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) (IDEA-CVR)

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.

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.

Study Overview

• Status: Recruiting
• Conditions: Myocardial Infarction; Cholesterol; Atheroma; Cardiovascular (CV) Risk
• Intervention / Treatment: Other: SCORE2

Detailed Description

It is a national, single-center, retrospective and prospective study on the collection of routine care data.

• Study Type: Observational
• Enrollment (Estimated): 1000

Contacts and Locations

• Study Contact: Name: Aurelia Cassany, Dr; Email: cassany@elsan.care

Study Locations

• France
  • Poitiers, France, 86000
    • Recruiting
    • Polyclinqiue de Poitiers
    • Contact: Barnabas Gellen, Dr; Phone Number: +33 5 49 61 71 99

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

Cardiology team of the Poitiers polyclinic (France)

Description

Inclusion Criteria:

• Age > 40 years and < 80 years referred to general cardiology consultation
• LDL-C level > 1.6 g/L, or LDL-C level > 1.3 g/L with at least one associated major cardiovascular (CV) risk factor (RCF) (smoking, hypertension, diabetes).
• Coronary artery reserve assessment and EDTSA performed in a day hospital

Exclusion Criteria:

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

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Asymptomatic patients, in screening / primary prevention	Other: SCORE2; the European algorithm "SCORE 2", available online (figure 1). 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Very high risk cardiovascular (yes/no)	Patients reclassified as "very high CV risk" (Yes/No) compared to the risk level estimated by SCORE2. SCORE2 is determined by an online calculator from the European Society of Cardiology (ESC).	12 months

Collaborators and Investigators

• Sponsor: Elsan
• Collaborators: Polyclinique Poitiers

Study record dates

Study Major Dates

• Study Start (Actual): September 12, 2021
• Primary Completion (Estimated): December 20, 2025
• Study Completion (Estimated): January 20, 2026

Study Registration Dates

• First Submitted: November 19, 2025
• First Submitted That Met QC Criteria: November 19, 2025
• First Posted (Actual): November 28, 2025

Study Record Updates

• Last Update Posted (Actual): November 28, 2025
• Last Update Submitted That Met QC Criteria: November 19, 2025
• Last Verified: September 1, 2025

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Vascular Diseases; Cardiovascular Diseases; Pathologic Processes; Pathological Conditions, Anatomical; Heart Diseases; Infarction; Necrosis; Myocardial Ischemia; Ischemia; Pathological Conditions, Signs and Symptoms; Plaque, Atherosclerotic; Myocardial Infarction
• Other Study ID Numbers: IDEA-CVR

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No