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

NCT04342143 | Recruiting DMC FDA Device

• 1 other identifier: Paine_Validity_VIC
• Study Type: observational
• Target: 20
• Locations: 1 country
• Sites: 1

Brief 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

Stroke

Outcome Measures

Primary Outcomes (2)

• Pulse Wave Velocity

  Pulse wave velocity will be assessed on four seperate days in both seated and supine posture. This will be measured with the Vicorder, Ultrasound \& SphygmoCor

  1 month

• Transit Time

  Transit time will be assessed on four seperate days in both seated and supine posture. This will be measured with the Vicorder, Ultrasound \& SphygmoCor

  1 month

Secondary Outcomes (2)

• Peripheral blood pressure

  1 month

• Pulse wave analysis

  1 month

Study Arms (1)

Stroke

Patients who have a diagnosis of stroke by a stroke consultant from UK National Health Service Trust within 3 months to 5 years of study start date.

Device: Blood pressure and ultrasound assessment

Interventions

Blood pressure and ultrasound assessment DEVICE

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.

Stroke

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Patients diagnosed with stroke by a stroke consultant at a local hospital will be eligible to participate.

You may qualify if:

• Diagnosis of stroke by a stroke cnsultant from a UK National Health Service Foundation Trust
• months to 5 years of study start date

Sponsors & Collaborators

• University of Winchester: lead

Study Sites (1)

Physiology Laboratory

Winchester, United Kingdom

RECRUITING

MeSH Terms

Conditions

Stroke

Interventions

Blood Pressure

Condition Hierarchy (Ancestors)

Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases

Intervention Hierarchy (Ancestors)

Vital Signs; Physical Examination; Diagnostic Techniques and Procedures; Diagnosis; Hemodynamics; Cardiovascular Physiological Phenomena; Circulatory and Respiratory Physiological Phenomena

Central Study Contacts

Eloise Paine, MSc

CONTACT

01962 675230; eloise.paine@winchester.ac.uk

James Faulkner, PhD

CONTACT

01962 624932; james.faulkner@winchester.ac.uk

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 8, 2020
• First Posted: April 10, 2020
• Study Start: March 1, 2020
• Primary Completion: June 1, 2024
• Study Completion: June 1, 2024
• Last Updated: May 17, 2024

Record last verified: 2024-05

Data Sharing

• IPD Sharing: Will not share

Locations

GB (1)