Acute Stroke Clinical Trial
— BEST-IIOfficial title:
Blood Pressure After Endovascular Stroke Therapy-II: A Randomized Trial
Verified date | September 2023 |
Source | University of Cincinnati |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
The purpose of this study is to assess the safety of lowering blood pressure in acute stroke patients that are successfully treated with a mechanical thrombectomy procedure. The investogators will evaluate the hypothesis that lower blood pressure management strategies do not result in larger volume of stroke or worse 3-month clinical outcome in these patients.
Status | Completed |
Enrollment | 120 |
Est. completion date | December 15, 2022 |
Est. primary completion date | July 1, 2022 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility | Inclusion Criteria: - Adult patients (=18 years) - Undergoing successful EVT (defined as modified Thrombolysis in Cerebral Ischemia Score, mTICI, =2b) for an occlusion in the anterior cerebral circulation large vessel (internal carotid artery and M1 or M2 segments of the middle cerebral artery). - Intervention will be initiated only for those with a successful recanalization (modified Thrombolysis in Cerebral Ischemia Score = 2b). - Undergoing a baseline CT or MR perfusion study - Those with unsuccessful recanalization (mTICI 0-2a) will be not intervened upon. Exclusion Criteria: - Known heart failure with ejection fraction <30% - Presence of a left ventricular assist device - Patients undergoing extracorporeal membrane oxygenation - Pregnancy - Enrollment in any other clinical trial |
Country | Name | City | State |
---|---|---|---|
United States | University of Cincinnati | Cincinnati | Ohio |
United States | Hartford Healthcare | Hartford | Connecticut |
United States | Vanderbilt University Medical Center | Nashville | Tennessee |
Lead Sponsor | Collaborator |
---|---|
University of Cincinnati | National Institute of Neurological Disorders and Stroke (NINDS), Vanderbilt University Medical Center |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Other | Compliance Outcome | Number of participants with an hourly maximum SBP above target from 2-24 hrs post treatment initiation | Treatment initiation to 24 hrs after treatment Initiation | |
Primary | Final Infarct Volume | Infarct volume on diffusion-weighted MRI (or CT if MRI cannot be obtained) at 36 (+/-12) hrs after treatment initiation, adjusted for the baseline CT perfusion core infract volume. | 36 (+/-12) hrs after treatment initiation | |
Primary | Utility-weighted Modified Rankin Score | Modified Rankin score (mRS) is a scale for measuring the degree of disability or dependence of people who have suffered a stroke. 0 - no symptoms at all; 1 - no significant disability despite symptoms; able to carry out all usual duties and activities; 2- slight disability; unable to carry out all previous activities, but able to look after own affairs without assistance; 3- moderate disability; requiring some help, but able to walk without assistance; 4 - moderately severe disability; unable to walk without assistance and unable to attend to own bodily needs without assistance; 5 - severe disability; bedridden, incontinent and requiring constant nursing care and attention; 6- dead.
Patient centered utility weights are applied to these scores as 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. Unlike the mRS, the utility-weighted mRS runs from 0 to 1, with 0 being the worst. |
90 days after treatment initiation | |
Secondary | Number of Participants With Any Hemorrhagic Transformation | Number of participants with any new bleeding within the infarcted brain tissue on 36(+/-12) hr MRI/CT scan after treatment initiation | 36(+/-12) hrs after treatment initiation | |
Secondary | Number of Participants With Symptomatic Hemorrhagic Transformation | Defined as number of participants with any new bleeding within the infarcted brain tissue and an NIH Stroke Scale worsening of 4 or more points associated with the bleeding within 36 (+/-12) hrs of treatment initiation | 36(+/-12) hrs after treatment initiation | |
Secondary | Number of Participants With Neurological Worsening Associated With Antihypertensive Treatment | Defined as number of participants with 4 points of greater increase in NIH Stroke scale associated with reduction in SBP caused by anti-hypertensive treatment initiation or titration. | Treatment initiation to 24 hrs after treatment initiation |
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