Cardiovascular Risk FactorNCT04303546
VOPITB a New Devices to Determine Peripheral Arterial Stiffness: Validation Study
An observational study of Cardiovascular Risk Factor and Cardiovascular Diseases, run by University of Extremadura.
Trial summary
Our group has developed a device called "Velocidad Onda de Pulso Indice Tobillo Brazo (VOPITB)" . In this device the oscillometric method is used for easily and accurately measure the pulse wave velocity PWV in the arms and legs separately, allowing new arterial stiffness indices to be studied (sum, difference, ratio… Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Cardiovascular Risk Factor, Cardiovascular Diseases, Atherosclerosis of Artery
- What is being tested?
- arterial stiffness measurements
- Type of treatment
- Medical device
- How many people
- 120 participants
- Where
- No sites listed yet
- Study dates
- 8 Mar 2020to 15 Dec 2020
- How long will I take part?
- 8 Months
- 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 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: The sample size has been calculated in order to provide that a difference between the CAVI values obtained from measurement of both devices, VOPITB and VaSera, shall be up to of 0.8 points in comparison with the CAVI reference values for Spanish adults population [21]. the base parameters used to calculate the sample size were as follows: standard deviation (sd) of CAVI measured by VaSera VS-1500 and VOPITB (1.44), mean difference between CAVI measurements (0.8), confidence level (95%), and power (80%). Thus, the estimated sample size was found as 102 patients. In addition, for compensating possible incomplete data sets from patients who could withdraw or fail to complete the study, 20% were added. Finally, a total of 120 subjects (a minimum of 40% of subjects for each gender group) will be evaluated according to the following criteria: * < 30 years (40 subjects) * 30 - 60 years (40 subjects) * > 60 years (40 subjects)
Who may be able to join
- Subjects ≥ 18 years who agree to participate in the study and do not meet any of the exclusion criteria.
Who cannot join
- History of CVD (ischaemic heart disease, stroke or peripheral arterial disease)
- Atrial fibrillation or other cardiac rhythm disorders
- Pacemaker-dependent
- Impalpable arterial pulse at site of measurement
- Pregnancy
- Terminal condition
- Age under 18 years
About this study
Official title: VOPITB a New Devices to Determine Peripheral Arterial Stiffness: Protocol for Validation Study
Our group has developed a device called "Velocidad Onda de Pulso Indice Tobillo Brazo (VOPITB)" . In this device the oscillometric method is used for easily and accurately measure the pulse wave velocity PWV in the arms and legs separately, allowing new arterial stiffness indices to be studied (sum, difference, ratio, baPWV and CAVI). The aim of our study will be to validate the PWV measures by VOPITB with other references devices that measures arterial stiffness. Moreover we will perform a clinical study to assess the clinical utility of VOPITB.
- Being tested
- arterial stiffness measurements
- Keywords
- arterial stiffnes, pulse wave velocity, VOPITB, validation
- Medical subject headings
- Cardiovascular Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
arterial stiffness measurementsDevice
We will measure arterial stiffness by VOPITB and with others devices to validate VOPITB
| Study group | Role | What they receive |
|---|---|---|
| < 30 years | Not described Receives: Device: arterial stiffness measurements | |
| 30-60 years | Not described Receives: Device: arterial stiffness measurements | |
| > 60 years | Not described Receives: Device: arterial stiffness measurements |
What is being measured
The primary outcome is the main question the study is designed to answer.
cardio-ankle vascular index (CAVI) validation
We will determine CAVI with VOPITB, as well as its validation against the reference device (VaSera VS-1500) and assess its clinical utility.
Measured: 8 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Mar 2020
- Study start8 Mar 2020 (estimated)
- Primary completion15 Apr 2020 (estimated)
- Study completion15 Dec 2020 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Cardiovascular Risk FactorStudies 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
- Other
- Time perspective
- Cross-sectional
- Enrolment
- 120 participants (estimated)
- Target duration
- 8 Months
Sponsor and investigators
- Lead sponsor
- University of Extremadura
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Sergio Rico Martín, University of Extremadura
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04303546
- Sponsor's protocol ID
- VOPITB STUDY
- Status last verified
- Mar 2020
- First submitted
- 8 Mar 2020
- Last updated
- 11 Mar 2020
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Rico Martin S, Vassilenko V, de Nicolas Jimenez JM, Rey Sanchez P, Serrano A, Martinez Alvarez M, Calderon Garcia JF, Sanchez Munoz-Torrero JF. Cardio-ankle vascular index (CAVI) measured by a new device: protocol for a validation study. BMJ Open. 2020 Oct 20;10(10):e038581. doi: 10.1136/bmjopen-2020-038581.
