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Complete occlusion of the Internal carotid artery (ICA) by atherosclerotic disease (COICA) causes approximately 15%-25% of ischemic strokes in the carotid artery distribution. Patients treated with medical therapy have a 7%-10% risk of recurrent stroke per year for any stroke and a 5%-8% risk per year for ipsilateral ischemic stroke during the first 2 years after ICA occlusion. Internal carotid artery occlusion causes an estimated 61,000 first-ever strokes per year in the US an incidence more than twice the annual occurrence of ruptured intracranial aneurysms Additionally, 40% of subjects with COICA who present with transient ischemic attack (TIA) and 70% of COICA who present with stroke have cognitive decline with increased risk of vascular dementia and Alzheimer's' disease (AD) with time (2,3).
Symptomatic COICA subjects are at increased risk of developing cognitive impairment and progressive development of vascular dementia and AD with time. Our proposal leverages several compelling retrospective and prospective preliminary data from human to perform this exploratory trial with go/no-go criteria to proceed to a phase 3 based on the data generated
Study Design:
Prospective randomized open blinded end-point (PROBE) study
This is a phase 2 randomized single-center open label clinical trial with randomization of 1:1 to either best medical management vs. best medical management and endovascular revascularization of COICA.
Screening, Enrolling, & Randomization:
All subjects who presents to our tertiary hospital with a diagnosis of COICA will undergo full evaluation including 1) documenting previous history of transient ischemic attack (TIA) and/or stroke; 2) cervical and brain CT angiography (CTA) to document complete occlusion; 3) CT perfusion (CTP) to assess for presence of penumbra evident by increased mean transient time (MTT) in the ipsilateral side of COICA; and 4) Montreal cognitive assessment (MoCA) score. If any subject is found to have complete occlusion of COICA, evident of abnormal/prolongation of MTT on CTP, previous history of TIA and or stroke, and MoCA <26 or abnormal response on another neuropsychological assessment preformed in the screening battery, then further evaluation is obtained including: MRI spectroscopy to assess for presence/absence of lactate in the ipsilateral watershed area (centrum semiovale), and size of ipsilateral hippocampus and amygdala, additional cognitive testing battery, and digital subtraction angiography (DSA) to document adequately the type of COICA the subject have (type A-D).
If a subject meets all inclusion criteria (complete occlusion, MoCA <26 and/or abnormal other neuropsychological test result, abnormal CTP) they will be randomized, after consent is obtained. If all inclusion criteria are met other than the CTP, they will be enrolled but not randomized. These subjects will only be eligible for best medical management- not surgical intervention.
If any subject does not have complete occlusion or abnormal MoCA >26 or other neuropsychological assessment, then the subject is excluded and no further testing needed (see exclusion criteria).
If the subject meets all inclusion criteria, then a baseline of complete neurological testing, full demographics, CTA or MRA, CTP, MoCA, additional neurological testing, MRI spectroscopy and DSA are obtained and subject is randomized 1:1 to either best medical management or best medical management + endovascular balloon angioplasty and stenting. Follow up clinic visits are arranged at 6 and 12 months. Repeat testing of MoCA and additional cognitive testing battery are done at these clinical follow-up visits (6 and 12 months). MRI of the brain and is done at 6 and 12 months. DSA is performed at 1 year follow-up for intervention subjects to assess brain bio-markers and revascularization respectively.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Endovascular arm | Experimental | Subjects meet all inclusion criteria and were randomized to intervention |
|
| Medical arm | Active Comparator | Subjects meet all inclusion criteria and were randomized to best medical management |
|
