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)

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.

Study Overview

• Status: Recruiting
• Conditions: Cerebral Small Vessel Disease; Ischemic Stroke, Acute; White Matter Hyperintensity; Blood Pressure Variability
• Intervention / Treatment: Device: Cuffless ring-type continuous blood pressure monitor

Detailed Description

Design and population: This is a single-center, prospective, observational cohort study. Adults (>=19 years) with acute ischemic stroke presenting within 24 hours of symptom onset are enrolled. Patients with atrial fibrillation are excluded because it degrades the accuracy of photoplethysmography (PPG)-based blood pressure estimation. A total of 450 participants are planned over three years.

Blood pressure monitoring: As soon as possible after enrollment, a cuffless, PPG-based ring-type wearable device is applied to a finger and records blood pressure continuously for up to 72 hours without disturbing sleep. Wearing the device does not interfere with standard care, and blood pressure management follows standard clinical guidelines. The device data are used for research analysis only and do not guide real-time treatment.

Imaging: Baseline white matter hyperintensity (WMH) is graded on MRI FLAIR using the Fazekas scale (total 0-6), with severe WMH defined as a total score of 3 or higher.

Exposures: The primary exposure is systolic blood pressure variability over the first 72 hours (primary metric: standard deviation of systolic blood pressure). Secondary exposures include the coefficient of variation and maximum-minimum difference of systolic and diastolic blood pressure, and the nocturnal dipping pattern (dipper, non-dipper, reverse-dipper).

Outcome: The primary outcome is poor functional outcome, defined as a modified Rankin Scale score of 3-6, assessed at hospital discharge.

Hypotheses: (1) Increased systolic blood pressure variability and a nocturnal non-dipping pattern independently predict poor functional outcome at discharge. (2) Severe WMH amplifies the association between blood pressure variability and poor outcome (synergistic effect).

Statistical analysis: The primary analysis uses multivariable logistic regression relating systolic blood pressure variability (standard deviation) to poor outcome (mRS 3-6), adjusted for mean blood pressure, age, sex, baseline comorbidities, and initial NIHSS. Incremental model performance is assessed by AUC, net reclassification improvement (NRI), and integrated discrimination improvement (IDI).

A prespecified interaction analysis tests effect modification by severe WMH (blood pressure variability x severe WMH; P for interaction), with subgroup analysis by WMH severity (Fazekas >=3 vs <3).

Prespecified secondary analyses re-examine the primary finding using alternative variability metrics and the nocturnal dipping pattern.

Prespecified exploratory analyses include nonlinear dose-response modeling of blood pressure variability and mean blood pressure using restricted cubic splines, including spline curves stratified by WMH severity. Analyses beyond those prespecified are reported as exploratory.

• Study Type: Observational
• Enrollment (Estimated): 450

Contacts and Locations

• Study Contact: Name: Minyoul Baik, MD; Phone Number: +82-31-5189-8160; Email: minyoulbaik@yuhs.ac

Study Locations

• South Korea
  • Gyeonggi-do
    • Yongin, Gyeonggi-do, South Korea, 16995
      • Recruiting
      • Yongin Severance Hospital, Yonsei University College of Medicine
      • Contact: Minyoul Baik; Email: minyoulbaik@yuhs.ac

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 19 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

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.

Description

Inclusion Criteria:

• Adults aged 19 years or older
• Acute ischemic stroke confirmed on diagnostic imaging, presenting within 24 hours of symptom onset
• Written informed consent from the patient or, if the patient is temporarily unable to consent, a legally authorized representative (with patient re-consent upon recovery)

Exclusion Criteria:

• Atrial fibrillation or other arrhythmia that degrades the accuracy of photoplethysmography-based blood pressure estimation
• Finger condition unsuitable for device wear (injury, edema, circulatory compromise, or amputation)
• Short life expectancy or imminent death making 72-hour observation inappropriate
• Other conditions deemed unsuitable for the study by the investigator

Study Plan

How is the study designed?

Design Details

• Observational Models: COHORT
• Time Perspectives: PROSPECTIVE

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort

Intervention / Treatment

Acute ischemic stroke with 72-hour continuous BP monitoring; 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).

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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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)

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Ordinal modified Rankin Scale at the end of admission	Full distribution of the modified Rankin Scale (0-6) at the end of the acute neurology admission, analyzed in relation to blood pressure variability metrics.	At discharge or transfer from the neurology service, whichever occurs first (an average of 7 days)
Early neurological deterioration during hospitalization	Early neurological deterioration, defined as an increase of 2 or more points in the NIHSS during the acute admission.	During the acute neurology admission (an average of 7 days)
Parenchymal hematoma during hospitalization	Parenchymal hematoma on follow-up imaging, classified by the ECASS radiologic criteria (PH1 or PH2), during the acute neurology admission.	During the acute neurology admission (an average of 7 days)
Poor functional outcome (modified Rankin Scale 3-6) at 3 months	Functional outcome is measured by the modified Rankin Scale (mRS), a 7-level scale ranging from 0 (no symptoms) to 6 (death). A poor outcome is defined as an mRS score of 3-6, compared to a good outcome of 0-2, evaluated at 3 months post-stroke if follow-up data are available.	90 days after stroke onset

Collaborators and Investigators

• Sponsor: Minyoul Baik
• Investigators: Principal Investigator: Minyoul Baik, MD, Yongin Severance Hospital, Yonsei University College of Medicine

Study record dates

Study Major Dates

• Study Start (Actual): November 6, 2026
• Primary Completion (Estimated): June 1, 2029
• Study Completion (Estimated): September 1, 2029

Study Registration Dates

• First Submitted: October 13, 2026
• First Submitted That Met QC Criteria: October 22, 2026
• First Posted (Actual): October 29, 2026

Study Record Updates

• Last Update Posted (Actual): November 12, 2026
• Last Update Submitted That Met QC Criteria: November 6, 2026
• Last Verified: November 1, 2026

More Information

Terms related to this study

• Keywords: prognosis; functional outcome; cerebral small vessel disease; cerebral autoregulation; modified Rankin Scale; photoplethysmography; wearable device; blood pressure variability; white matter hyperintensity; nocturnal blood pressure; non-dipping; cuffless blood pressure; continuous blood pressure monitoring
• Additional Relevant MeSH Terms: Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases; Stroke; Ischemic Stroke; Cerebral Small Vessel Diseases
• Other Study ID Numbers: COMPASS-9-2026-0184; RS-2026-25581947 (Other Grant/Funding Number: National Research Foundation of Korea)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

IPD Plan Description

There is no current plan to share individual participant data. Data sharing may be reconsidered in accordance with institutional policy and journal requirements.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No