Blood Pressure Variability and Ischemic Stroke Outcome

Last updated: May 18, 2026
Sponsor: Yale University
Overall Status: Active - Recruiting

Phase

N/A

Condition

Stroke

Blood Clots

Thrombosis

Treatment

N/A

Clinical Study ID

NCT05756257
Pro00065750
1R01NS130189-01
2000034922
  • Ages > 18
  • All Genders

Study Summary

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

Inclusion

Inclusion Criteria:

  • Ischemic stroke according to the American Heart Association (AHA) definition andeither:
  1. CT or MRI showing ischemic stroke in the anterior circulation (frontal,parietal or superior temporal lobes), or

  2. Occlusion of the internal carotid, middle cerebral or anterior cerebralarteries on computed tomography angiography (CTA) or magnetic resonanceangiography (MRA)Onset of ischemic stroke within 48 hours and able to get baseline pMRI within 72 hours of arrival

  1. NIH Stroke Scale ≥ 4 at time of enrollment

Exclusion

Exclusion Criteria:

  • Pre-morbid mRS ≥3

  • Predicted hospital system admission <72 hours

  • Pacemaker or other MRI contraindications per American College of Radiologyguidelines

Study Design

Total Participants: 150
Study Start date:
July 15, 2024
Estimated Completion Date:
July 30, 2026

Study Description

Increased blood pressure variability (BPV) has consistently been associated with two to three times higher risk of disability or mortality after acute ischemic stroke (AIS) in retrospective analyses, independent of mean blood pressure. The investigators' central hypothesis is that increased BPV is harmful after AIS and warrants reduction. However, prior BPV research in AIS patients has been retrospective and limited by non-standardized BP measurement and, therefore, BPV is not mentioned in current stroke guidelines. To address the limitations of prior BPV research, determine mechanisms of BPV's deleterious effect, and identify potentially effective methods to reduce BPV, the proposed study will: 1) prospectively validate that "short-term" and "long-term" BPV after AIS onset is associated with functional outcome and define the effect size of different levels of BPV, 2) utilize portable MRI to confirm that final infarct volume is mechanistically related to BPV, and 3) utilize bedside pupillometry to determine how the autonomic nervous system contributes to BPV after AIS and evaluate the class effect of antihypertensive medications on BPV. To achieve these goals, the study will enroll 150 patients who have anterior circulation stroke and a baseline NIH Stroke Scale ≥4 within 48 hours of AIS onset at three study sites. With completion of the Aims, the study will define the outcome for a future trial, the effect size of BPV on individual outcomes and composites, the duration for lowering BPV (24-72 hours vs. weeks or months), and potential interventions to reduce BPV. Pharmacologic BPV reduction would be an inexpensive and widely available intervention, able to be administered in a range of healthcare settings. By completing the proposed aims, the investigators will be ideally positioned to test accessible targeted interventions to diminish the morbidity and mortality of AIS.

Connect with a study center

  • Yale-New Haven Hospital

    New Haven, Connecticut 06510
    United States

    Active - Recruiting

  • University of Chicago Medical Center

    Chicago, Illinois 60637
    United States

    Active - Recruiting

  • Massachusetts General Hospital

    Boston, Massachusetts 02114
    United States

    Active - Recruiting

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