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Treatment With Endovascular Intervention for STroke Patients With Existing Disability (TESTED)

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ClinicalTrials.gov Identifier: NCT05911568
Recruitment Status : Recruiting
First Posted : June 22, 2023
Last Update Posted : November 28, 2023
Sponsor:
Collaborators:
Patient-Centered Outcomes Research Institute
University of California, Los Angeles
Icahn School of Medicine at Mount Sinai
Information provided by (Responsible Party):
Eva A. Mistry, University of Cincinnati

Brief Summary:
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.

Condition or disease Intervention/treatment
Stroke Stroke, Acute Stroke, Ischemic Procedure: Endovascular Stroke Treatment Other: Medical Management

Detailed Description:

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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Study Type : Observational
Estimated Enrollment : 1060 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Treatment With Endovascular Intervention for STroke Patients With Existing Disability
Actual Study Start Date : November 16, 2023
Estimated Primary Completion Date : January 15, 2028
Estimated Study Completion Date : April 15, 2028

Resource links provided by the National Library of Medicine


Group/Cohort Intervention/treatment
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
Procedure: Endovascular Stroke Treatment
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

Other: Medical Management
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.




Primary Outcome Measures :
  1. modified Rankin Scale (mRS) [ Time Frame: 90 (±14) days after treatment initiation ]
    Score of 0-3, 4, 5 or 6 on the modified Rankin Scale (mRS) (Note: mRS range: 0 (no residual symptoms) to 6 (death)


Secondary Outcome Measures :
  1. Disability-weighted (or utility-weighted) mRS [ Time Frame: 90 (±14) days after treatment initiation ]
    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

  2. Return to the pre-stroke mRS level [ Time Frame: 90 (±14) days after treatment initiation ]
    Returning to the pre-stroke mRS level post stroke

  3. EQ-5D-5L [ Time Frame: 90 (±14) days after treatment initiation ]
    Quality of life assessment scale with range: 0 (worst health) to 100 (best health)

  4. Academic Medical Center - Linear Disability Scale (ALDS) [ Time Frame: 90 (±14) days after treatment initiation ]
    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.


Other Outcome Measures:
  1. modified Rankin Scale (mRS) [ Time Frame: At hospital discharge ]
    Score of 0-3, 4, 5 or 6 on the modified Rankin Scale (mRS) (Note: mRS range: 0 (no residual symptoms) to 6 (death)

  2. Montreal Cognitive Assessment (MoCA) [ Time Frame: 90 (±14) days after treatment initiation ]
    Montreal Cognitive Assessment (MoCA) (Note: MoCA range: 0-30, higher scores mean better outcome)

  3. Barthel Index Scale [ Time Frame: 90 (±14) days after treatment initiation ]
    Barthel Index range: 0-100, higher scores mean participant is independent

  4. Initial residence level or better time during first 90 days post-stroke [ Time Frame: 90 days after treatment initiation ]
    Number of days spend at the initial residence level or better during the first 90 days post-stroke

  5. Zarit's Burden Interview (ZBI) [ Time Frame: 90 (±14) days after treatment initiation ]
    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.

  6. Extended Thrombolysis in Cerebral Ischemia scale [ Time Frame: At the end of EVT procedure ]
    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

  7. Death [ Time Frame: 90 (±14) after treatment initiation ]
  8. Symptomatic intracranial hemorrhage [ Time Frame: 24 (±6) hours ]
    Evaluate modified Heidelberg definition



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
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.
Criteria

Inclusion Criteria:

  1. Adult patients (≥18 years)
  2. Moderate-to-severe pre-stroke functional disability, defined as mRS 3-4, for at least 3 months prior to stroke onset
  3. Presenting to study hospital within 24 hours of last known well time
  4. Diagnosis of acute ischemic stroke
  5. Intracranial causative occlusion of the internal carotid artery or the M1 or dominant M2 segments of the middle cerebral artery visualized on the baseline CT(or MR) angiogram
  6. Presenting CT Alberta Stroke Program Early CT (ASPECT) score ≥3 or MRI ASPECT score ≥4
  7. Presenting NIH Stroke Scale score ≥6
  8. Informed consent from patient if competent or from legally authorized representative

