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

NCT ID: NCT04300738

Last Updated: 2022-03-09

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

220 participants

Study Classification

INTERVENTIONAL

Study Start Date

2020-05-15

Study Completion Date

2022-02-15

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Cardiovascular Risk Factor

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

PREVENTION

Blinding Strategy

NONE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Patients undergoing CT scann for CCS determination

Group Type OTHER

CCS wit CT Scann measurement

Intervention Type DEVICE

Measurement with 2 devices

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

CCS wit CT Scann measurement

Measurement with 2 devices

Intervention Type DEVICE

Other Intervention Names

Discover alternative or legacy names that may be used to describe the listed interventions across different sources.

PWV measurement with pOpmètre

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Clinique Bizet

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Responsibility Role SPONSOR

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Benkessou

Paris, , France

Site Status

Countries

Review the countries where the study has at least one active or historical site.

France

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

2019-A01523-54

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.

Vital Signs Camera Study
NCT06140433 COMPLETED NA
NIBP Validation Study
NCT05673408 RECRUITING