| Non-Randomized Arm | Active Comparator | Subject meets all inclusion criteria EXCEPT abnormal CTP. Subjects are not randomized and are eligible for only best medical management |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Endovascular intervention | Procedure | Endovascular angioplasty of the occluded carotid using balloon angioplasty and reconstruction with stents: coronary stents distally (Rebel, Boston Scientific; Vision, Abbott Vascular) and carotid stents proximal (Acculink and Xcat, Abbott Vascular) Patients will stay on their aspirin 325 mg and clopidogrel 75 mg |
| Measure | Description | Time Frame |
|---|---|---|
| Change in Montreal Cognitive Assessment (MoCA) Score | The MoCA is a screening tool used to assess cognitive function. The possible score range is 0 to 30, with higher scores indicating better cognitive performance. | Baseline, 6 months, 12 months |
| Change in Composite Cognitive Score | This outcome reflects overall cognition. The composite z score is based on average z scores for the tests for each subject (sum of the z scores divided by the number of tests included) from a specifically designed battery of 14 cognitive tests: Montreal Cognitive Assessment (MoCA),Wide Range Achievement Test-5 (WRAT-5); Wechsler Adult Intelligence Scale - IV (WAIS-IV); WAIS-IV, Coding subtest; WAIS-IV, Matrix Reasoning subtest; Hopkins Verbal Learning Test; Benton Visual Retention Test (BVRT); Controlled Oral Word Association (COWA) Test; Boston Naming Test; Boston Diagnostic Aphasia Examination, Complex Ideational Material subtest; Trail-Making Test, part A and part B; Beck Depression Inventory-Fast Screen (BDI-FS); Iowa Scales of Personality Change (ISPC). A Z-score of 0 represents no change. Standard deviations above 0 represent better outcomes; standard deviations below 0 represent worse outcomes. | Baseline, 6 months, 12 months |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants With Stroke Within 30 Days Post Procedure | Up to 30 days post procedure | |
| Number of Participants With Intracranial Hemorrhage Within 72 Hours Post Procedure | Up to 72 hours post procedure |
| Measure | Description | Time Frame |
|---|---|---|
| Change in Mean Transit Time (MTT) on CT Perfusion | MTT is defined as the average time, in seconds, that circulating blood cells needs to pass within a determinate volume of brain. It is assessed as part of the CT perfusion protocol. | Baseline, 12 months |
| Change in Size of Hippocampus |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| David Hasan, MD | Duke University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Iowa hospitals and Clinics | Iowa City | Iowa | 52242 | United States | ||
| Duke University |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 31872191 | Background | Zanaty M, Roa JA, Jabbour PM, Samaniego EA, Hasan DM. Recanalization of the Chronically Occluded Internal Carotid Artery: Review of the Literature. World Neurosurg X. 2019 Nov 21;5:100067. doi: 10.1016/j.wnsx.2019.100067. eCollection 2020 Jan. | |
| 31349074 | Background | Hudson JS, Zanaty M, Wadman V, Nakagawa D, Ishii D, Roa JA, Al Kasabz S, Limaye K, Rossen JD, Jabbour P, Adams HP Jr, Samaniego EA, Hasan DM. Bradycardia and Asystole in Patients Undergoing Symptomatic Chronically Occluded Internal Carotid Artery Recanalization. World Neurosurg. 2019 Nov;131:e211-e217. doi: 10.1016/j.wneu.2019.07.125. Epub 2019 Jul 23. |
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| ID | Title | Description |
|---|---|---|
| FG000 | Endovascular Arm | Subjects meet all inclusion criteria and were randomized to intervention Endovascular intervention: Endovascular angioplasty of the occluded carotid using balloon angioplasty and reconstruction with stents: coronary stents distally (Rebel, Boston Scientific; Vision, Abbott Vascular) and carotid stents proximal (Acculink and Xcat, Abbott Vascular) Patients will stay on their aspirin 325 mg and clopidogrel 75 mg |
| FG001 | Medical Arm | Subjects meet all inclusion criteria and were randomized to best medical management Aspirin and Clopidogrel (maximal medical Therapy): Best Medical Management: daily dual antiplatelet therapy (aspirin: 325 mg p.o. qd and Clopidogrel: 75 mg p.o. qd), optimization of systolic blood pressure (120 -140 mmHg), and smoking cessation. |
