Evaluation and Comparison of Two Biomarkers (VOP and SCC) for the Prognosis of the Occurrence of Clinical Cardiovascular Events (VOP-SCC)

Clinique Bizet

Status: Completed

Conditions: Cardiovascular Risk Factor

Treatments: Device: CCS wit CT Scann measurement

Study type: Interventional

Funder types: Other

Identifiers

NCT04300738

2019-A01523-54

Details and patient eligibility

About

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:

Full 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.

1. A non-invasive medical device vs invasive
2. A better benefit-risk ratio
3. A lower diagnostic cost both for equipment and for qualification for use and learning time

Enrollment: 220 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

1. Subject aged over 18
2. Any Patient referred to the Bizet Clinic for a CT scan of the coronary arteries
3. Subject affiliated to a social security scheme or beneficiary of such a scheme
4. Lack of participation in another clinical study

Exclusion criteria

1. Minor patient
2. Patient with obliterating arterial disease of the lower limbs
3. Patient with Sore fingers and hands
4. Patient with arrhythmia that does not allow measurement of VOP
5. Patient with limb amputation
6. Major subject protected by law, under curatorship or tutorship

Trial design

Primary purpose: Prevention

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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220 participants in 1 patient group

Patients undergoing CT scann for CCS determination

Other group

Treatment:

Device: CCS wit CT Scann measurement