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

Sponsor
Clinique Bizet (Other)
Overall Status
Completed
CT.gov ID
NCT04300738
Collaborator
(none)
220
1
1
21.1
10.4

Study Details

Study Description

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:
Condition or Disease Intervention/Treatment Phase
  • Device: CCS wit CT Scann measurement
N/A

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 Design

Study Type:
Interventional
Actual Enrollment :
220 participants
Allocation:
N/A
Intervention Model:
Single Group Assignment
Masking:
None (Open Label)
Primary Purpose:
Prevention
Official Title:
Evaluation and Comparison of Two Biomarkers (VOP and SCC) for the Prognosis of the Occurrence of Clinical Cardiovascular Events
Actual Study Start Date :
May 15, 2020
Actual Primary Completion Date :
Feb 5, 2021
Actual Study Completion Date :
Feb 15, 2022

Arms and Interventions

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
  • Outcome Measures

    Primary Outcome Measures

    1. Coronary Calcium Score [12 months]

      Coronary Calcium Score,

    2. Pulse Wave Velocity [12 months]

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    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

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Benkessou Paris France 75016

    Sponsors and Collaborators

    • Clinique Bizet

    Investigators

    None specified.

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Clinique Bizet
    ClinicalTrials.gov Identifier:
    NCT04300738
    Other Study ID Numbers:
    • 2019-A01523-54
    First Posted:
    Mar 9, 2020
    Last Update Posted:
    Mar 9, 2022
    Last Verified:
    Jun 1, 2021
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Keywords provided by Clinique Bizet

    Study Results

    No Results Posted as of Mar 9, 2022