| FG002 | Observational Arm | Participants without increased MTT or TPP on CTP may still be included in the unrandomized prospective observational arm. |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Endovascular Arm | Subjects meet all inclusion criteria and were randomized to intervention Endovascular intervention: Endovascular angioplasty of the occluded carotid using balloon angioplasty and reconstruction with stents: coronary stents distally (Rebel, Boston Scientific; Vision, Abbott Vascular) and carotid stents proximal (Acculink and Xcat, Abbott Vascular) Patients will stay on their aspirin 325 mg and clopidogrel 75 mg |
| 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 | Change in Montreal Cognitive Assessment (MoCA) Score | The MoCA is a screening tool used to assess cognitive function. The possible score range is 0 to 30, with higher scores indicating better cognitive performance. | Participants with data collected at both timepoints for each comparison. | Posted | Mean | Standard Deviation | score on a scale | Baseline, 6 months, 12 months |
|
Up to 12 months
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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 | Endovascular Arm | Subjects meet all inclusion criteria and were randomized to intervention Endovascular intervention: Endovascular angioplasty of the occluded carotid using balloon angioplasty and reconstruction with stents: coronary stents distally (Rebel, Boston Scientific; Vision, Abbott Vascular) and carotid stents proximal (Acculink and Xcat, Abbott Vascular) Patients will stay on their aspirin 325 mg and clopidogrel 75 mg |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Acute blood loss anemia | Blood and lymphatic system disorders | Non-systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Acute blood loss anemia | Blood and lymphatic system disorders | Non-systematic Assessment |
The Observation Arm was not included in comparison. It is a non-equivalent group because patients included in the Arm if they were ineligible based on baseline measures and consent to randomization.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| David Hasan, MD, MSc | Duke University | 919-684-7777 | david.hasan@duke.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 | Oct 12, 2021 | Mar 10, 2025 | Prot_SAP_001.pdf |
| ICF | No | No | Yes | Informed Consent Form | Apr 20, 2023 | Jun 13, 2023 | ICF_000.pdf |
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| ID | Term |
|---|---|
| D003072 | Cognition Disorders |
| D020521 | Stroke |
| ID | Term |
|---|---|
| D019965 | Neurocognitive Disorders |
| D001523 | Mental Disorders |
| D002561 | Cerebrovascular Disorders |
| D001927 | Brain Diseases |
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| ID | Term |
|---|---|
| D001241 | Aspirin |
| D000077144 | Clopidogrel |
| ID | Term |
|---|---|
| D012459 | Salicylates |
| D062385 | Hydroxybenzoates |
| D010636 | Phenols |
| D001555 | Benzene Derivatives |
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1:1 randomization, 1 non-randomized active comparator arm
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Prospective randomized open blinded end-point (PROBE) study
|
| Aspirin and Clopidogrel (maximal medical Therapy) | Drug | Best Medical Management: daily dual antiplatelet therapy (aspirin: 325 mg p.o. qd and Clopidogrel: 75 mg p.o. qd), optimization of systolic blood pressure (120 -140 mmHg), and smoking cessation. |
|
| Number of Participant Deaths | Up to 12 months |
The change in size of hippocampus in the ipsilateral side of COICA (t-test), at enrollment vs. 1 year. |
| Baseline, 6 months, 12 months |
| Change in Size of Amygdala | The change in size of amygdala in the ipsilateral side of COICA (t-test), at enrollment vs. 1 year. | Baseline, 6 months, 12 months |
| Number of Participants With the Presence of Lactate on 1H-MRI Spectroscopy | Presence of lactate determined by MRI spectroscopy in centrum semiovale in the ipsilateral side of chronic occlusion of the internal carotid artery (COICA). | Baseline, 6 months, 12 months |
| Durham |
| North Carolina |
| 27710 |
| United States |
| 31298301 | Background | Limaye K, Zanaty M, Hudson J, Nakagawa D, Al Kasab S, Alvarez C, Dandapat S, Kung DK, Ortega-Gutierrez S, Jabbour P, Samaniego EA, Hasan D. The Safety and Efficacy of Continuous Tirofiban as a Monoantiplatelet Therapy in the Management of Ruptured Aneurysms Treated Using Stent-Assisted Coiling or Flow Diversion and Requiring Ventricular Drainage. Neurosurgery. 2019 Dec 1;85(6):E1037-E1042. doi: 10.1093/neuros/nyz226. |
