Ischemic Stroke, AcuteCOMPASSNCT07903922
Continuous Blood Pressure Variability and Small Vessel Disease in Acute Ischemic Stroke
An observational study of Ischemic Stroke, Acute and Blood Pressure Variability, run by Minyoul Baik at 1 site in South Korea.
Trial 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. Read more about this study
- Who is it for?
- Ages 19 years and older
- Conditions the study is for
- Ischemic Stroke, Acute, Blood Pressure Variability, Cerebral Small Vessel Disease
- What is being tested?
- Cuffless ring-type continuous blood pressure monitor
- Type of treatment
- Medical device
- How many people
- 450 participants
- Where
- 1 siteSouth Korea
- Study dates
- Oct 2026to Sep 2029
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 19 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
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.
Who may be able to join
- 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)
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
South Korea1 site
Yongin Severance Hospital, Yonsei University College of Medicine
Yongin, Gyeonggi-do, 16995
About this study
Official title: 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.
Read more
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.
Read the 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.
- Conditions
- Ischemic Stroke, Acute, Blood Pressure Variability, Cerebral Small Vessel Disease, White Matter Hyperintensity
- Being tested
- Cuffless ring-type continuous blood pressure monitor
- Keywords
- blood pressure variability, nocturnal blood pressure, non-dipping, cuffless blood pressure, wearable device, photoplethysmography, continuous blood pressure monitoring, white matter hyperintensity, cerebral small vessel disease, cerebral autoregulation, functional outcome, modified Rankin Scale, prognosis
- Medical subject headings
- Ischemic Stroke, Cerebral Small Vessel Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Cuffless ring-type continuous blood pressure monitorDevice
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.
| Study group | Role | What they receive |
|---|---|---|
| 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). Receives: Device: Cuffless ring-type continuous blood pressure monitor |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: At discharge or transfer from the neurology service, whichever occurs first (an average of 7 days)
Secondary outcomes (4)
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 90 days after stroke onset
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Oct 2026
- Study startOct 2026 (estimated)
- Primary completionJun 2029 (estimated)
- Study completionSep 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Ischemic Stroke, AcuteStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 450 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Minyoul Baik
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Minyoul Baik, Yonsei University
- Investigators
- Minyoul Baik, MD, Principal investigator, Yongin Severance Hospital, Yonsei University College of Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07903922
- Sponsor's protocol ID
- COMPASS-9-2026-0184
- Other IDs
- RS-2026-25581947
- Acronym
- COMPASS
- Status last verified
- Oct 2026
- First submitted
- 13 Oct 2026
- Last updated
- 29 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: There is no current plan to share individual participant data. Data sharing may be reconsidered in accordance with institutional policy and journal requirements.
Study at a glance
From the registry record, last updated by the sponsor on 29 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Continuous Outcome Modeling by Pressure Variability and Small Vessel Status in Acute Ischemic Stroke: A Prospective Observational Cohort Study (COMPASS)
- ClinicalTrials.gov ID
- NCT07903922
- Acronym / sponsor ID
- COMPASS / COMPASS-9-2026-0184
- Conditions
- Ischemic Stroke, Acute, Blood Pressure Variability, Cerebral Small Vessel Disease, White Matter Hyperintensity
- Keywords
- blood pressure variability, nocturnal blood pressure, non-dipping, cuffless blood pressure, wearable device, photoplethysmography, continuous blood pressure monitoring, white matter hyperintensity
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 450 participants (estimated)
- Lead sponsor
- Minyoul BaikUniversity, hospital or other
- Study start
- Oct 2026 (estimated)
- Primary completion
- Jun 2029 (estimated)
- Study completion
- Sep 2029 (estimated)
- First posted
- 29 Oct 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Acute ischemic stroke with 72-hour continuous BP monitoring | – | Device: Cuffless ring-type continuous blood pressure monitorAdults 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). |
Who may qualify
- Ages
- 19 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (3 listed)
- 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)
Key exclusion criteria (4 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Cuffless ring-type continuous blood pressure monitorA 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. | Device | Acute ischemic stroke with 72-hour continuous BP monitoring |
Primary outcome
Poor functional outcome (modified Rankin Scale 3-6) at discharge
Time frame: 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.
4 secondary outcomes
Ordinal modified Rankin Scale at the end of admission
Time frame: At discharge or transfer from the neurology service, whichever occurs first (an average of 7 days)
Early neurological deterioration during hospitalization
Time frame: During the acute neurology admission (an average of 7 days)
Parenchymal hematoma during hospitalization
Time frame: During the acute neurology admission (an average of 7 days)
Poor functional outcome (modified Rankin Scale 3-6) at 3 months
Time frame: 90 days after stroke onset
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Oct 2026.
- Individual participant dataSharing planned: No. 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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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Minyoul Baik, MD principal investigator
Yongin Severance Hospital, Yonsei University College of Medicine
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Ischemic Stroke, Acute and Blood Pressure Variability, run by Minyoul Baik at 1 site in South Korea.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 29 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in South Korea. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Minyoul Baik, MD (+82-31-5189-8160, minyoulbaik@yuhs.ac), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Poor functional outcome (modified Rankin Scale 3-6) at discharge (time frame: At discharge or transfer from the neurology service, whichever occurs first (an average of 7 days)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Oct 2026.