Acute Ischemic StrokeBP-VISONCT05756257
Blood Pressure Variability and Ischemic Stroke Outcome
An observational study of Acute Ischemic Stroke and Blood Pressure Variability, run by Yale University at 3 sites in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Acute Ischemic Stroke, Blood Pressure Variability
- How many people
- 150 participants
- Where
- 3 sitesUnited States
- Study dates
- 15 Jul 2024to 15 Jul 2027
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients with acute ischemic stroke serve as the source population for the study and will be identified as inpatients at participating centers.
Who may be able to join
- 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
- 4) NIH Stroke Scale ≥ 4 at time of enrollment
Who cannot join
- Pre-morbid mRS ≥3
- Predicted hospital system admission <72 hours
- Pacemaker or other MRI contraindications per American College of Radiology guidelines
Trial locations and contacts
3 sites in 1 country. Contact the study team or a site near you to ask about taking part.
United States3 sites, 3 recruiting
- Recruiting
Massachusetts General Hospital
Boston, Massachusetts, 02114
W. Taylor Kimberly, MD, PhD
- Recruiting
University of Chicago Medical Center
Chicago, Illinois, 60637
Shyam Prabhakaran, MD
- Recruiting
Yale-New Haven Hospital
New Haven, Connecticut, 06510
Alison Champagne, MD, alison.champagne@yale.edu
Adam de Havenon, MD
About this study
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.
Read the 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 ≥4 within 48 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.
- Conditions
- Acute Ischemic Stroke, Blood Pressure Variability
- Medical subject headings
- Ischemic Stroke
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Acute Ischemic Stroke | Blood pressure variability will be measured in the patients with acute ischemic stroke. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Functional outcome
Modified Rankin Scale, the scale uses a range of 0-6 where higher scores indicate decreased function.
Measured: 90 days and 1 Year
Imaging outcome
Final infarct volume on MRI at 72 hours
Measured: 72 hours +/- 60 hours
Secondary outcomes (9)
Incidence of stroke
Incidence of new (recurrent) ischemic stroke
Measured: 90 days
Incidence of stroke
Incidence of new (recurrent) ischemic stroke
Measured: 1 year
Change in Montreal Cognitive Assessment scale (MoCA-BLIND) to assess post-stroke cognition
Post-stroke cognition will be assessed using the MoCA-BLIND, The MoCA-BLIND assess six different cognitive domains (excludes visual stimulus) over the phone: memory, attention, language, abstraction, delayed recall, and orientation. The MoCA-BLIND is scored from 0-22. Lower scores indicate less cognitive impairment.
Measured: 3 days and 1 year
Change in Oral Trails A and B Test to assess post-stroke cognition
Post-stroke cognition will be assessed using the Oral Trails A and B Test to measure psychomotor speed, visual search, and attention. The test is scored based on how many seconds it takes to complete each part. Higher scores indicate a higher degree of cognitive impairment.
Measured: 3 days and 1 year
Change in Category Fluency tests to assess post-stroke cognition
Categorical verbal fluency tests (CFT) are used to assess the integrity of semantic memory in individuals with brain damage. Participants are given 1 min to produce as many unique words as possible within a semantic category (category fluency) or starting with a given letter (letter fluency). The participant's score in each task is the number of unique correct words.
Measured: 3 days and 1 year
Change in Patient Health Questionnaire (PHQ-9) to assess mood
Nine items asking about the frequency of specific depressive symptoms experienced. The response options are scored from 0 to 3, indicating "not at all" to "nearly every day." The total score on the PHQ-9 ranges from 0 to 27, with higher scores indicating greater severity of depressive symptoms. The scoring can also be divided into categories, with scores of 0-4 indicating minimal or no depression, 5-9 indicating mild depression, 10-14 indicating moderate depression, 15-19 indicating moderately severe depression, and 20-27 indicating severe depression.
Measured: 3 days and 1 year
Change in General Anxiety Disorder-7 (GAD-7) to assess mood
General Anxiety Disorder- 7 (GAD-7) is a 7 item self report instrument that measures anxiety Items are scored on a 4-point scale, ranging from "not at all (0)" to "nearly everyday (3)". Item scores are summed with a total score ranging from 0 to 21: 0-4 Minimal anxiety; 5-9 Mild anxiety; 10-14 Moderate anxiety; 15-21 Severe anxiety.
