NCT04300738

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:

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
220

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started May 2020

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

March 4, 2020

Completed
5 days until next milestone

First Posted

Study publicly available on registry

March 9, 2020

Completed
2 months until next milestone

Study Start

First participant enrolled

May 15, 2020

Completed
9 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 5, 2021

Completed
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

February 15, 2022

Completed
Last Updated

March 9, 2022

Status Verified

June 1, 2021

Enrollment Period

9 months

First QC Date

March 4, 2020

Last Update Submit

March 8, 2022

Conditions

Cardiovascular Risk Factor

Keywords

Pulse Wave VelocityCoronary Calcium Score,Cardiovascular event,Cardiovascular risk factor

Outcome Measures

Primary Outcomes (2)

  • Coronary Calcium Score

    Coronary Calcium Score,

    12 months

  • Pulse Wave Velocity

    12 months

Study Arms (1)

Patients undergoing CT scann for CCS determination

OTHER
Device: CCS wit CT Scann measurement

Interventions

CCS wit CT Scann measurementDEVICE

Measurement with 2 devices

Also known as: PWV measurement with pOpmètre
Patients undergoing CT scann for CCS determination

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Benkessou

Paris, 75016, France

Location

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
PREVENTION
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 4, 2020

First Posted

March 9, 2020

Study Start

May 15, 2020

Primary Completion

February 5, 2021

Study Completion

February 15, 2022

Last Updated

March 9, 2022

Record last verified: 2021-06

Locations

FR(1)