Evaluating blood pressure variability in acute ischemic stroke patients
Blood Pressure Variability and Ischemic Stroke Outcome
This study is testing how changes in blood pressure affect recovery and thinking skills in people who have had an acute ischemic stroke.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 150 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Yale University Academic / other |
| Locations | 3 sites (New Haven, Connecticut and 2 other locations) |
| Trial ID | NCT05756257 on ClinicalTrials.gov |
What this trial studies
This observational study aims to assess the impact of blood pressure variability (BPV) on functional and cognitive outcomes in patients who have experienced an acute ischemic stroke. It will investigate the association between BPV and patient outcomes, explore the underlying mechanisms of BPV's negative effects, and identify potential pharmacological treatments to reduce BPV. The study will enroll 150 patients with anterior circulation strokes and utilize advanced imaging techniques to validate findings and understand the relationship between BPV and stroke severity.
Who should consider this trial
Good fit: Ideal candidates for this study are patients who have suffered an acute ischemic stroke within the last 24 hours and have a baseline NIH Stroke Scale score of 4 or higher.
Not a fit: Patients with pre-existing severe disability or those who are not expected to remain hospitalized for at least 72 hours may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to improved treatment strategies for managing blood pressure variability in stroke patients, potentially enhancing recovery outcomes.
How similar studies have performed: Previous studies have indicated a correlation between blood pressure variability and adverse outcomes in stroke patients, but this study aims to provide a more standardized and prospective evaluation of this relationship.
Eligibility criteria
Show full inclusion / exclusion criteria
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
Where this trial is running
New Haven, Connecticut and 2 other locations
- Yale-New Haven Hospital — New Haven, Connecticut, United States (Recruiting)
- University of Chicago Medical Center — Chicago, Illinois, United States (Recruiting)
- Massachusetts General Hospital — Boston, Massachusetts, United States (Recruiting)
Study contacts
- Principal investigator: Adam de Havenon, MD — Yale University
- Study coordinator: Adam de Havenon, MD
- Email: adam.dehavenon@yale.edu
- Phone: 203-785-4085
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.