BP-VISO: Blood Pressure Variability and Ischemic Stroke Outcome

Sponsor

Yale University (Other)

Overall Status

Not yet recruiting

CT.gov ID

NCT05756257

Collaborator

University of Chicago (Other), Massachusetts General Hospital (Other)

150

Enrollment

Locations

Anticipated Duration (Months)

Patients Per Site

0.8

Patients Per Site Per Month

Study Details

Study Description

Brief 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:

To determine the association of BPV with functional/cognitive outcome after ischemic stroke.
To determine a pathophysiologic mechanism of BPV's deleterious effect on functional outcome.
To evaluate potential treatment targets to pharmacologically reduce BPV after ischemic stroke.

Condition or Disease	Intervention/Treatment	Phase
Acute Ischemic Stroke Blood Pressure Variability

Detailed 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. Our 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, we will enroll 150 patients who have anterior circulation stroke and a baseline NIH Stroke Scale ≥6 within 24 hours of AIS onset at three study sites. With completion of the Aims, we 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, we will be ideally positioned to test accessible targeted interventions to diminish the morbidity and mortality of AIS.

Study Design

Study Type:

Observational

Anticipated Enrollment :

150 participants

Observational Model:

Cohort

Time Perspective:

Prospective

Official Title:

Blood Pressure Variability and Ischemic Stroke Outcome

Anticipated Study Start Date :

Apr 1, 2023

Anticipated Primary Completion Date :

Mar 30, 2026

Anticipated Study Completion Date :

Mar 30, 2028

Arms and Interventions

Arm	Intervention/Treatment
Acute Ischemic Stroke Blood pressure variability will be measured in the patients with acute ischemic stroke.

Outcome Measures

Primary Outcome Measures

Change in Functional outcome [90 days and 1 Year]
Modified Rankin Scale, the scale uses a range of range is 0-6 where higher scores indicate increased function.
Imaging outcome [72 hours]
Final infarct volume at 72 hours

Secondary Outcome Measures

Recurrent stroke [90 days]
Recurrent ischemic stroke
Recurrent stroke [1 year]
Recurrent ischemic stroke
Cognitive decline [90 days]
Cognitive testing will provide measurement of cognitive decline.
Cognitive decline [1 year]
Cognitive testing will provide measurement of cognitive decline.

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Inclusion Criteria:

Ischemic stroke according to the American Heart Association (AHA) definition and either:

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)

Onset of ischemic stroke within 24 hours of onset
NIH Stroke Scale ≥6 at time of enrollment

Exclusion Criteria:

Pre-morbid mRS ≥3
Predicted hospital system admission <72 hours
Pacemaker or other MRI contraindications per American College of Radiology guidelines

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Yale-New Haven Hospital	New Haven	Connecticut	United States	06510
2	University of Chicago Medical Center	Chicago	Illinois	United States	60637
3	Massachusetts General Hospital	Boston	Massachusetts	United States	02114

Sponsors and Collaborators

Yale University
University of Chicago
Massachusetts General Hospital

Investigators

Principal Investigator: Adam de Havenon, MD, Yale University

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Yale University

ClinicalTrials.gov Identifier:

NCT05756257

Other Study ID Numbers:

Pro00065750

First Posted:

Mar 6, 2023

Last Update Posted:

Mar 6, 2023

Last Verified:

Feb 1, 2023

Individual Participant Data (IPD) Sharing Statement:

Undecided

Plan to Share IPD:

Undecided

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Additional relevant MeSH terms:

Study Results

No Results Posted as of Mar 6, 2023