Carotid-Femoral, Oscillometric and Estimated Pulse Wave Velocity
Trial statusNot yet recruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorHospital de Base
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
suspected hypertension diagnosis or
uncontrolled hypertension under treatment
Disqualifiers
less than 70% of the expected measurements or
fewer than 20 valid awake or seven valid sleeping measurements or
fewer than two valid daytime and one valid night-time measurement per hour
Trial population
Individuals older than 18 with a suspected hypertension diagnosis or under treatment who were referred to record twenty-four hours of ABPM either to confirm a hypertension diagnosis or evaluate uncontrolled hypertension. The participants will be selected in a specialized center in inner Brazil to diagnose and treat non-communicable diseases.
Trial design
Design model
Cohort
Time perspective
Cross-sectional
Treatments tested in this trial
Not listed
Trial groups
350 Participants
are grouped into 1 trial groupGroup A: Adults older than eighteen with elevated office BP, treated and untreated.
Trial outcomes
Primary outcomes
1
Concordance correlation coefficient
The concordance correlation coefficient evaluates the degree to which pairs of observations fall on the 45° line through the origin. The concordance correlation coefficient (ρc) contains a measurement of precision (ρ) and accuracy (Cb). * ρ is the Pearson correlation coefficient, which measures how far each observation deviates from the best-fit line, and is a measure of precision, and * Cb is a bias correction factor that measures how far the best-fit line deviates from the 45° line through the origin, and is a measure of accuracy.
Time frame
Through study completion, an average of 1 year.Secondary outcomes
1
Means
Means of cf-PWV, br-PWV, and e-PWV. Arithmetic mean: the arithmetic mean x ¯ x¯ is the sum of all observations divided by the number of observations n.
Time frame
Through study completion, an average of 1 year.Sponsors and contacts
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Source ClinicalTrials.gov
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