Continuous Blood Pressure Variability and Small Vessel Disease in Acute Ischemic Stroke
COMPASS
Continuous Outcome Modeling by Pressure Variability and Small Vessel Status in Acute Ischemic Stroke: A Prospective Observational Cohort Study (COMPASS)
COMPASS
Continuous Outcome Modeling by Pressure Variability and Small Vessel Status in Acute Ischemic Stroke: A Prospective Observational Cohort Study (COMPASS)
Sponsor study identifier
Secondary identifiers
OTHER_GRANT · National Research Foundation of Korea
observational
450
1 country
1
Study Start
October 2026
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
Primary Completion
June 2029
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
Study Completion
September 2029
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
This prospective observational cohort study examines whether blood pressure variability and nighttime blood pressure patterns, measured non-invasively over 72 hours with a cuffless ring-type wearable device, help predict recovery in patients with acute ischemic stroke. In acute ischemic stroke, how much blood pressure fluctuates - and whether it drops normally during sleep - may affect brain injury and outcome. Standard cuff monitors measure blood pressure only intermittently and can disturb sleep, which limits assessment of these patterns. This study uses a finger-worn cuffless continuous monitor to capture blood pressure without disturbing sleep. The study also examines whether the burden of pre-existing cerebral small vessel disease, seen as white matter changes on brain MRI, changes how strongly blood pressure variability relates to outcome. Blood pressure data are collected for research analysis only and are not used to guide treatment. All clinical care follows standard stroke guidelines, regardless of study participation. The main outcome is functional recovery (modified Rankin Scale) at hospital discharge.
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
September 2029
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
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Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
October 2026
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
October 13, 2026
Actual (reported)October 29, 2026
Actual (reported)June 2029
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
September 2029
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
Poor functional outcome (modified Rankin Scale 3-6) at discharge
Functional outcome measured by the modified Rankin Scale (mRS), a 7-level scale from 0 (no symptoms) to 6 (death). Poor outcome is defined as mRS 3-6 versus good outcome mRS 0-2, assessed at hospital discharge. The primary analysis relates this outcome to systolic blood pressure variability (standard deviation) over the first 72 hours.
At discharge or transfer from the neurology service, whichever occurs first (an average of 7 days)
Ordinal modified Rankin Scale at the end of admission
At discharge or transfer from the neurology service, whichever occurs first (an average of 7 days)
Early neurological deterioration during hospitalization
Adults with acute ischemic stroke presenting within 24 hours of onset who undergo up to 72 hours of cuffless continuous blood pressure monitoring with a ring-type wearable device. Analyzed as a single cohort with blood pressure variability as a continuous exposure; a prespecified subgroup is defined by white matter hyperintensity severity (Fazekas total \>=3 vs \<3).
A cuffless, photoplethysmography-based ring-type wearable device worn on a finger records blood pressure continuously for up to 72 hours after admission for acute ischemic stroke. It is used solely for observational research data collection and does not guide clinical treatment; blood pressure management follows standard care regardless of the device readings. Blood pressure variability metrics derived from these recordings are the exposure of interest.
Adults with acute ischemic stroke presenting within 24 hours of symptom onset and admitted to a single stroke center. Patients with atrial fibrillation are excluded because it degrades the accuracy of photoplethysmography-based blood pressure estimation.
Yongin Severance Hospital, Yonsei University College of Medicine
Yongin, Gyeonggi-do, 16995, South Korea
Minyoul Baik, MD
Yongin Severance Hospital, Yonsei University College of Medicine
First Submitted
October 13, 2026
First Posted
October 29, 2026
Study Start
October 2026
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
Primary Completion
CompARing Between CO2 Phenylephrine and Phenylephrine Only Treatment in Patients With proGrEssing Cerebral infarctioN
During the acute neurology admission (an average of 7 days)
Parenchymal hematoma during hospitalization
During the acute neurology admission (an average of 7 days)
Poor functional outcome (modified Rankin Scale 3-6) at 3 months
90 days after stroke onset
Contact the study team to confirm eligibility.
June 2029
Planned date reported by the registry; this milestone is not confirmed as achieved.
Study Completion
September 2029
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
Last Updated
October 29, 2026
Record last verified: 2026-10
There is no current plan to share individual participant data. Data sharing may be reconsidered in accordance with institutional policy and journal requirements.
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Source: ClinicalTrials.gov.
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