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| Name | Class |
|---|---|
| Patient-Centered Outcomes Research Institute | OTHER |
| University of California, Los Angeles | OTHER |
| Icahn School of Medicine at Mount Sinai | OTHER |
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TESTED will compare the risks and benefits of endovascular thrombectomy (EVT) to medical management (no EVT) in ischemic stroke patients who have a blockage in one of the large blood vessels in the brain and have a moderate-to-severe disability prior to their stroke.
People with disabilities can suffer acute ischemic stroke (AIS). Endovascular clot removal is a breakthrough therapy for large vessel occlusion (LVO) AIS. Pre-stroke disabled patients were excluded from pivotal EVT stroke trials, so whether EVT is effective for those with pre-stroke disability is not known. As a result, two competing, widely-practiced, treatment paradigms have emerged based on individual practitioners' extrapolation of EVT benefits and safety from patients without a pre-stroke disability to those with disability: 1) Multimodal Medical Management (MMM; using intravenous thrombolysis, antiplatelets, anti-hypertensives, cholesterol lowering medications, and other rehabilitative measures, as indicated) without EVT, and 2) EVT with the background of MMM.
TESTED will enroll patients with LVO-AIS who have a pre-existing disability, defined as pre-stroke modified Rankin score (mRS) 3 and 4, at 12 geographically distinct comprehensive stroke centers serving diverse race-ethnic and socioeconomic populations. The central objective of TESTED is to determine the comparative effectiveness and safety of these two different practice paradigms.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Stroke patients with moderate-to-severe pre-stroke disability | Patients with pre-stroke modified Rankin scale score 3 or 4, presenting with a anterior circulation large vessel occlusion stroke within 24 hours of last known well |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Endovascular Stroke Treatment | Procedure | Patients who receive endovascular stroke treatment when they are admitted into the hospital, as determined by their clinical care team. Endovascular stroke treatment consist of catheter-based treatment for the blood clot causing the acute ischemic stroke |
| Measure | Description | Time Frame |
|---|---|---|
| modified Rankin Scale (mRS) | Score of 0-3, 4, 5 or 6 on the modified Rankin Scale (mRS) (Note: mRS range: 0 (no residual symptoms) to 6 (death) | 90 (±14) days after treatment initiation |
| Measure | Description | Time Frame |
|---|---|---|
| Disability-weighted (or utility-weighted) mRS | Standard utility weights applied to the mRS categories as follows: 1.0 for mRS level 0; 0.91 for mRS level 1; 0.76 for mRS level 2; 0.65 for mRS level 3; 0.33 for mRS level 4; 0 for mRS level 5; and 0 for mRS level 6 | 90 (±14) days after treatment initiation |
| Measure | Description | Time Frame |
|---|---|---|
| modified Rankin Scale (mRS) | Score of 0-3, 4, 5 or 6 on the modified Rankin Scale (mRS) (Note: mRS range: 0 (no residual symptoms) to 6 (death) | At hospital discharge |
| Montreal Cognitive Assessment (MoCA) |
Inclusion Criteria:
Exclusion Criteria:
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Ischemic stroke patients who have a blockage in one of the large blood vessels in the brain and have a moderate-to-severe disability prior to their stroke. They will be consented up to 72 hours after stroke onset in the acute hospitalization setting.