Exclusion Criteria:

  1. Known diagnosis of a terminal cancer or terminal illness at the time of stroke
  2. Assessment of pre-stroke functional status cannot be performed during the hospital stay
  3. Pre-stroke disability deemed temporary in the investigator's opinion (for example, recovering from a general medical illness or traumatic bodily injury)

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05911568


Contacts
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Contact: Eva Mistry, MD 513-558-1291 mistryea@ucmail.uc.edu
Contact: Naima Griffin 513-558-0125 griffna@ucmail.uc.edu

Locations
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United States, Arizona
HonorHealth Not yet recruiting
Phoenix, Arizona, United States, 85013
Contact: Ashu Jadhav, MD         
Principal Investigator: Ashu Jadhav, MD         
United States, California
University of California at Los Angeles Not yet recruiting
Los Angeles, California, United States, 90095
Contact: Jeffrey Saver, MD         
Principal Investigator: Jeffrey Saver, MD         
United States, Connecticut
Hartford Health Hospital Not yet recruiting
Hartford, Connecticut, United States, 06106
Contact: Tapan Mehta, MD         
Principal Investigator: Tapan Mehta, MD         
Yale University Not yet recruiting
New Haven, Connecticut, United States, 06510
Contact: Adam DeHavenon, MD         
Principal Investigator: Adam DeHavenon, MD         
United States, Florida
University of Miami Not yet recruiting
Miami, Florida, United States, 33125
Contact: Robert Starke, MD         
Principal Investigator: Robert Starke, MD         
United States, New York
Icahn School of Medicine at Mount Sinai Not yet recruiting
New York, New York, United States, 10029
Contact: J Mocco, MD         
Principal Investigator: J Mocco, MD         
Columbia University Not yet recruiting
New York, New York, United States, 10032
Contact: Joshua Wiley, MD         
Principal Investigator: Joshua Wiley, MD         
United States, Ohio
University of Cincinnati Medical Center Recruiting
Cincinnati, Ohio, United States, 45219
Contact: Stacie Demel, DO, PhD         
Principal Investigator: Stacie Demel, DO, PhD         
United States, Pennsylvania
University of Pittsburgh Medical Center Not yet recruiting
Pittsburgh, Pennsylvania, United States, 15213
Contact: Raul Nogueira, MD         
Principal Investigator: Raul Nogueira, MD         
United States, Tennessee
Vanderbilt University Medical Center Not yet recruiting
Nashville, Tennessee, United States, 37232
Contact: Michael Froehler, MD         
Principal Investigator: Michael Froehler, MD         
United States, Washington
University of Washington Not yet recruiting
Seattle, Washington, United States, 98104
Contact: David Tirschwell, MD         
Principal Investigator: David Tirschwell, MD         
United States, West Virginia
West Virginia University Not yet recruiting
Morgantown, West Virginia, United States, 26506
Contact: Ansaar Rai, MD         
Principal Investigator: Ansaar Rai, MD         
Sponsors and Collaborators
University of Cincinnati
Patient-Centered Outcomes Research Institute
University of California, Los Angeles
Icahn School of Medicine at Mount Sinai
Investigators
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Principal Investigator: Eva Mistry, MD University of Cincinnati
Principal Investigator: Jeffrey Saver, MD Ronald Reagan UCLA Medical Center
Principal Investigator: J Mocco, MD Icahn School of Medicine at Mount Sinai
Principal Investigator: Heidi Sucharew, PhD University of Cincinnati
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Responsible Party: Eva A. Mistry, Assistant Professor, University of Cincinnati
ClinicalTrials.gov Identifier: NCT05911568    
Other Study ID Numbers: 2023-0299
First Posted: June 22, 2023    Key Record Dates
Last Update Posted: November 28, 2023
Last Verified: November 2023
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Supporting Materials: Study Protocol
Statistical Analysis Plan (SAP)
Informed Consent Form (ICF)
Time Frame: One year after completing of the final analysis

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Stroke
Ischemic Stroke
Cerebrovascular Disorders
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Vascular Diseases
Cardiovascular Diseases