An observational study in Ischemic Stroke, Acute, Blood Pressure Variability and Cerebral Small Vessel Disease, sponsored by Minyoul Baik. Not yet recruiting at 1 site in South Korea. Open to participants aged 19 Years and older. Per ClinicalTrials.gov, last updated 2026-10-29.
Sponsored by Minyoul Baik · Observational
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.
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.
2,612 studies on the registry are indexed under Ischemic Stroke; 971 are open to participants now.
This study's planned enrollment of 450 is above the median of 300 across 771 observational studies indexed under Ischemic Stroke.
Browse Ischemic Stroke studies →This is the only study on the registry with Minyoul Baik as lead sponsor.
Counted across the registry records on this site, refreshed daily.
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.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
The study doctor’s estimate of how long someone is likely to live. Criteria use it so that people can stay in the study long enough for it to answer its question.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Life expectancy
The study doctor’s estimate of how long someone is likely to live. Criteria use it so that people can stay in the study long enough for it to answer its question.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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.
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.
Time frame: 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
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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 90 days after stroke onset
Plan to share: No — There is no current plan to share individual participant data. Data sharing may be reconsidered in accordance with institutional policy and journal requirements.
No publications or documents are linked to this record.
Start is estimated for Oct 2026; primary completion for Jun 2029, 32 months later.
Of 394 non-industry observational studies under Ischemic Stroke, half reached primary completion within 56 months of starting (the median), counting those still running; a quarter within 25 and three quarters within 140. This study's planned 32 months is below that.
Counting every sponsor, half of 436 studies reached it within 53 months; a quarter within 24 and three quarters within 127.
How these figures are worked out, and which studies are left out of them.
From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗
This study is not yet recruiting, as verified in Oct 2026. You cannot join it, but the record below documents what was studied.
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