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Blood Pressure Variability and Ischemic Stroke Outcome

Study acronym: BP-VISO
StatusRecruiting
PhaseNot specified
Started2024-07-15
View on ClinicalTrials.gov ↗
Trial flagged as At Risk
Primary completion moved at least 11 months later Jul 30, 2026 → Jul 15, 2027
See other at-risk trials from Yale University

Amendment history

2026-09-29
critical
Primary completion pushed: 2026-07-30 → 2027-07-15
Completion pushed: 2026-07-30 → 2027-07-15
2026-05-18
minor
Study Status v11
Primary completion date2026-03-30→2026-07-30
Completion date2026-03-30→2026-07-30
2025-06-29
minor
Study Status, Study Description, Outcome Measures, Eligibility v10
Eligibility criteriarevised
[...] resonance angiography (MRA) Onset of ischemic stroke within 2448 hours and able to get baseline pMRI within 72 hours of arri [...]
Study descriptionrevised
[...] nterior circulation stroke and a baseline NIH Stroke Scale ≥64 within 2448 hours of AIS onset at three study sites. With completion of [...]
2024-07-19
minor
Study Status v9
Start dateestimated 2024-07→confirmed 2024-07-15
2024-07-12
notable
Not Yet Recruiting→Recruiting Study Status, Contacts/Locations v8
Trial statusNot Yet Recruiting→Recruiting
Start date2024-05→2024-07
Study sitesdetails revised at 3 of 3 sites
Show 7 earlier versions
2024-05-09
minor
Study Status v7
Re-verified, no change to tracked fields
2024-04-08
minor
Study Status v6
Start date2024-02→2024-05
2024-01-30
minor
Study Identification, Study Status, Sponsor/Collaborators, Outcome Measures, Eligibility, IPDSharing v5
Completion date2028-03-30→2026-03-30
Start date2024-01-01→2024-02
Eligibility criteria+52 characters
[...] angiography (MRA) Onset of ischemic stroke within 24 hours and able to get baseline pMRI within 72 hours of onsetarrival 4) NIH Stroke Scale ≥6 4 at time of enrollment Exclusion Criteria: Pre-morbid mRS ≥3 [...]
Secondary endpoints4 to 9 entries
RecurrentIncidence of stroke RecurrentIncidence of stroke Change in Montreal Cognitive declineAssessment scale (MoCA-BLIND) to assess post-stroke cognition CognitiveChange declinein Oral Trails A and B Test to assess post-stroke cognition Change in Category Fluency tests to assess post-stroke cognition Change in Patient Health Questionnaire (PHQ-9) to assess mood Change in General Anxiety Disorder-7 (GAD-7) to assess mood Change in Lawton Instrumental Activities of Daily Liv [...]
Collaborators2 to 3 entries
National Institute of Neurological Disorders and Stroke (NINDS)
2023-11-28
minor
Study Status v4
Start date2023-11-01→2024-01-01
2023-09-06
minor
Study Status v3
Start date2023-07-01→2023-11-01
2023-04-20
minor
Study Status v2
Start date2023-04-01→2023-07-01
2023-03-20
minor
Study Status, Study Description, Outcome Measures v1
Secondary endpointsdetails revised at 2 of 4 entries
Study description+44 characters
[...] retrospective analyses, independent of mean blood pressure. OurThe investigators' central hypothesis is that increased BPV is harmful after A [...] ntihypertensive medications on BPV. To achieve these goals, wethe study will enroll 150 patients who have anterior circulation stro [...] IS onset at three study sites. With completion of the Aims, wethe study will define the outcome for a future trial, the effect size [...] ge of healthcare settings. By completing the proposed aims, wethe investigators will be ideally positioned to test accessible targeted interventions to diminish the morbidity and mortality of AIS.
2023-02-22
minor
Original filing
487 trials monitored
See 35 trials at risk
3,268 trials monitored
See 122 trials at risk
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.
Trial Details
NCT Number NCT05756257
Lead Sponsor Yale University
Collaborators: University of Chicago, Massachusetts General Hospital, National Institute of Neurological Disorders and Stroke (NINDS)
Conditions Acute Ischemic Stroke, Blood Pressure Variability
Enrollment 150 participants
Start Date 2024-07-15
Primary Completion 2027-07-15 (estimated)
Study Completion 2027-07-15 (estimated)
Updated on ClinicalTrials.gov 2026-09-28