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Eva Mistry, MD | Contact | 513-558-1291 | mistryea@ucmail.uc.edu | |
| Naima Griffin | Contact | 513-558-0125 | griffna@ucmail.uc.edu |
| Name | Affiliation | Role |
|---|---|---|
| Eva Mistry, MD | University of Cincinnati | Principal Investigator |
| Jeffrey Saver, MD | Ronald Reagan UCLA Medical Center | Principal Investigator |
| J Mocco, MD |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| HonorHealth | Recruiting | Phoenix | Arizona | 85013 | United States |
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One year after completing of the final analysis
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| Medical Management | Other | Patients who receive MMM when they are admitted into the hospital, as determined by their clinical care team. MMM may involve any combination of the following: intravenous thrombolysis, antiplatelets, anti-hypertensives, cholesterol-lowering medications, and rehabilitative care. Specifically, this treatment does not involve endovascular stroke treatment. |
|
| Return to the pre-stroke mRS level |
Returning to the pre-stroke mRS level post stroke |
| 90 (±14) days after treatment initiation |
| EQ-5D-5L | Quality of life assessment scale with range: 0 (worst health) to 100 (best health) | 90 (±14) days after treatment initiation |
| Academic Medical Center - Linear Disability Scale (ALDS) | Generic item bank that measures the disability status of patients with a broad range of diseases, as expressed by the ability to perform activities in daily living. | 90 (±14) days after treatment initiation |
Montreal Cognitive Assessment (MoCA) (Note: MoCA range: 0-30, higher scores mean better outcome)
| 90 (±14) days after treatment initiation |
| Barthel Index Scale | Barthel Index range: 0-100, higher scores mean participant is independent | 90 (±14) days after treatment initiation |
| Initial residence level or better time during first 90 days post-stroke | Number of days spend at the initial residence level or better during the first 90 days post-stroke | 90 days after treatment initiation |
| Zarit's Burden Interview (ZBI) | ZBI is a measure of caregiving burden that includes a 22 item interview. Each item on the interview is a statement which the caregiver is asked to endorse using a 5-point scale. Response options range from 0 (Never) to 4 (Nearly Always). We will use the 4 item version of the ZBI which has good correlation with the full version. | 90 (±14) days after treatment initiation |
| Extended Thrombolysis in Cerebral Ischemia scale | The 7-point scale of eTICI is as follows: eTICI0 = 0% reperfusion; eTICI 1 = minimal flow past the occlusion but no perfusion ; eTICI2a = 1-49% reperfusion; eTICI2b50 = 50-66% reperfusion; eTICI2b67 = 67-89% reperfusion; eTICI2c = 90-99% reperfusion; eTICI3 = complete reperfusion | At the end of EVT procedure |
| Death | 90 (±14) after treatment initiation |
| Symptomatic intracranial hemorrhage | Evaluate modified Heidelberg definition | 24 (±6) hours |
| Icahn School of Medicine at Mount Sinai |
| Principal Investigator |
| Heidi Sucharew, PhD | University of Cincinnati | Principal Investigator |
| Kaiser Permanente Los Angeles Medical Center | Recruiting | Los Angeles | California | 90027 | United States |
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| University of California at Los Angeles | Recruiting | Los Angeles | California | 90095 | United States |
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| Standford | Recruiting | Palo Alto | California | 94305 | United States |
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| University of Cincinnati San Diego | Recruiting | San Diego | California | 92121 | United States |
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| Swedish Medical Center | Recruiting | Englewood | Colorado | 80113 | United States |
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| Hartford Health Hospital | Recruiting | Hartford | Connecticut | 06106 | United States |
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| Yale University | Recruiting | New Haven | Connecticut | 06510 | United States |
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| University of Miami | Recruiting | Miami | Florida | 33125 | United States |
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| Emory University | Recruiting | Atlanta | Georgia | 30322 | United States |
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| University of Chicago | Recruiting | Chicago | Illinois | 60637 | United States |
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| University of Louisville | Recruiting | Louisville | Kentucky | 40202 | United States |
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| Boston Medical Center | Recruiting | Boston | Massachusetts | 02118 | United States |
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| Barnes Jewish Hospital | Recruiting | Saint Loius | Missouri | 63110 | United States |
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| New York University | Recruiting | Brooklyn | New York | 11220 | United States |
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| Icahn School of Medicine at Mount Sinai | Recruiting | New York | New York | 10029 | United States |
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| Columbia University | Recruiting | New York | New York | 10032 | United States |
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| University of Cincinnati Medical Center | Recruiting | Cincinnati | Ohio | 45219 | United States |
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| Providence St. Vincent Medical Center | Recruiting | Portland | Oregon | 97225 | United States |
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| University of Pittsburgh Medical Center | Recruiting | Pittsburgh | Pennsylvania | 15213 | United States |
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| Baptist Memorial Hospital | Recruiting | Memphis | Tennessee | 38120 | United States |
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| Vanderbilt University Medical Center | Recruiting | Nashville | Tennessee | 37232 | United States |
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| University of Texas at Austin | Recruiting | Austin | Texas | 78712 | United States |
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| University of Washington | Recruiting | Seattle | Washington | 98104 | United States |
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| West Virginia University | Recruiting | Morgantown | West Virginia | 26506 | United States |
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| ID | Term |
|---|---|
| D020521 | Stroke |
| D000083242 | Ischemic Stroke |
| ID | Term |
|---|---|
| D002561 | Cerebrovascular Disorders |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
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| ID | Term |
|---|---|
| D011216 | Practice Management, Medical |
| ID | Term |
|---|---|
| D020399 | Practice Management |
| D011364 | Professional Practice |
| D009934 | Organization and Administration |
| D006298 | Health Services Administration |
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