| 30925474 | Background | Zanaty M, Howard S, Roa JA, Alvarez CM, Kung DK, McCarthy DJ, Samaniego EA, Nakagawa D, Starke RM, Limaye K, Al Kasab S, Chalouhi N, Jabbour P, Torner J, Tranel D, Hasan D. Cognitive and cerebral hemodynamic effects of endovascular recanalization of chronically occluded cervical internal carotid artery: single-center study and review of the literature. J Neurosurg. 2019 Mar 29;132(4):1158-1166. doi: 10.3171/2019.1.JNS183337. Print 2020 Apr 1. |
| 30557930 | Background | Zanaty M, Samaniego EA, Hasan DM. Letter to the Editor Regarding "Estimation and Recanalization of Chronic Occluded Internal Carotid Artery: Hybrid Operation by Carotid Endarterectomy and Endovascular Angioplasty". World Neurosurg. 2019 Jan;121:287. doi: 10.1016/j.wneu.2018.09.033. No abstract available. |
| 30312821 | Background | Zanaty M, Samaniego EA, Teferi N, Kung DK, Nakagawa D, Hudson J, Ortega-Gutierrez S, Allan L, Jabbour P, Hasan DM. Hybrid Surgery for Internal Carotid Artery Revascularization. World Neurosurg. 2019 Jan;121:137-144. doi: 10.1016/j.wneu.2018.09.230. Epub 2018 Oct 9. |
| BG001 | Medical Arm | Subjects meet all inclusion criteria and were randomized to best medical management Aspirin and Clopidogrel (maximal medical Therapy): Best Medical Management: daily dual antiplatelet therapy (aspirin: 325 mg p.o. qd and Clopidogrel: 75 mg p.o. qd), optimization of systolic blood pressure (120 -140 mmHg), and smoking cessation. |
| BG002 | Observational Arm | Participants without increased MTT or TPP on CTP may still be included in the unrandomized prospective observational arm. |
| BG003 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race/Ethnicity, Customized | Count of Participants | Participants |
|
| Region of Enrollment | Count of Participants | Participants |
|
| Medical History | Count of Participants | Participants |
|
| MoCA (Montreal Cognitive Assessment) Score | The MoCA is a screening tool used to assess cognitive function. The possible score range is 0 to 30, with higher scores indicating better cognitive performance. | Count of Participants | Participants |
|
| Lesion Grade | A: tapered occlusion of the ICA stump and patent lumen distally with collateral filling from branches of the ECA, posterior communicating artery (Pcom), and/or anterior communicating artery (ACA). B: nontapered ICA stump and patent lumen distally with collateral filling from branches of the ECA, Pcom, and/or ACA. C: no ICA stump and patent lumen distally with collateral filling, from branches of the ECA, Pcom, and/or ACA. D: no ICA stump and occluded lumen distally until the ICA bifurcation. | Count of Participants | Participants |
|
| Lesion Location | Count of Participants | Participants |
|
| OG001 |
| Medical Arm |
Subjects meet all inclusion criteria and were randomized to best medical management Aspirin and Clopidogrel (maximal medical Therapy): Best Medical Management: daily dual antiplatelet therapy (aspirin: 325 mg p.o. qd and Clopidogrel: 75 mg p.o. qd), optimization of systolic blood pressure (120 -140 mmHg), and smoking cessation. |
| OG002 | Observational Arm | Participants without increased MTT or TPP on CTP may still be included in the unrandomized prospective observational arm. |
|
|
| Primary | Change in Composite Cognitive Score | This outcome reflects overall cognition. The composite z score is based on average z scores for the tests for each subject (sum of the z scores divided by the number of tests included) from a specifically designed battery of 14 cognitive tests: Montreal Cognitive Assessment (MoCA),Wide Range Achievement Test-5 (WRAT-5); Wechsler Adult Intelligence Scale - IV (WAIS-IV); WAIS-IV, Coding subtest; WAIS-IV, Matrix Reasoning subtest; Hopkins Verbal Learning Test; Benton Visual Retention Test (BVRT); Controlled Oral Word Association (COWA) Test; Boston Naming Test; Boston Diagnostic Aphasia Examination, Complex Ideational Material subtest; Trail-Making Test, part A and part B; Beck Depression Inventory-Fast Screen (BDI-FS); Iowa Scales of Personality Change (ISPC). A Z-score of 0 represents no change. Standard deviations above 0 represent better outcomes; standard deviations below 0 represent worse outcomes. | Participants with data collected at both timepoints for each comparison. | Posted | Mean | Standard Deviation | z-score | Baseline, 6 months, 12 months |
