Blood Pressure Variability and Ischemic Stroke Outcome

NCT05756257 | Recruiting

• 3 other identifiers: Pro0006575020000349221R01NS130189-01
• Study Type: observational
• Target: 150
• Locations: 1 country
• Sites: 3

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:

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

Conditions

Acute Ischemic Stroke; Blood Pressure Variability

Outcome Measures

Primary Outcomes (2)

• Change in Functional outcome

  Modified Rankin Scale, the scale uses a range of 0-6 where higher scores indicate decreased function.

  90 days and 1 Year

• Imaging outcome

  Final infarct volume on MRI at 72 hours

  72 hours +/- 60 hours

Secondary Outcomes (9)

• Incidence of stroke

  90 days

• Incidence of stroke

  1 year

• Change in Montreal Cognitive Assessment scale (MoCA-BLIND) to assess post-stroke cognition

  3 days and 1 year

• Change in Oral Trails A and B Test to assess post-stroke cognition

  3 days and 1 year

• Change in Category Fluency tests to assess post-stroke cognition

  3 days and 1 year

Study Arms (1)

Acute Ischemic Stroke

Blood pressure variability will be measured in the patients with acute ischemic stroke.

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients with acute ischemic stroke serve as the source population for the study and will be identified as inpatients at participating centers.

You may qualify if:

• 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 48 hours and able to get baseline pMRI within 72 hours of arrival
• \) NIH Stroke Scale ≥ 4 at time of enrollment

You may not qualify if:

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

Sponsors & Collaborators

• Yale University: lead
• University of Chicago: collaborator
• Massachusetts General Hospital: collaborator
• National Institute of Neurological Disorders and Stroke (NINDS): collaborator

Study Sites (3)

Yale-New Haven Hospital

New Haven, Connecticut, 06510, United States

RECRUITING

University of Chicago Medical Center

Chicago, Illinois, 60637, United States

RECRUITING

Massachusetts General Hospital

Boston, Massachusetts, 02114, United States

RECRUITING

MeSH Terms

Conditions

Ischemic Stroke

Condition Hierarchy (Ancestors)

Stroke; Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases

Study Officials

• Adam de Havenon, MD

  Yale University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Adam de Havenon, MD

CONTACT

203-785-4085; adam.dehavenon@yale.edu

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 15, 2023
• First Posted: March 6, 2023
• Study Start: July 15, 2024
• Primary Completion: March 30, 2026
• Study Completion: March 30, 2026
• Last Updated: July 3, 2025

Record last verified: 2025-06

Data Sharing

• IPD Sharing: Will not share

Locations

US (3)