Carotid-Femoral, Oscillometric and Estimated Pulse Wave Velocity

Sponsor
Hospital de Base
Study ID
NCT06836622
Status
Not Yet Recruiting

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Conditions

  • Arterial Stiffness
  • Hypertension
  • Pulse Wave Analysis
  • Pulse Wave Velocity

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Study Details

What is the purpose of this research? This research aims to compare three different methods of measuring pulse wave velocity, which is the main parameter used for assessing arterial stiffness. This parameter is as important as blood pressure in predicting future cardiovascular risk. The investigators intend to compare carotid-femoral pulse wave velocity, which is the gold standard for measuring arterial stiffness, with brachial pulse wave velocity measured using a device similar to a blood pressure monitor and a mathematical formula validated in a large European population. Who is eligible for this survey? Anyone aged 18 or older who has been invited may participate, provided they sign an informed consent form. Where will the field research be conducted? The research will be conducted at a health center specializing in the treatment of hypertension. This center is a reference for outpatient blood pressure monitoring in the city of Uberaba (MG), Brazil. Patients enrolled in the study will also be included in the Hypertension Center of the Faculdade de Medicina de São José do Rio Preto (FAMERP). Which procedures will be performed by research participants? All participants who consent will answer some questions about their demographic and health information. A trained nurse will measure their weight, height, and blood pressure after a 5-minute rest, and then measure carotid-femoral pulse wave velocity. The participant will lie down on a bed and the nurse will place a sensor on the middle of their neck and the groin. The device will automatically deliver the parameters. At least three measurements are required for each participant. Measurements normally take between 10 and 15 minutes. Then, participants will wear a device to record blood pressure and pulse wave velocity for 24 hours. The nurse will fit the cuff around the participant's arm and attach the monitoring device to a belt around their waist. The device will take measurements every 20 to 30 minutes. 24 hours later, the participant must return to the research venue to have the equipment removed. What are the risks and adverse events of the procedures? There are no known risks or adverse events (AEs) associated with carotid-femoral pulse wave velocity measurements. The risks of this research are minimal, limited to discomfort during the AMBP recording, which occurs at a low frequency. However, excessive arm pain, allergic reactions, and edema may occur. To minimize these risks, a nurse will be available via telephone to aid all participants during the AMBP recordings.

Key Dates

First listed
Feb 20, 2025
Start date
Jul 1, 2026
Status verified
May 2026
Primary completion
Jul 6, 2027
Completion
Dec 1, 2027

Study Design

Enrollment
350 participants (estimated)

Arms

  • Arm: Adults older than eighteen with elevated office BP, treated and untreated.
    All participants were referred by a physician to perform ambulatory blood pressure monitoring (ABPM) to confirm a hypertension diagnosis or evaluate uncontrolled hypertension.

Primary Outcome Measure

Concordance correlation coefficient [ Time Frame: Through study completion, an average of 1 year. ]

Central Contacts

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