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NOT YET RECRUITING
NCT07903922

Continuous Blood Pressure Variability and Small Vessel Disease in Acute Ischemic Stroke

Sponsor: Minyoul Baik

View on ClinicalTrials.gov

Summary

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.

Official title: Continuous Outcome Modeling by Pressure Variability and Small Vessel Status in Acute Ischemic Stroke: A Prospective Observational Cohort Study (COMPASS)

Key Details

Gender

All

Age Range

19 Years - Any

Study Type

OBSERVATIONAL

Enrollment

450

Start Date

2026-10

Completion Date

2029-09

Last Updated

2026-10-29

Healthy Volunteers

No

Interventions

DEVICE

Cuffless ring-type continuous blood pressure monitor

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.

Locations (1)

Yongin Severance Hospital, Yonsei University College of Medicine

Yongin, Gyeonggi-do, South Korea