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

Launched by SKY LABS · Jul 16, 2024

Keywords

ClinConnect Summary

This clinical trial is studying a new type of blood pressure monitor called CART BP, which is a wearable ring that can measure blood pressure without the traditional cuff. The goal is to see how accurately this device works compared to the usual method of measuring blood pressure with a stethoscope. The study will look at how well the CART BP device performs while participants are sitting, standing, and exercising, focusing on people who might have high or low blood pressure.

To join the trial, participants need to be between the ages of 18 and 80 and agree to participate by signing a consent form. However, people with certain health conditions, such as serious heart issues or high blood pressure readings, won’t be eligible. Those who take part can expect to have their blood pressure measured in different positions and during exercise to help researchers understand how accurate the new device is. This study is not yet recruiting participants, but it aims to provide valuable information about a potentially easier way to monitor blood pressure.

Gender

ALL

Eligibility criteria

• 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)