Validation Study of CART BP as a Wearable Cuffless Blood Pressure Monitor

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

50 participants

Study Classification

INTERVENTIONAL

Study Start Date

2024-11-22

Study Completion Date

2025-08-15

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

This study aims to evaluate the accuracy of the CART BP, a medically approved ring-type blood pressure monitor, in comparison to the traditional auscultatory method using a dual-head stethoscope. The comparison is conducted in accordance with the 2023 European Society of Hypertension (ESH) Recommendations, focusing on patients with suspected hypertension or hypotension. The evaluation includes accuracy measurements across various postures and during different exercise periods.

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

Pivotal Clinical Trial to Evaluate the Blood Pressure Accuracy of 'CART-I Plus'

NCT05725148

Blood Pressure Hypertension Hypotension

COMPLETED NA

Feasibility and Effectiveness of a Ring-type Blood Pressure Measurement Device

NCT06084065

Hypertension Blood Pressure Systolic Hypertension +4 more

UNKNOWN NA

Wrist Worn Blood Pressure Measurement

NCT03919136

Blood Pressure Heart Failure Advanced Heart Failure +1 more

UNKNOWN

Clinical Calibration & Validation of a Next-Generation Blood Pressure Monitor for Patient Management

NCT03015363

Hypertension

COMPLETED

Optical System to Continuously Measure Arterial Blood Pressure

NCT02651558

Blood Pressure

COMPLETED NA

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

There is a non-invasive technique called Photoplethysmography (PPG) that overcomes the limitations of traditional auscultatory and oscillometric methods. Photoplethysmography uses light-emitting diodes (LEDs) to illuminate human tissue, specifically targeting blood vessels, and employs sensors to measure the volume of blood flowing through the tissue. This technique can be applied to various parts of the small arterial system in the human body, enabling cuffless blood pressure measurement. As a result, it simplifies blood pressure monitoring for subjects and allows for extended observation periods.

With the advancement of cuffless blood pressure monitors, the European Society of Hypertension (ESH) has established recommendations to ensure accurate measurements. The recommendations consider variations in measurement height and compare accuracy after blood pressure is elevated through aerobic exercise or low-intensity repetitive exercises, such as handgrip exercises. This study aims to follow the 2023 European Society of Hypertension recommendations by measuring blood pressure with the arm positioned vertically more than 20 centimeters below the standard position and comparing the results obtained after repeated handgrip exercises with those obtained using the standard method.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Blood Pressure Hypertension Blood Pressure, High Blood Pressure, Low Hypotension

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

DIAGNOSTIC

Blinding Strategy

NONE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Subjects requiring 24-hour ambulatory blood pressure monitoring

Subjects prescribed for ambulatory blood pressure monitor (ABPM) measure 24-hour blood pressure using both the CART BP and sphygmomanometer

Group Type EXPERIMENTAL

CART BP

Intervention Type DEVICE

A ring-type medical device worn by the subject that non-invasively measures systolic and diastolic blood pressure, as well as pulse rate.

sphygmomanometer

Intervention Type DEVICE

Blood pressure measurement method utilizing a two-headed stethoscope, allowing two observers to simultaneously hear the Korotkoff sounds.

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

CART BP

A ring-type medical device worn by the subject that non-invasively measures systolic and diastolic blood pressure, as well as pulse rate.

Intervention Type DEVICE

sphygmomanometer

Blood pressure measurement method utilizing a two-headed stethoscope, allowing two observers to simultaneously hear the Korotkoff sounds.

Intervention Type DEVICE

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

* 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

Exclusion Criteria

* 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)

Minimum Eligible Age

18 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes