Clinical trial NCT05756257: Blood Pressure Variability and Ischemic Stroke Outcome
Official title: Blood Pressure Variability and Ischemic Stroke Outcome
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Acute Ischemic Stroke
Blood Pressure Variability
Lead sponsor: Yale University
Sponsor class: OTHER
Collaborators: name: University of Chicago
name: Massachusetts General Hospital
name: National Institute of Neurological Disorders and Stroke (NINDS)
First posted: 2023-03-06
Enrollment: 150
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
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.

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.

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. 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 ≥6 within 24 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.

Eligibility 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 24 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

Primary outcomes:
measure: Change in Functional outcome
timeFrame: 90 days and 1 Year
measure: Imaging outcome
timeFrame: 72 hours
Secondary outcomes:
measure: Incidence of stroke
timeFrame: 90 days
measure: Incidence of stroke
timeFrame: 1 year
measure: Change in Montreal Cognitive Assessment scale (MoCA-BLIND) to assess post-stroke cognition
timeFrame: 3 days and 1 year
measure: Change in Oral Trails A and B Test to assess post-stroke cognition
timeFrame: 3 days and 1 year
measure: Change in Category Fluency tests to assess post-stroke cognition
timeFrame: 3 days and 1 year
measure: Change in Patient Health Questionnaire (PHQ-9) to assess mood
timeFrame: 3 days and 1 year
measure: Change in General Anxiety Disorder-7 (GAD-7) to assess mood
timeFrame: 3 days and 1 year
measure: Change in Lawton Instrumental Activities of Daily Living (IADL) Scale to assess adaptive functioning
timeFrame: 3 days and 1 year
measure: Change in Katz Index of Independence in Activities of Daily Living (ADL) to assess adaptive functioning
timeFrame: 3 days and 1 year
Other outcomes:
Locations:
city: New Haven
country: United States
facility: Yale-New Haven Hospital
state: Connecticut
city: Chicago
country: United States
facility: University of Chicago Medical Center
state: Illinois
city: Boston
country: United States
facility: Massachusetts General Hospital
state: Massachusetts
Study officials:
affiliation: Yale University
name: Adam de Havenon, MD
role: PRINCIPAL_INVESTIGATOR
References: