Actively Recruiting

Age: 40Years - 80Years
All Genders
NCT07252830

Identification of Asymptomatic Patients at Very High Cardiovascular Risk: Contribution of a Strategy Based on Carotid and Coronary Explorations, Compared to Simple Risk Calculation Using the European "SCORE 2" Algorithm. (IDEA-CVR)

Led by Elsan · Updated on 2025-11-28

1000

Participants Needed

1

Research Sites

227 weeks

Total Duration

On this page

Sponsors

E

Elsan

Lead Sponsor

P

Polyclinique Poitiers

Collaborating Sponsor

AI-Summary

What this Trial Is About

To prevent myocardial infarction ( MI), coronary atheroma development by LDL-cholesterol deposition in the arterial wall is the basis. Since atheromatous plaques develop slowly before becoming symptomatic, their early detection in asymptomatic patients and the implementation of an effective strategy to prevent their progression constitute the most promising primary prevention strategy. In younger subjects, the main modifiable pro-atheromatous factors are smoking and an excessively high LDL-C level, partly genetically predetermined, but also favored by a diet too rich in saturated fats and a lack of physical activity. In the French national MI registry, the average age of patients is 62 years (Arch Cardiovasc Dis 2021 Oct;114(10):647-655). Half of MIs therefore occur at working age due to rupture of atheromatous plaques, which had developed during the months/years preceding the acute event. According to the latest recommendations of the European Society of Cardiology (ESC) on CV prevention published in August 2021, the visualization of coronary or carotid atheromatous plaques justifies considering the patient as having atherosclerotic cardiovascular disease (ASCVD), and automatically places them in the "very high CV risk" category, with an LDL-cholesterol target of \<0.55 g/L. However, these recommendations do not clearly define the criteria justifying the use of imaging in asymptomatic patients. In current practice, CV risk stratification for asymptomatic patients with no prior CV disease is currently based on risk calculation using the European "SCORE 2" algorithm, available online. It allows the calculation of the absolute risk in % of occurrence of a fatal or non-fatal CV event (myocardial infarction, stroke) over 10 years. The main objective of this study is to describe patients reclassified as "very high CV risk" following the detection of atheroma plaques formed in relation to their risk level estimated by SCORE2.

CONDITIONS

Official Title

Identification of Asymptomatic Patients at Very High Cardiovascular Risk: Contribution of a Strategy Based on Carotid and Coronary Explorations, Compared to Simple Risk Calculation Using the European "SCORE 2" Algorithm. (IDEA-CVR)

Who Can Participate

Age: 40Years - 80Years
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Age over 40 years and under 80 years referred to general cardiology consultation
  • LDL-cholesterol level greater than 1.6 g/L, or LDL-cholesterol level greater than 1.3 g/L with at least one major cardiovascular risk factor such as smoking, hypertension, or diabetes
  • Coronary artery reserve assessment and EDTSA performed in a day hospital
Not Eligible

You will not qualify if you...

  • Known or suspected carotid atherosclerotic disease
  • Known or suspected significant ischemic heart disease at the time of the initial consultation
  • Protected adult patient under guardianship, curatorship, or other legal protection, or deprived of liberty by judicial or administrative decision
  • Patient opposes use of their health data
  • Patient may have limited understanding of the information sheet

AI-Screening

AI-Powered Screening

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Trial Site Locations

Total: 1 location

1

Polyclinqiue de Poitiers

Poitiers, France, 86000

Actively Recruiting

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Research Team

A

Aurelia Cassany, Dr

CONTACT

How is the study designed?

Study Type

OBSERVATIONAL

Masking

N/A

Allocation

N/A

Model

N/A

Primary Purpose

N/A

Number of Arms

1

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