PubMed 33082193
Study at a glance
From the registry record, last updated by the sponsor on 11 Mar 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- VOPITB a New Devices to Determine Peripheral Arterial Stiffness: Protocol for Validation Study
- ClinicalTrials.gov ID
- NCT04303546
- Acronym / sponsor ID
- VOPITB STUDY
- Keywords
- arterial stiffnes, pulse wave velocity, VOPITB, validation
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 120 participants (estimated)
- Lead sponsor
- University of ExtremaduraUniversity, hospital or other
- Study start
- 8 Mar 2020 (estimated)
- Primary completion
- 15 Apr 2020 (estimated)
- Study completion
- 15 Dec 2020 (estimated)
- First posted
- 11 Mar 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.
Our group has developed a device called "Velocidad Onda de Pulso Indice Tobillo Brazo (VOPITB)" . In this device the oscillometric method is used for easily and accurately measure the pulse wave velocity PWV in the arms and legs separately, allowing new arterial stiffness indices to be studied (sum, difference, ratio, baPWV and CAVI). The aim of our study will be to validate the PWV measures by VOPITB with other references devices that measures arterial stiffness. Moreover we will perform a clinical study to assess the clinical utility of VOPITB.
Study design
- Observational model
- Other
- Time perspective
- Cross-sectional
- Target follow-up
- 8 Months
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| < 30 years | – | Device: arterial stiffness measurements |
| 30-60 years | – | Device: arterial stiffness measurements |
| > 60 years | – | Device: arterial stiffness measurements |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- The sample size has been calculated in order to provide that a difference between the CAVI values obtained from measurement of both devices, VOPITB and VaSera, shall be up to of 0.8 points in comparison with the CAVI reference values for Spanish adults population [21]. the base parameters used to calculate the sample size were as follows: standard deviation (sd) of CAVI measured by VaSera VS-1500 and VOPITB (1.44), mean difference between CAVI measurements (0.8), confidence level (95%), and power (80%). Thus, the estimated sample size was found as 102 patients. In addition, for compensating possible incomplete data sets from patients who could withdraw or fail to complete the study, 20% were added. Finally, a total of 120 subjects (a minimum of 40% of subjects for each gender group) will be evaluated according to the following criteria: * < 30 years (40 subjects) * 30 - 60 years (40 subjects) * > 60 years (40 subjects)
Key inclusion criteria (1 listed)
- Subjects ≥ 18 years who agree to participate in the study and do not meet any of the exclusion criteria.
Key exclusion criteria (7 listed)
- History of CVD (ischaemic heart disease, stroke or peripheral arterial disease)
- Atrial fibrillation or other cardiac rhythm disorders
- Pacemaker-dependent
- Impalpable arterial pulse at site of measurement
- Pregnancy
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 |
|---|---|---|
| arterial stiffness measurementsWe will measure arterial stiffness by VOPITB and with others devices to validate VOPITB | Device | 30-60 years, < 30 years, > 60 years |
Primary outcome
cardio-ankle vascular index (CAVI) validation
Time frame: 8 months
We will determine CAVI with VOPITB, as well as its validation against the reference device (VaSera VS-1500) and assess its clinical utility.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Mar 2020.
- Derived from this study: PubMed 33082193Rico Martin S, Vassilenko V, de Nicolas Jimenez JM, Rey Sanchez P, Serrano A, Martinez Alvarez M, Calderon Garcia JF, Sanchez Munoz-Torrero JF. Cardio-ankle vascular index (CAVI) measured by a new device: protocol for a validation study. BMJ Open. 2020 Oct 20;10(10):e038581. doi: 10.1136/bmjopen-2020-038581.
- 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.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
An observational study of Cardiovascular Risk Factor and Cardiovascular Diseases, run by University of Extremadura.
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 1 inclusion and 7 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 11 Mar 2020. Status can change between updates, so confirm with the study contact before making plans.
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?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
cardio-ankle vascular index (CAVI) validation (time frame: 8 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04303546, which also lists 1 linked publication.
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 11 Mar 2020.