StrokeNCT04342143
Reliability and Validity of the Vicorder Device When Measuring Pulse Wave Velocity Within Chronic Stroke Patients
An observational study of Stroke, run by University of Winchester at 1 site in United Kingdom.
Trial 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… Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Stroke
- What is being tested?
- Blood pressure and ultrasound assessment
- Type of treatment
- Medical device
- How many people
- 20 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 1 Mar 2020to Jun 2024
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: Patients diagnosed with stroke by a stroke consultant at a local hospital will be eligible to participate.
Who may be able to join
- Diagnosis of stroke by a stroke cnsultant from a UK National Health Service Foundation Trust
- 3 months to 5 years of study start date
Who cannot join
None listed.
Trial locations and contacts
1 site in 1 country.
United Kingdom1 site, 1 recruiting
- Recruiting
Physiology Laboratory
Winchester
James Faulkner, PhD, 01962 624932 ext. 4932, james.faulkner@winchester.ac.uk
Helen Ryan-Stewart, MSc, 01962 624932 ext. 4932, helen.ryan@winchester.ac.uk
About this study
Official title: Reliability and Validity of the Vicorder Device When Measuring Pulse Wave Velocity and Transit Time Within Chronic Stroke Patients
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.
Read the detailed description
Twenty stroke patients will be recruited for this study. Participants will take part in four seperate assessments (2 hours each) with a minimum of 24 hour recovery between each session. Before each assessment participants will undertake an overnight fast (only water is allowed to be consumed prior to the assessment). If required, participants will take their medication the morning of each assessment and this will be noted.During the first session participants will be randomised into either a supine or seated condition. Participants will rest in this posture for 15 minutes. Triplicate measures of peripheral blood pressure and pulse wave analysis will be measured using the SphygmoCor XCEL and Vicorder device. A 3-lead ECG will be placed on the participant and ultrasound measures will be taken at the carotid, brachial, femoral and posterior tibial artery. This will examine the caroid-femoral pulse wave velocity (cfPWV), brachial-femoral pulse wave velocity (bfPWV), brachial-ankle pulse wave velocity (baPWV) and femoral-ankle pulse wave velocity (faPWV). Following this, the Vicorder device will be used to measure these segments. All measures will be on both symptomatic and asymptomatic sides. This procedure will be repeated in a seperate session whereby individuals will be in the other posture.
Session 3 and 4 will include participants resting for 15 minutes in a supine position. Triplicate measures of peripheral blood pressure and pulse wave analysis will be taken with the Vicorder. Followed by triplicate measures of cfPWV, bfPWV, baPWV and faPWV. This will be repeated in a seated position within the same session.
- Conditions
- Stroke
- Being tested
- Blood pressure and ultrasound assessment
- Medical subject headings
- Stroke
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Blood pressure and ultrasound assessmentDevice
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Device: Blood pressure and ultrasound assessment |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 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
Measured: 1 month
Secondary outcomes (2)
Peripheral blood pressure
Peripheral blood pressure will be measured on four seperate days in both supine and seated posture. This will be meausred with the SphygmoCor and Vicorder.
Measured: 1 month
Pulse wave analysis
Pulse wave analysis will be measured on four seperate days in both supine and seated posture. This will be meausred with the SphygmoCor and Vicorder.
Measured: 1 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Apr 2020
- Study start1 Mar 2020
- Primary completionJun 2024 (estimated)
- Study completionJun 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for StrokeStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Winchester
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04342143
- Sponsor's protocol ID
- Paine_Validity_VIC
- Status last verified
- May 2024
- First submitted
- 8 Apr 2020
- Last updated
- 17 May 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 May 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Reliability and Validity of the Vicorder Device When Measuring Pulse Wave Velocity and Transit Time Within Chronic Stroke Patients
- ClinicalTrials.gov ID
- NCT04342143
- Acronym / sponsor ID
- Paine_Validity_VIC
- Conditions
- Stroke
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- University of WinchesterUniversity, hospital or other
- Study start
- 1 Mar 2020 (actual)
- Primary completion
- Jun 2024 (estimated)
- Study completion
- Jun 2024 (estimated)
- First posted
- 10 Apr 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
Twenty stroke patients will be recruited for this study. Participants will take part in four seperate assessments (2 hours each) with a minimum of 24 hour recovery between each session. Before each assessment participants will undertake an overnight fast (only water is allowed to be consumed prior to the assessment). If required, participants will take their medication the morning of each assessment and this will be noted.During the first session participants will be randomised into either a supine or seated condition. Participants will rest in this posture for 15 minutes. Triplicate measures of peripheral blood pressure and pulse wave analysis will be measured using the SphygmoCor XCEL and Vicorder device. A 3-lead ECG will be placed on the participant and ultrasound measures will be taken at the carotid, brachial, femoral and posterior tibial artery. This will examine the caroid-femoral pulse wave velocity (cfPWV), brachial-femoral pulse wave velocity (bfPWV), brachial-ankle pulse wave velocity (baPWV) and femoral-ankle pulse wave velocity (faPWV). Following this, the Vicorder device will be used to measure these segments. All measures will be on both symptomatic and asymptomatic sides. This procedure will be repeated in a seperate session whereby individuals will be in the other posture.
Session 3 and 4 will include participants resting for 15 minutes in a supine position. Triplicate measures of peripheral blood pressure and pulse wave analysis will be taken with the Vicorder. Followed by triplicate measures of cfPWV, bfPWV, baPWV and faPWV. This will be repeated in a seated position within the same session.
Study design
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Stroke | – | Device: Blood pressure and ultrasound assessmentPatients 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. |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Patients diagnosed with stroke by a stroke consultant at a local hospital will be eligible to participate.
Key inclusion criteria (2 listed)
- Diagnosis of stroke by a stroke cnsultant from a UK National Health Service Foundation Trust
- 3 months to 5 years of study start date
Key exclusion criteria (0 listed)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Blood pressure and ultrasound assessmentNo 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. | Device | Stroke |
Primary outcome
Pulse Wave Velocity
Time frame: 1 month
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
Transit Time
Time frame: 1 month
Transit time will be assessed on four seperate days in both seated and supine posture. This will be measured with the Vicorder, Ultrasound \& SphygmoCor
2 secondary outcomes
Peripheral blood pressure
Time frame: 1 month
Pulse wave analysis
Time frame: 1 month
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 May 2024.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Stroke, run by University of Winchester at 1 site in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 0 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 17 May 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Eloise Paine, MSc (01962 675230, eloise.paine@winchester.ac.uk), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Pulse Wave Velocity (time frame: 1 month). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 May 2024; AzTrials last refreshed its copy on 31 Oct 2026.