Measured: 3 days and 1 year
Change in Lawton Instrumental Activities of Daily Living (IADL) Scale to assess adaptive functioning
The IADL assesses a person's ability to perform tasks such as using a telephone, doing laundry, and handling finances. It consists of 8 items and total score is achieve by summing all items. Each item is scored 0 = less able or 1 = more able. Total score range is from 0 (low function, dependent) to 8 (high function, independent) for women and 0 through 5 for men to avoid potential gender bias. The higher the score, the greater the person's abilities.
Measured: 3 days and 1 year
Change in Katz Index of Independence in Activities of Daily Living (ADL) to assess adaptive functioning
The Katz IADL assesses the patient's need for assistance in performing basic activities of daily living. Total scores range from 0-12, with higher scores indicating better levels of functioning.
Measured: 3 days and 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Mar 2023
- Study start15 Jul 2024
- Primary completion15 Jul 2027 (estimated)
- Study completion15 Jul 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Acute Ischemic StrokeStudies of the same condition, open and under way.
- More trials run by Yale UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 150 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Yale University
- Sponsor type
- University, hospital or other
- Collaborators
- University of Chicago, Massachusetts General Hospital, National Institute of Neurological Disorders and Stroke (NINDS)
- Responsible party
- Sponsor
- Investigators
- Adam de Havenon, MD, Principal investigator, Yale University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05756257
- Sponsor's protocol ID
- Pro00065750
- Other IDs
- 2000034922, 1R01NS130189-01
- Acronym
- BP-VISO
- Status last verified
- Sep 2026
- First submitted
- 15 Feb 2023
- Last updated
- 28 Sep 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Blood Pressure Variability and Ischemic Stroke Outcome
- ClinicalTrials.gov ID
- NCT05756257
- Acronym / sponsor ID
- BP-VISO / Pro00065750
- Conditions
- Acute Ischemic Stroke, Blood Pressure Variability
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 150 participants (estimated)
- Lead sponsor
- Yale UniversityUniversity, hospital or other
- Collaborators
- University of Chicago, Massachusetts General Hospital, National Institute of Neurological Disorders and Stroke (NINDS)
- Study start
- 15 Jul 2024 (actual)
- Primary completion
- 15 Jul 2027 (estimated)
- Study completion
- 15 Jul 2027 (estimated)
- First posted
- 6 Mar 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 ≥4 within 48 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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Acute Ischemic Stroke | – | –Blood pressure variability will be measured in the patients with acute ischemic stroke. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients with acute ischemic stroke serve as the source population for the study and will be identified as inpatients at participating centers.
Key inclusion criteria (5 listed)
- Ischemic stroke according to the American Heart Association (AHA) definition and either:
- 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
Key exclusion criteria (3 listed)
- Pre-morbid mRS ≥3
- Predicted hospital system admission <72 hours
- Pacemaker or other MRI contraindications per American College of Radiology guidelines
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Change in Functional outcome
Time frame: 90 days and 1 Year
Modified Rankin Scale, the scale uses a range of 0-6 where higher scores indicate decreased function.
Imaging outcome
Time frame: 72 hours +/- 60 hours
Final infarct volume on MRI at 72 hours
9 secondary outcomes
Incidence of stroke
Time frame: 90 days
Incidence of stroke
Time frame: 1 year
Change in Montreal Cognitive Assessment scale (MoCA-BLIND) to assess post-stroke cognition
Time frame: 3 days and 1 year
Change in Oral Trails A and B Test to assess post-stroke cognition
Time frame: 3 days and 1 year
Change in Category Fluency tests to assess post-stroke cognition
Time frame: 3 days and 1 year
Change in Patient Health Questionnaire (PHQ-9) to assess mood
Time frame: 3 days and 1 year
Change in General Anxiety Disorder-7 (GAD-7) to assess mood
Time frame: 3 days and 1 year
Change in Lawton Instrumental Activities of Daily Living (IADL) Scale to assess adaptive functioning
Time frame: 3 days and 1 year
Change in Katz Index of Independence in Activities of Daily Living (ADL) to assess adaptive functioning
Time frame: 3 days and 1 year
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Sep 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Adam de Havenon, MD principal investigator
Yale University
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Acute Ischemic Stroke and Blood Pressure Variability, run by Yale University at 3 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 28 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Adam de Havenon, MD (203-785-4085, adam.dehavenon@yale.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Functional outcome (time frame: 90 days and 1 Year). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Sep 2026.