|
|
|
| Secondary | Number of Participants With Stroke Within 30 Days Post Procedure | Posted | Count of Participants | Participants | Up to 30 days post procedure |
|
|
|
| Secondary | Number of Participants With Intracranial Hemorrhage Within 72 Hours Post Procedure | Posted | Count of Participants | Participants | Up to 72 hours post procedure |
|
|
|
| Secondary | Number of Participant Deaths | Posted | Count of Participants | Participants | Up to 12 months |
|
|
|
| Other Pre-specified | Change in Mean Transit Time (MTT) on CT Perfusion | MTT is defined as the average time, in seconds, that circulating blood cells needs to pass within a determinate volume of brain. It is assessed as part of the CT perfusion protocol. | Participants with data collected at both timepoints. | Posted | Mean | Standard Deviation | seconds | Baseline, 12 months |
|
|
|
| Other Pre-specified | Change in Size of Hippocampus | The change in size of hippocampus in the ipsilateral side of COICA (t-test), at enrollment vs. 1 year. | Participants with data collected at both timepoints. | Posted | Mean | Standard Deviation | cm^3 | Baseline, 6 months, 12 months |
|
|
|
| Other Pre-specified | Change in Size of Amygdala | The change in size of amygdala in the ipsilateral side of COICA (t-test), at enrollment vs. 1 year. | Participants with data collected at both timepoints. | Posted | Mean | Standard Deviation | cm^3 | Baseline, 6 months, 12 months |
|
|
|
| Other Pre-specified | Number of Participants With the Presence of Lactate on 1H-MRI Spectroscopy | Presence of lactate determined by MRI spectroscopy in centrum semiovale in the ipsilateral side of chronic occlusion of the internal carotid artery (COICA). | Participants with data collected at each timepoint. | Posted | Count of Participants | Participants | Baseline, 6 months, 12 months |
|
|
|
| 1 |
| 12 |
| 6 |
| 12 |
| 10 |
| 12 |
| EG001 | Medical Arm | Subjects meet all inclusion criteria and were randomized to best medical management Aspirin and Clopidogrel (maximal medical Therapy): Best Medical Management: daily dual antiplatelet therapy (aspirin: 325 mg p.o. qd and Clopidogrel: 75 mg p.o. qd), optimization of systolic blood pressure (120 -140 mmHg), and smoking cessation. | 1 | 13 | 6 | 13 | 8 | 13 |
| EG002 | Observational Arm | Participants without increased MTT or TPP on CTP may still be included in the unrandomized prospective observational arm. | 0 | 6 | 3 | 6 | 4 | 6 |
| Acute respiratory failure | Respiratory, thoracic and mediastinal disorders | Non-systematic Assessment |
|
| Acute systolic heart failure | Cardiac disorders | Non-systematic Assessment |
|
| Anemia | Blood and lymphatic system disorders | Non-systematic Assessment |
|
| Colitis | Gastrointestinal disorders | Non-systematic Assessment |
|
| EVD malfunction | Investigations | Non-systematic Assessment |
|
| Expressive Aphasia | Nervous system disorders | Non-systematic Assessment |
|
| Femoral Pseudoaneurysm | Blood and lymphatic system disorders | Non-systematic Assessment |
|
| Hydrocephalus | Nervous system disorders | Non-systematic Assessment |
|
| Infarct | Cardiac disorders | Non-systematic Assessment |
|
| Intraparenchymal hemorrhage | Cardiac disorders | Non-systematic Assessment |
|
| Myelodysplastic Syndrome | Blood and lymphatic system disorders | Non-systematic Assessment |
|
| Perinephric hematoma | Blood and lymphatic system disorders | Non-systematic Assessment |
|
| Posterior vitreous hemorrhage | Blood and lymphatic system disorders | Non-systematic Assessment |
|
| Regressed neovascularization | Blood and lymphatic system disorders | Non-systematic Assessment |
|
| Retroperitoneal hematoma | Blood and lymphatic system disorders | Non-systematic Assessment |
|
| Stage 4 Urothelial cancer | Renal and urinary disorders | Non-systematic Assessment |
|
| LICA | Cardiac disorders | Non-systematic Assessment |
|
| Small bowel and Cecal AVM | Gastrointestinal disorders | Non-systematic Assessment |
|
| Subacute Chronic Infarcts | Cardiac disorders | Non-systematic Assessment |
