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Reliability and Validity of the Vicorder Device When Measuring Pulse Wave Velocity Within Chronic Stroke Patients

NCT04342143 · Status: RECRUITING · Type: OBSERVATIONAL · Enrollment: 20

Last updated 2024-05-17

No results posted yet for this study

Summary

Stroke is a major global health problem and main cause of disability worldwide. Blood pressure control is important for good health in stroke patients. Measuring central blood pressure (the blood pressure which is found in the heart) and measuring the stiffness of your arteries will give practitioners, clinicians and researcher's important information over and above what is usually obtained from peripheral blood pressure in the arm. The most validated and most recognisable equipment for central blood pressure and arterial stiffness is the SphygmoCor XCEL. However, the Doppler Ultrasound is used more often in population-based studies and has been shown to be a precise and accurate measurement. Although these devices are validated, they both require a highly skilled operator and are quite time-consuming. As such, it is important to explore less operator dependent and time consuming devices, such as the Vicorder, as this could be essential for researchers and clinicians.Therefore, this study will investigate whether the Vicorder device is valid and reliable when measuring these outcomes and if so could be implemented in large research studies and potenially be used by clinicians.

Conditions

Interventions

DEVICE

Blood pressure and ultrasound assessment

No intervention. Participants will undertake an overnight fast prior to each assessment (only water is allowed to be consumed prior to the assessment). Participants will be asked to visit the lab on four separate occasions; the first two sessions will involve triplicated measures of carotid-femoral PWV (cfPWV), brachial-femoral PWV (bfPWV), brachial-ankle PWV (baPWV), femoral-ankle PWV (faPWV) and TT by the Vicorder in both seated and supine position. The SphygmoCor will also be used to assess cfPWV in both seated and supine. During the third and fourth sessions individuals will be randomised into either a supine or seated position. A 3 lead ECG will be attached and ultrasound video clips will be taken at the carotid, brachial, femoral and posterior tibial artery on both the symptomatic and asymptomatic sides to look at stiffness and blood velocity. Following this, the Vicorder will be used to look at cfPWV, bfPWV, baPWV, faPWV and TT on both sides.

Sponsors & Collaborators

  • University of Winchester

    lead OTHER

Eligibility

Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2020-03-01
Primary Completion
2024-06-30
Completion
2024-06-30
FDA Device
Yes

Countries

  • United Kingdom

Study Locations

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Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04342143 on ClinicalTrials.gov