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

6 november 2026 bijgewerkt door: Minyoul Baik

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.

Studie Overzicht

Toestand

Werving

Conditie

Interventie / Behandeling

Gedetailleerde beschrijving

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.

Studietype

Observationeel

Inschrijving (Geschat)

450

Contacten en locaties

In dit gedeelte vindt u de contactgegevens van degenen die het onderzoek uitvoeren en informatie over waar dit onderzoek wordt uitgevoerd.

Studiecontact

Studie Locaties

  • Zuid -Korea
    • Gyeonggi-do
      • Yongin, Gyeonggi-do, Zuid -Korea, 16995
        • Werving
        • Yongin Severance Hospital, Yonsei University College of Medicine
        • Contact:

Deelname Criteria

Onderzoekers zoeken naar mensen die aan een bepaalde beschrijving voldoen, de zogenaamde geschiktheidscriteria. Enkele voorbeelden van deze criteria zijn iemands algemene gezondheidstoestand of eerdere behandelingen.

Geschiktheidscriteria

Leeftijden die in aanmerking komen voor studie

19 jaar en ouder (Volwassen, Oudere volwassene)

Accepteert gezonde vrijwilligers

Nee

Geslachten die in aanmerking komen voor studie

Allemaal

Bemonsteringsmethode

Niet-waarschijnlijkheidssteekproef

Studie Bevolking

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.

Beschrijving

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

Studie plan

Dit gedeelte bevat details van het studieplan, inclusief hoe de studie is opgezet en wat de studie meet.

Hoe is de studie opgezet?

Ontwerpdetails

  • Observatiemodellen: COHORT
  • Tijdsperspectieven: PROSPECTIVE

Cohorten en interventies

Groep / Cohort
Interventie / Behandeling
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).
Apparaat: 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.

Wat meet het onderzoek?

Primaire uitkomstmaten

Uitkomstmaat
Maatregel Beschrijving
Tijdsspanne
Poor functional outcome (modified Rankin Scale 3-6) at discharge
Tijdsspanne: At discharge or transfer from the neurology service, whichever occurs first (an average of 7 days)

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)

Secundaire uitkomstmaten

Uitkomstmaat
Maatregel Beschrijving
Tijdsspanne
Ordinal modified Rankin Scale at the end of admission
Tijdsspanne: At discharge or transfer from the neurology service, whichever occurs first (an average of 7 days)

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
Tijdsspanne: During the acute neurology admission (an average of 7 days)

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
Tijdsspanne: During the acute neurology admission (an average of 7 days)

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
Tijdsspanne: 90 days after stroke onset

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

Medewerkers en onderzoekers

Hier vindt u mensen en organisaties die betrokken zijn bij dit onderzoek.

Sponsor

Minyoul Baik

Onderzoekers

  • Hoofdonderzoeker: Minyoul Baik, MD, Yongin Severance Hospital, Yonsei University College of Medicine

Studie record data

Deze datums volgen de voortgang van het onderzoeksdossier en de samenvatting van de ingediende resultaten bij ClinicalTrials.gov. Studieverslagen en gerapporteerde resultaten worden beoordeeld door de National Library of Medicine (NLM) om er zeker van te zijn dat ze voldoen aan specifieke kwaliteitscontrolenormen voordat ze op de openbare website worden geplaatst.

Bestudeer belangrijke data

Studie start (Werkelijk)

6 november 2026

Primaire voltooiing (Geschat)

1 juni 2029

Studie voltooiing (Geschat)

1 september 2029

Studieregistratiedata

Eerst ingediend

13 oktober 2026

Eerst ingediend dat voldeed aan de QC-criteria

22 oktober 2026

Eerst geplaatst (Werkelijk)

29 oktober 2026

Updates van studierecords

Laatste update geplaatst (Werkelijk)

12 november 2026

Laatste update ingediend die voldeed aan QC-criteria

6 november 2026

Laatst geverifieerd

1 november 2026

Meer informatie

Termen gerelateerd aan deze studie

Trefwoorden

Aanvullende relevante MeSH-voorwaarden

Andere studie-ID-nummers

  • COMPASS-9-2026-0184
  • RS-2026-25581947 (Ander subsidie-/financieringsnummer: National Research Foundation of Korea)

Plan Individuele Deelnemersgegevens (IPD)

Bent u van plan om gegevens van individuele deelnemers (IPD) te delen?

NEE

Beschrijving IPD-plan

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

Informatie over medicijnen en apparaten, studiedocumenten

Bestudeert een door de Amerikaanse FDA gereguleerd geneesmiddel

Nee

Bestudeert een door de Amerikaanse FDA gereguleerd apparaatproduct

Nee

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