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| ID | Type | Description | Link |
|---|---|---|---|
| R01NS077706 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| National Institute of Neurological Disorders and Stroke (NINDS) | NIH |
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The primary objective of this Phase 2 HASTIER study, as an ancillary study to ICTuS 2, is to compare key imaging measurements for serial changes in recanalization and reperfusion between hypothermia and normothermia treatment arms as intermediate outcomes of treatment effect. Secondary exploratory analyses include imaging of the neurovascular impact of reperfusion with hypothermia and tPA, including blood-brain barrier changes or permeability, hemorrhagic transformation, and infarct growth.
A prospective imaging ancillary study coincides with recruitment of ICTuS 2 by using currently available imaging tools at a subset of multicenter sites. HASTIER will evaluate therapeutic response with imaging outcome measures for recanalization and reperfusion. Key scientific objectives include the evaluation of hypothermia on benchmark recanalization and reperfusion rates in 120 cases of middle cerebral artery (MCA) stroke. Recanalization will be measured with Thrombolysis in Myocardial Infarction (TIMI) score change from baseline-36 hour CT/MRI angiography. Reperfusion will be measured with Tmax > 6s lesion volume change from baseline-36 hour CT/MRI perfusion imaging. Secondary outcomes will be measured with serial changes in permeability abnormalities derived from CT/MRI perfusion imaging, hemorrhagic transformation, and infarct growth from baseline-36 hours. Correlation of these imaging parameters with clinical outcomes will provide insight to accelerate research during these translational steps in hypothermia treatment for acute ischemic stroke.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Normothermia | Active Comparator | IV t-PA and normothermia |
|
| Hypothermia | Active Comparator | IV t-PA and hypothermia |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| IV t-PA and normothermia | Other |
|
| |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants With Recanalization | To determine whether hypothermia alters recanalization with standard thrombolytic treatment with intravenous (IV) tissue plasminogen activator (tPA) for acute ischemic stroke in humans. The hypothesis is that hypothermia does not impair recanalization (opening of the artery). Recanalization will be measured with Thrombolysis in Myocardial Infarction (TIMI) score change from baseline angiography to 36 hour angiography. TIMI is cored per published definition. Additional data for secondary analyses were not acquired to permit analyses. | 36 hours |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| David S Liebeskind, MD | University of California, Los Angeles | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Cedars-Sinai Medical Center | Los Angeles | California | 90048 | United States | ||
| University of California, San Diego |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 17904009 | Background | Lyden PD, Allgren RL, Ng K, Akins P, Meyer B, Al-Sanani F, Lutsep H, Dobak J, Matsubara BS, Zivin J. Intravascular Cooling in the Treatment of Stroke (ICTuS): early clinical experience. J Stroke Cerebrovasc Dis. 2005 May-Jun;14(3):107-14. doi: 10.1016/j.jstrokecerebrovasdis.2005.01.001. | |
| 20724711 | Background | Hemmen TM, Raman R, Guluma KZ, Meyer BC, Gomes JA, Cruz-Flores S, Wijman CA, Rapp KS, Grotta JC, Lyden PD; ICTuS-L Investigators. Intravenous thrombolysis plus hypothermia for acute treatment of ischemic stroke (ICTuS-L): final results. Stroke. 2010 Oct;41(10):2265-70. doi: 10.1161/STROKEAHA.110.592295. Epub 2010 Aug 19. |
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| ID | Title | Description |
|---|---|---|
| FG000 | Normothermia | IV t-PA and normothermia |
| FG001 | Hypothermia | IV t-PA and hypothermia |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Normothermia | IV t-PA and normothermia |
| BG001 | Hypothermia | IV t-PA and hypothermia |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| 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 | Number of Participants With Recanalization | To determine whether hypothermia alters recanalization with standard thrombolytic treatment with intravenous (IV) tissue plasminogen activator (tPA) for acute ischemic stroke in humans. The hypothesis is that hypothermia does not impair recanalization (opening of the artery). Recanalization will be measured with Thrombolysis in Myocardial Infarction (TIMI) score change from baseline angiography to 36 hour angiography. TIMI is cored per published definition. Additional data for secondary analyses were not acquired to permit analyses. | Recanalization at 36 hours | Posted | Count of Participants | Participants | No | 36 hours |
|
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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 | Normothermia | IV t-PA and normothermia |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Congestive Heart Failure | Cardiac disorders |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Abnormal coagulation profile | Blood and lymphatic system disorders |
Early termination of ancillary study leading to small numbers of subjects analyzed.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| David S Liebeskind, MD | UCLA | 310-794-6379 | dliebeskind@mednet.ucla.edu |
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| ID | Term |
|---|---|
| D000083242 | Ischemic Stroke |
| D020521 | Stroke |
| D007035 | Hypothermia |
| ID | Term |
|---|---|
| D002561 | Cerebrovascular Disorders |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
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| ID | Term |
|---|---|
| D059039 | Standard of Care |
| ID | Term |
|---|---|
| D019984 | Quality Indicators, Health Care |
| D011787 | Quality of Health Care |
| D006298 | Health Services Administration |
| D017530 | Health Care Quality, Access, and Evaluation |
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| IV-tPA and hypothermia |
| Device |
|
|
| San Diego |
| California |
| 92093 |
| United States |
| Intercoastal Medical Group | Sarasota | Florida | 34232 | United States |
| BG002 |
| Total |
Total of all reporting groups |
| Participants |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
IV t-PA and hypothermia |
|
|
| 1 |
| 2 |
| 2 |
| 2 |
| EG001 | Hypothermia | IV t-PA and hypothermia | 1 | 4 | 4 | 4 |
| Death | Nervous system disorders |
|
| Agitation | Psychiatric disorders |
|
| Anemia | Blood and lymphatic system disorders |
|
| Aspiration pneumonitis | Respiratory, thoracic and mediastinal disorders |
|
| Atrial fibrillation | Cardiac disorders |
|
| Cerebral edema | Nervous system disorders |
|
| Constipation | Gastrointestinal disorders |
|
| Dysphagia | Gastrointestinal disorders |
|
| Elevated troponin | Cardiac disorders |
|
| Fever | Infections and infestations |
|
| Fluid overload | Vascular disorders |
|
| Headache | Nervous system disorders |
|
| Hyperglycemia | Endocrine disorders |
|
| Hyperkalemia | Metabolism and nutrition disorders |
|
| Hyperlipidemia | Metabolism and nutrition disorders |
|
| Hypertension | Vascular disorders |
|
| Hypocalcemia | Metabolism and nutrition disorders |
|
| Hypokalemia | Metabolism and nutrition disorders |
|
| Hyponatremia | Metabolism and nutrition disorders |
|
| Hypotension | Vascular disorders |
|
| Leukocytosis | Blood and lymphatic system disorders |
|
| Nausea | Gastrointestinal disorders |
|
| Pain | Nervous system disorders |
|
| Pneumonia | Respiratory, thoracic and mediastinal disorders |
|
| Rhabdomyolysis | Musculoskeletal and connective tissue disorders |
|
| Topical fungal infection | Infections and infestations |
|
| Transaminitis | Hepatobiliary disorders |
|
| Urinary tract infection | Infections and infestations |
|
| Vomiting | Gastrointestinal disorders |
|
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| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
| D001832 | Body Temperature Changes |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |