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

Status

Completed

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT04300738

Acronym

VOP-SCC

Enrollment

220

Registered

2020-03-09

Start date

2020-05-15

Completion date

2022-02-15

Last updated

2022-03-09

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Cardiovascular Risk Factor

Keywords

Pulse Wave Velocity, Coronary Calcium Score,, Cardiovascular event,, Cardiovascular risk factor

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

Interventions

DEVICECCS wit CT Scann measurement

Measurement with 2 devices

Study design

Allocation

Intervention model

SINGLE_GROUP

Primary purpose

PREVENTION

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame	Description
Coronary Calcium Score	12 months	Coronary Calcium Score,
Pulse Wave Velocity	12 months	—

Countries

France

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026