Cardiovascular Risk FactorVOP-SCCNCT04300738
Evaluation and Comparison of Two Biomarkers (VOP and SCC) for the Prognosis of the Occurrence of Clinical Cardiovascular Events
A study testing CCS wit CT Scann measurement in people with Cardiovascular Risk Factor, run by Clinique Bizet at 1 site in France.
Trial summary
The aim of our study is to assess the Cardiovascular risk and the quality of the arteries by comparing the Coronary Calcium Score SCC measured with a CT scann and the Pulse Wave Velocity PWV measured with pOpmeter for the prognosis at 6 months of clinical events. Is there a superiority of PWV compared to SCC: Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Cardiovascular Risk Factor
- What is being tested?
- CCS wit CT Scann measurement
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 220 participants
- Where
- 1 siteFrance
- Study dates
- 15 May 2020to 15 Feb 2022
- Phase
- Interventional
- 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
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Subject aged over 18
- Any Patient referred to the Bizet Clinic for a CT scan of the coronary arteries
- Subject affiliated to a social security scheme or beneficiary of such a scheme
- Lack of participation in another clinical study
Who cannot join
- Minor patient
- Patient with obliterating arterial disease of the lower limbs
- Patient with Sore fingers and hands
- Patient with arrhythmia that does not allow measurement of VOP
- Patient with limb amputation
- Major subject protected by law, under curatorship or tutorship
Trial locations and contacts
1 site in 1 country.
About this study
The aim of our study is to assess the Cardiovascular risk and the quality of the arteries by comparing the Coronary Calcium Score SCC measured with a CT scann and the Pulse Wave Velocity PWV measured with pOpmeter for the prognosis at 6 months of clinical events.
Is there a superiority of PWV compared to SCC:
Read the detailed description
Two method of cardiovascular risk screening are compared in patient going for Coronary Calcium Score measurement in a outpatient clinic. Ct Scann is expensive, learning time is for at least 2 years, and the reliability is operator dependent.
The Pulse Wave Velocity is measured using a new device with half an hour learning curve, and you get a result within 2 minutes.
- A non-invasive medical device vs invasive
- A better benefit-risk ratio
- A lower diagnostic cost both for equipment and for qualification for use and learning time
- Conditions
- Cardiovascular Risk Factor
- Being tested
- CCS wit CT Scann measurement
- Keywords
- Pulse Wave Velocity, Coronary Calcium Score,, Cardiovascular event,, Cardiovascular risk factor
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CCS wit CT Scann measurementDevice
Also called PWV measurement with pOpmètre
Measurement with 2 devices
| Study group | Role | What they receive |
|---|---|---|
| Patients undergoing CT scann for CCS determination | Other | Not described Receives: Device: CCS wit CT Scann measurement |
What is being measured
The primary outcome is the main question the study is designed to answer.
Coronary Calcium Score
Coronary Calcium Score,
Measured: 12 months
Pulse Wave Velocity
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Mar 2020
- Study start15 May 2020
- Primary completion5 Feb 2021
- Study completion15 Feb 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 220 participants (actual)
Sponsor and investigators
- Lead sponsor
- Clinique Bizet
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04300738
- Sponsor's protocol ID
- 2019-A01523-54
- Acronym
- VOP-SCC
- Status last verified
- Jun 2021
- First submitted
- 4 Mar 2020
- Last updated
- 9 Mar 2022
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Mar 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation and Comparison of Two Biomarkers (VOP and SCC) for the Prognosis of the Occurrence of Clinical Cardiovascular Events
- ClinicalTrials.gov ID
- NCT04300738
- Acronym / sponsor ID
- VOP-SCC / 2019-A01523-54
- Conditions
- Cardiovascular Risk Factor
- Keywords
- Pulse Wave Velocity, Coronary Calcium Score,, Cardiovascular event,, Cardiovascular risk factor
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 220 participants (actual)
- Lead sponsor
- Clinique BizetUniversity, hospital or other
- Study start
- 15 May 2020 (actual)
- Primary completion
- 5 Feb 2021 (actual)
- Study completion
- 15 Feb 2022 (actual)
- First posted
- 9 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.
The aim of our study is to assess the Cardiovascular risk and the quality of the arteries by comparing the Coronary Calcium Score SCC measured with a CT scann and the Pulse Wave Velocity PWV measured with pOpmeter for the prognosis at 6 months of clinical events.
Is there a superiority of PWV compared to SCC:
Detailed description
Two method of cardiovascular risk screening are compared in patient going for Coronary Calcium Score measurement in a outpatient clinic. Ct Scann is expensive, learning time is for at least 2 years, and the reliability is operator dependent.
The Pulse Wave Velocity is measured using a new device with half an hour learning curve, and you get a result within 2 minutes.
- A non-invasive medical device vs invasive
- A better benefit-risk ratio
- A lower diagnostic cost both for equipment and for qualification for use and learning time
Study design
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Patients undergoing CT scann for CCS determination | Other | Device: CCS wit CT Scann measurement |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Subject aged over 18
- Any Patient referred to the Bizet Clinic for a CT scan of the coronary arteries
- Subject affiliated to a social security scheme or beneficiary of such a scheme
- Lack of participation in another clinical study
Key exclusion criteria (6 listed)
- Minor patient
- Patient with obliterating arterial disease of the lower limbs
- Patient with Sore fingers and hands
- Patient with arrhythmia that does not allow measurement of VOP
- Patient with limb amputation
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 |
|---|---|---|
| CCS wit CT Scann measurementAlso: PWV measurement with pOpmètreMeasurement with 2 devices | Device | Patients undergoing CT scann for CCS determination |
Primary outcome
Coronary Calcium Score
Time frame: 12 months
Coronary Calcium Score,
Pulse Wave Velocity
Time frame: 12 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Mar 2022.
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing CCS wit CT Scann measurement in people with Cardiovascular Risk Factor, run by Clinique Bizet at 1 site in France.
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 4 inclusion and 6 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: finished, as of the sponsor's last update on 9 Mar 2022. 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 France. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Coronary Calcium Score (time frame: 12 months). 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 9 Mar 2022.