Recruiting

Observational Study

Sponsor:

Yale University

Code:

NCT05756257

Conditions

Acute Ischemic Stroke

Blood Pressure Variability

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Study Details

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. 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.

Conditions

Acute Ischemic Stroke

Blood Pressure Variability

Study ID

NCT05756257

Start date

Jul 15, 2024

Status verified date

May, 2026

Completion date

Jul 30, 2026

Anticipated

Primary completion date

Jul 30, 2026

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Inclusion Criteria:

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

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 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

4\) NIH Stroke Scale ≥ 4 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

Study Design

Enrollment

150 participants

Anticipated

Interventions and Outcome Measures

Arms

Acute Ischemic Stroke

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

Primary outcome measure

  • Change in Functional outcome [ Time Frame: 90 days and 1 Year ]
  • Imaging outcome [ Time Frame: 72 hours +/- 60 hours ]

Central Contacts and Locations

Central contacts

Adam de Havenon, MD

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

Locations

Yale-New Haven Hospital

Recruiting

New Haven, Connecticut, United States, 06510

Contacts

Alison Champagne, MD

alison.champagne@yale.edu

Principal Investigator:

Adam de Havenon, MD

University of Chicago Medical Center

Recruiting

Chicago, Illinois, United States, 60637

Massachusetts General Hospital

Recruiting

Boston, Massachusetts, United States, 02114

More Information

Sponsor

Yale University

Last update posted

May 20, 2026

Last verified

May, 2026

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-08. This information was provided to ClinicalTrials.gov by Yale University on 2026-05-20.