|
| Subarachnoid hemorrhage | Blood and lymphatic system disorders | Non-systematic Assessment |
|
| Tonic Clonic Seizures | Nervous system disorders | Non-systematic Assessment |
|
| Subclinical seizures | Nervous system disorders | Non-systematic Assessment |
|
| Colon Re-section | Surgical and medical procedures | Non-systematic Assessment |
|
| Lung mass | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | Non-systematic Assessment |
|
| Mechanical Fall and Facial T | General disorders | Non-systematic Assessment |
|
| Syncopal Fall | General disorders | Non-systematic Assessment |
|
| Altered mental status | Psychiatric disorders | Non-systematic Assessment |
|
| Atrial Fibrillation | Cardiac disorders | Non-systematic Assessment |
|
| Anemia | Blood and lymphatic system disorders | Non-systematic Assessment |
|
| Bloody Stool | Gastrointestinal disorders | Non-systematic Assessment |
|
| Carpal Tunnel | General disorders | Non-systematic Assessment |
|
| Cognitive Impairment | Psychiatric disorders | Non-systematic Assessment |
|
| Decreased Mood | Psychiatric disorders | Non-systematic Assessment |
|
| Diabetes Miletus | Endocrine disorders | Non-systematic Assessment |
|
| Disorientation with Physical Effort | Investigations | Non-systematic Assessment |
|
| Dissection of ECA | Cardiac disorders | Non-systematic Assessment |
|
| Dysphasia | General disorders | Non-systematic Assessment |
|
| Easy Bruising | General disorders | Non-systematic Assessment |
|
| Excessive Bleeding | Blood and lymphatic system disorders | Non-systematic Assessment |
|
| Fatigue | General disorders | Non-systematic Assessment |
|
| Head trauma due to falls | Injury, poisoning and procedural complications | Non-systematic Assessment |
|
| Headache | General disorders | Non-systematic Assessment |
|
| Hematuria | Blood and lymphatic system disorders | Non-systematic Assessment |
|
| High Blood Pressure | Cardiac disorders | Non-systematic Assessment |
|
| Hypotension | Cardiac disorders | Non-systematic Assessment |
|
| Lactic acidosis | Blood and lymphatic system disorders | Non-systematic Assessment |
|
| Memory Impairment | Psychiatric disorders | Non-systematic Assessment |
|
| Myocardial Injury | Cardiac disorders | Non-systematic Assessment |
|
| Nose Bleeds | General disorders | Non-systematic Assessment |
|
| Progressive Cognitive Impairment | Psychiatric disorders | Non-systematic Assessment |
|
| Psychiatric Episode | Psychiatric disorders | Non-systematic Assessment |
|
| Severe Anomia | Nervous system disorders | Non-systematic Assessment |
|
| Transfusion Associated Circulatory Overload | Cardiac disorders | Non-systematic Assessment |
|
| Urinary retention | Renal and urinary disorders | Non-systematic Assessment |
|
| Vaginal bleeding | Reproductive system and breast disorders | Non-systematic Assessment |
|
| Visual Field Deficit | Eye disorders | Non-systematic Assessment |
|
| Wrist Hematoma | General disorders | Non-systematic Assessment |
|
| Swelling in bilateral lower extremities | General disorders | Non-systematic Assessment |
|
| Distal Interphalangeal Fract | Musculoskeletal and connective tissue disorders | Non-systematic Assessment |
|
| Essential Hypertension | Cardiac disorders | Non-systematic Assessment |
|
| Shoulder Arthralgias | Musculoskeletal and connective tissue disorders | Non-systematic Assessment |
|
| Vision Changes | Eye disorders | Non-systematic Assessment |
|
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| D002493 |
| Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
| D006841 |
| Hydrocarbons, Aromatic |
| D006844 | Hydrocarbons, Cyclic |
| D006838 | Hydrocarbons |
| D009930 | Organic Chemicals |
| D013988 | Ticlopidine |
| D058924 | Thienopyridines |
| D013876 | Thiophenes |
| D013457 | Sulfur Compounds |
| D011725 | Pyridines |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| Baseline to 12 months |
|
|
| MTT - Right |
|
|
| Hippocampus - Left (baseline to 12 months) |
|
|
| Hippocampus - Right (baseline to 6 months) |
|
|
| Hippocampus - Right (baseline to 12 months) |
|
|
| Amydala - Left (baseline to 12 months) |
|
|
| Amydala - Right (baseline to 6 months) |
|
|
| Amydala - Right (baseline to 12 months) |
|
|
| 6 months |
|
|
| 12 months |
|
|