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

Cardiovascular Risk Factor Clinical Trial

— VOP-SCC  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04300738
• Other study ID #: 2019-A01523-54
• Status: Completed
• Phase: N/A
• Start date: May 15, 2020
• Est. completion date: February 15, 2022

Study information

• Verified date: June 2021
• Source: Clinique Bizet
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical 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:

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 220
• Est. completion date: February 15, 2022
• Est. primary completion date: February 5, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Cardiovascular Risk Factor

Intervention

Device:
• CCS wit CT Scann measurement
Measurement with 2 devices

Locations

Country	Name	City	State
France	Benkessou	Paris

Sponsors (1)

Lead Sponsor	Collaborator
Clinique Bizet

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Coronary Calcium Score	Coronary Calcium Score,	12 months
Primary	Pulse Wave Velocity		12 months