Blood Pressure Variability and Ischemic Stroke Outcome
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorYale University
About this trial
The goal of this observational study is to evaluate the role of blood pressure (BPV) variability in patients suffering from acute ischemic stroke. The main questions it aims to answer are:
1. To determine the association of BPV with functional/cognitive outcome after ischemic stroke. 2. To determine a pathophysiologic mechanism of BPV's deleterious effect on functional outcome. 3. To evaluate potential treatment targets to pharmacologically reduce BPV after ischemic stroke.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
CT or MRI showing ischemic stroke in the anterior circulation (frontal, parietal or superior temporal lobes), or
Occlusion of the internal carotid, middle cerebral or anterior cerebral arteries on computed tomography angiography (CTA) or magnetic resonance angiography (MRA)
Disqualifiers
Pre-morbid mRS ≥3
Predicted hospital system admission <72 hours
Pacemaker or other MRI contraindications per American College of Radiology guidelines
Trial population
Patients with acute ischemic stroke serve as the source population for the study and will be identified as inpatients at participating centers.
Trial design
Design model
Cohort
Time perspective
Prospective
Treatments tested in this trial
Not listed
Trial groups
150 Participants
are grouped into 1 trial groupGroup A: Acute Ischemic Stroke
Trial outcomes
Primary outcomes
1
Change in Functional outcome
Modified Rankin Scale, the scale uses a range of 0-6 where higher scores indicate decreased function.
Time frame
90 days and 1 Year2
Imaging outcome
Final infarct volume on MRI at 72 hours
Time frame
72 hours +/- 60 hoursSecondary outcomes
1
Incidence of stroke
Incidence of new (recurrent) ischemic stroke
Time frame
90 days2
Incidence of stroke
Incidence of new (recurrent) ischemic stroke
Time frame
1 year3
Change in Montreal Cognitive Assessment scale (MoCA-BLIND) to assess post-stroke cognition
Post-stroke cognition will be assessed using the MoCA-BLIND, The MoCA-BLIND assess six different cognitive domains (excludes visual stimulus) over the phone: memory, attention, language, abstraction, delayed recall, and orientation. The MoCA-BLIND is scored from 0-22. Lower scores indicate less cognitive impairment.
Time frame
3 days and 1 year4
Change in Oral Trails A and B Test to assess post-stroke cognition
Post-stroke cognition will be assessed using the Oral Trails A and B Test to measure psychomotor speed, visual search, and attention. The test is scored based on how many seconds it takes to complete each part. Higher scores indicate a higher degree of cognitive impairment.
Time frame
3 days and 1 yearSponsors and contacts
Click on the lead sponsor to view all of their trials.
Yale University
Lead sponsor
University of Chicago
Collaborator
Massachusetts General Hospital
Collaborator
National Institute of Neurological Disorders and Stroke (NINDS)
Collaborator
Source ClinicalTrials.gov