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

Not Applicable

Completed

• Conditions: Cardiovascular Risk Factor
• Interventions: Device: CCS wit CT Scann measurement

• Registration Number: NCT04300738
• Lead Sponsor: Clinique Bizet

Brief 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:

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.

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

Study Timeline

• Study First Submitted: 2020-03-04
• Study First Submitted QC: 2020-03-06
• Study First Posted: 2020-03-09
• Study Start: 2020-05-15
• Primary Completion: 2021-02-05
• Status Verified: 2021-06
• Study Completion: 2022-02-15
• Last Update Submitted: 2022-03-08
• Last Update Posted: 2022-03-09

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 220

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Patients undergoing CT scann for CCS determination	CCS wit CT Scann measurement	-

Primary Outcome Measures

Name	Time	Method
Coronary Calcium Score	12 months	Coronary Calcium Score,
Pulse Wave Velocity	12 months

Trial Locations

Locations (1)

Benkessou; 🇫🇷 Paris, France