Prevention and Control of Hypertension: JACC Health Promotion Series.
Robert M Carey, Paul Muntner, Hayden B Bosworth...
https://pubmed.ncbi.nlm.nih.gov/30190007Actively Recruiting
Phase Not Applicable
Age: 18Years - 80Years
All Genders
Healthy Volunteers
ID06513975
Validation Study of CART BP as a Wearable Cuffless Blood Pressure Monitor: Evaluation of Blood Pressure Measurement by Height and Physical Activity
Led by Sky Labs · Updated on 2025-06-15
50
Participants Needed
1
Research Sites
N/A
Total Duration
On this page
Sponsors
S
Sky Labs
Lead Sponsor
S
Samsung Medical Center
Collaborating Sponsor
AI-Summary
What this Trial Is About
Researchers are evaluating the accuracy of the CART BP, a wearable cuffless blood pressure monitor, compared to the traditional auscultatory method using a dual-head stethoscope. This study follows the 2023 European Society of Hypertension recommendations and focuses on patients with suspected high or low blood pressure. The evaluation looks at measurements taken in different body positions and during various exercise activities. Participants prescribed a 24-hour ambulatory blood pressure monitor will use both the CART BP ring device and a standard sphygmomanometer simultaneously to measure blood pressure and pulse rate. The study includes measurements with the arm positioned significantly lower than usual and after repeated handgrip exercises to assess changes in blood pressure accuracy under different conditions. During the study, participants will have their blood pressure monitored continuously over a one-hour period, and researchers will measure the mean error and variability between the CART BP and the traditional method. Participants must comply with the study protocol and provide consent, with monitoring including exercise tests and posture changes. The total participation duration and follow-up details are consistent with the 24-hour blood pressure monitoring period.
CONDITIONS
Brief Title
Validation Study of CART BP as a Wearable Cuffless Blood Pressure Monitor
Who Can Participate
Age: 18Years - 80Years
All Genders
Healthy Volunteers
Eligibility Criteria
You may qualify if you...
- Subjects aged 18 years or older but younger than 80 years
- Individuals who voluntarily decide to participate in this clinical trial and provide written consent to the information and consent form
- Individuals willing to comply with the clinical trial protocol
You will not qualify if you...
- Subjects who do not consent to the study
- Obese individuals with a Body Mass Index (BMI) of 30 or higher (concerns about measurement errors as the standard 24-hour ambulatory blood pressure monitor cuff may not fit the arm properly)
- Patients or volunteers who are pregnant
- Patients or volunteers with underlying heart diseases: those with a history of hospitalization for heart failure, valvular disease, or myocardial infarction
- Patients or volunteers diagnosed with atrial fibrillation on a 12-lead electrocardiogram (ECG) within the past 6 months
- Patients or volunteers with end-stage renal disease (undergoing dialysis)
- Patients or volunteers unable to perform repeated exercises required for the study
- Patients or volunteers with a systolic blood pressure (SBP) exceeding 160 millimeters of mercury (mmHg)
- Patients or volunteers with a systolic blood pressure (SBP) exceeding 160 millimeters of mercury (mmHg) and/or a diastolic blood pressure (DBP) exceeding 100 millimeters of mercury (mmHg) (for exercise tests)
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
1
2
3
Your Study Journey
Screening
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Diagnostic Evaluation
Duration - Approximately 24 hours
Participants undergo blood pressure measurement using both the CART BP wearable device and a sphygmomanometer, following the 2023 European Society of Hypertension recommendations, including measurements at different arm positions and after physical exercises.
1 visit with 24-hour monitoring
Long-term Monitoring
Duration - 24 hours
Participants are observed during the 24-hour ambulatory blood pressure monitoring period using both devices to compare measurement accuracy.
Continuous monitoring over 24 hours
Trial Site Locations
Total: 1 location
1
Samsung Medical Center
Seoul, South Korea
Actively Recruiting
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Research Team
G
Gerrard Kim
Y
Yujung Kang
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
DIAGNOSTIC
Number of Arms
1
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Published Research Related To This Trial
European Society of Hypertension recommendations for the validation of cuffless blood pressure measuring devices: European Society of Hypertension Working Group on Blood Pressure Monitoring and Cardiovascular Variability.
George S Stergiou, Alberto P Avolio, Paolo Palatini...
https://pubmed.ncbi.nlm.nih.gov/37303198Expert panel consensus recommendations for ambulatory blood pressure monitoring in Asia: The HOPE Asia Network.
Kazuomi Kario, Jinho Shin, Chen-Huan Chen...
https://pubmed.ncbi.nlm.nih.gov/31532913European Society of Hypertension position paper on ambulatory blood pressure monitoring.
Eoin O'Brien, Gianfranco Parati, George Stergiou...
https://pubmed.ncbi.nlm.nih.gov/24029863