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)

NCT07252830 | Recruiting

• 1 other identifier: IDEA-CVR
• Study Type: observational
• Target: 1,000
• Locations: 1 country
• Sites: 1

Brief Summary

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

Myocardial Infarction; Atheroma; Cholesterol; Cardiovascular (CV) Risk

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (1)

Asymptomatic patients, in screening / primary prevention

Other: SCORE2

Interventions

SCORE2 OTHER

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.

Asymptomatic patients, in screening / primary prevention

Eligibility Criteria

• Age: 40 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Cardiology team of the Poitiers polyclinic (France)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Elsan: lead
• Polyclinique Poitiers: collaborator

Study Sites (1)

Polyclinqiue de Poitiers

Poitiers, 86000, France

RECRUITING

MeSH Terms

Conditions

Myocardial Infarction; Plaque, Atherosclerotic

Condition Hierarchy (Ancestors)

Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Vascular Diseases; Infarction; Ischemia; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Necrosis; Pathological Conditions, Anatomical

Central Study Contacts

Aurelia Cassany, Dr

CONTACT

cassany@elsan.care

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: OTHER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 19, 2025
• First Posted: November 28, 2025
• Study Start: September 12, 2021
• Primary Completion: December 20, 2025
• Study Completion: January 20, 2026
• Last Updated: November 28, 2025

Record last verified: 2025-09

Locations

FR (1)