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OpenTrials
Completed

NCT Number: NCT04300738

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

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:

Completed

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Benkessou

Paris, 75016, France

About this study

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.

  • A non-invasive medical device vs invasive
  • A better benefit-risk ratio
  • A lower diagnostic cost both for equipment and for qualification for use and learning time

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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

Exclusion criteria

  • 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

Treatment and study plan

CCS wit CT Scann measurement

Device

Measurement with 2 devices

Other names: PWV measurement with pOpmètre

Primary outcomes

  1. Coronary Calcium Score

    Time frame: 12 months

    Coronary Calcium Score,

  2. Pulse Wave Velocity

    Time frame: 12 months

Sponsors and collaborators

Lead sponsor

Clinique Bizet

Other

Registry information

Acronym: VOP-SCC

Important dates

Study start
2020
Primary completion
2021
Study completion
2022
First posted
Mar 9, 2020
Registry last updated
Mar 9, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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