Blood Pressure Clinical Trial
— DETECTOfficial title:
Blood Pressure Management in Stroke Following Endovascular Treatment
Verified date | November 2023 |
Source | Hamilton Health Sciences Corporation |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
The aim of DETECT is to prove the feasibility of a multicenter phase III trial testing the hypothesis that intensive blood pressure control immediately after successful endovascular stroke thrombectomy can improve patient outcomes. Patients with stroke who have ongoing high blood pressure after successful clot retrieval will be included. Participants will be randomly placed (like flipping a coin) in one of two groups. There will be a 50% chance of each patient being placed to either group. The first group will be allowed to have a higher blood pressure range that is consistent with current recommendations. The second group will be given medications to bring their blood pressure down into a normal range. These blood pressure targets will be maintained for 48 hours. We will collect patient brain images and levels of stroke disability up to 90 days after their clot retrieval.
Status | Completed |
Enrollment | 30 |
Est. completion date | May 4, 2023 |
Est. primary completion date | February 4, 2023 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility | Inclusion Criteria: - Age equal or more than 18 years. - Eligible for endovascular treatment (EVT) within 24 hours from symptom onset according to current clinical practice. - Presence of a proximal large vessel occlusion in the anterior circulation, defined as occlusion of the intracranial segment of the internal carotid artery and/or occlusion of the M1 segment or proximal M2 segment of the middle cerebral artery. - Successful recanalization after the end of the EVT procedure, defined as modified thrombolysis in cerebral ischemia (mTICI) score equal or more than 2b. - Sustained elevated systolic BP level after recanalization, defined as 2 consecutive systolic BP readings = 150 mmHg (or = 140 mmHg if the participant has a known history of hypertension) taken more than 5 minutes apart. - Ability of the patient or legal representative to provide informed consent. - Randomization within 60 minutes from the end of the EVT procedure. Exclusion Criteria: - Presence of concomitant ipsilateral or contralateral extracranial vessel occlusion or remaining stenosis =80% after the end of the EVT. - Symptomatic intracranial hemorrhage after the end of EVT procedure. - Any medical condition where randomization to either standard or intensive BP lowering would not be acceptable at the discretion of the investigators and/or the treating physician. - Pregnancy. - Enrollment in another acute stroke therapeutic trial. |
Country | Name | City | State |
---|---|---|---|
Canada | Hamilton General Hospital | Hamilton | Ontario |
Lead Sponsor | Collaborator |
---|---|
Hamilton Health Sciences Corporation |
Canada,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Other | Absolute difference in mean systolic blood pressure values. | Difference in mean systolic blood pressure values between the two arms. | 48 hours from treatment initiation | |
Other | Number of participants with symptomatic intracranial hemorrhage. | According to the Safe Implementation of Thrombolysis in Stroke-Monitoring Study (SITS-MOST), National Institute of Neurological Disorders and Stroke (NINDS) and European-Australian Cooperative Acute Stroke Study 2 (ECASS 2) definitions. | 24±12 hours from treatment initiation | |
Other | Number of deaths during hospitalization. | All-cause in-hospital mortality. | Day 7 from treatment initiation or hospital discharge | |
Other | Number of deaths during follow-up. | All-cause mortality. | Day 90±10 from treatment initiation | |
Other | Number of participants with neurological deterioration. | Defined as =4 points decline in the National Institute of Health Stroke Scale (NIHSS) from randomization or death. | 24 hours from treatment initiation | |
Other | Functional outcome during hospitalization. | Ordinal shift analysis of the full range of category scores (0-6) of the modified Rankin Scale (mRS). | Day 7 from treatment initiation or hospital discharge | |
Other | Functional outcome during follow-up. | Ordinal shift analysis of the full range of category scores (0-6) of the modified Rankin Scale (mRS). | Day 90±10 from treatment initiation | |
Other | Number of participants with favorable functional outcomes during hospitalization. | Favorable functional outcomes defined as modified Rankin Scale (mRS) scores of 0-1 or 0-2. | Day 7 from treatment initiation or hospital discharge | |
Other | Number of participants with favorable functional outcomes during follow-up | Favorable functional outcomes defined as modified Rankin Scale (mRS) scores of 0-1 or 0-2. | Day 90±10 from treatment initiation | |
Other | Absolute difference in the decline of the Alberta stroke program early CT scores. | The Alberta Stroke Program Early CT Score (ASPECTS) is a 10-point (range 0-10) quantitative topographic imaging scale with higher scores indicating more favorable imaging profiles. Differences will be assessed between the baseline and repeat computed tomography scan. | 24±12 hours from treatment initiation | |
Other | Absolute difference in final infarct volumes. | As assessed in the magnetic resonance imaging (MRI) scan, when available. | Day 7 from treatment initiation | |
Other | Absolute difference in hospital stay. | Duration of hospital length of stay in days. | Day 7 from treatment initiation or hospital discharge | |
Primary | Mean enrollment rate. | The predefined target is to achieve a mean enrollment rate of 2 patients per month. | through study completion, an average of 18 months | |
Primary | Number of participants with treatment allocation change. | The predefined target is that at least 80% of the participants remain within their assigned treatment group, and not changing treatment allocation for any reason. | 48 hours from treatment initiation | |
Secondary | Number of participants with any intracranial hemorrhage. | As identified in the follow-up computed tomography scan. | 24±12 hours from treatment initiation | |
Secondary | Absolute difference in flow velocity measurements in transcranial Doppler. | Assessed with the adjusted mean flow velocities of the recanalized vessel on transcranial Doppler examination. | 0-18 hours from treatment initiation | |
Secondary | Absolute difference in the NIH Stroke Scale change at day 1. | NIH Stroke Scale ranges from 0 to 42, with higher scores indicating more severe impairment caused by a stroke. | 24±12 hours from treatment initiation | |
Secondary | Absolute difference in the NIH Stroke Scale change at day 2. | NIH Stroke Scale ranges from 0 to 42, with higher scores indicating more severe impairment caused by a stroke. | 48±12 hours from treatment initiation |
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