domain scores are converted to T scores and have been standardized to a reference population (mean, 50; SD, 10). Clinically meaningful change is considered to be at least half the SD (5 points). Higher T-score indicates better outcome. | Posted | Median | Full Range | T-score | 2 years of follow-up |
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| Secondary | Median T-score for "Physical Function" Domain of Patient-Reported Outcome Measurement Information System (PROMIS-29) During the 2 Year Follow-up Period. | Median T-score for "Physical Function" domain of Patient-Reported Outcome Measurement Information System (PROMIS-29) at baseline, year 1 and year 2. PROMIS-29 (Version 2.0) is a generic health-related quality of life measure including 7 domains (anxiety, depression, fatigue, pain interference, sleep disturbance, and ability to participate in social roles and activities, and physical function).12 Each domain contains questions ranked using a 5-point Likert scale. PROMIS-29 domain scores are converted to T scores and have been standardized to a reference population (mean, 50; SD, 10). Clinically meaningful change is considered to be at least half the SD (5 points). Higher T-score indicates better outcome. | Posted | Median | Full Range | T-score | 2 years of follow-up |
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| 0 |
| 0 |
| 0 |
| 0 |
| 0 |
| 0 |
Not provided
Not provided
| D000096826 |
| Cavernous Sinus Syndromes |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
| D020785 | Central Nervous System Vascular Malformations |
| D009421 | Nervous System Malformations |
| D054079 | Vascular Malformations |
| D018376 | Cardiovascular Abnormalities |
| D002318 | Cardiovascular Diseases |
| D020141 | Hemostatic Disorders |
| D014652 | Vascular Diseases |
| D006474 | Hemorrhagic Disorders |
| D006402 | Hematologic Diseases |
| D006425 | Hemic and Lymphatic Diseases |
| D000013 | Congenital Abnormalities |
| D009358 | Congenital, Hereditary, and Neonatal Diseases and Abnormalities |
| No symptomatic hemorrhage |
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| NIHSS score 14+ |
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| Severe Problems |
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| Title | Measurements |
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| Severe problems |
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| Title | Measurements |
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| Severe problems |
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| Title | Measurements |
|---|---|
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| Severe problems |
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| Title | Measurements |
|---|---|
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| Severe problems |
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