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

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:

Study Overview

• Status: Completed
• Conditions: Cardiovascular Risk Factor
• Intervention / Treatment: Device: CCS wit CT Scann measurement

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 Type: Interventional
• Enrollment (Actual): 220
• Phase: Not Applicable

Contacts and Locations

Study Locations

• France
  • Paris, France, 75016
    • Benkessou

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Other: Patients undergoing CT scann for CCS determination	Device: CCS wit CT Scann measurement; Measurement with 2 devices; Other Names: PWV measurement with pOpmètre

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Pulse Wave Velocity		12 months
Coronary Calcium Score	Coronary Calcium Score,	12 months

Collaborators and Investigators

• Sponsor: Clinique Bizet

Study record dates

Study Major Dates

• Study Start (Actual): May 15, 2020
• Primary Completion (Actual): February 5, 2021
• Study Completion (Actual): February 15, 2022

Study Registration Dates

• First Submitted: March 4, 2020
• First Submitted That Met QC Criteria: March 6, 2020
• First Posted (Actual): March 9, 2020

Study Record Updates

• Last Update Posted (Actual): March 9, 2022
• Last Update Submitted That Met QC Criteria: March 8, 2022
• Last Verified: June 1, 2021

More Information

Terms related to this study

• Keywords: Pulse Wave Velocity; Cardiovascular risk factor; Coronary Calcium Score,; Cardiovascular event,
• Other Study ID Numbers: 2019-A01523-54

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No