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)

NCT ID: NCT07252830

Last Updated: 2025-11-28

Basic Information

• Recruitment Status: RECRUITING
• Total Enrollment: 1000 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2021-09-12
• Study Completion Date: 2026-01-20

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.

Detailed Description

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

Conditions

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

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: OTHER

Study Groups

Asymptomatic patients, in screening / primary prevention

SCORE2

Intervention Type: 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.

Interventions

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.

Intervention Type: OTHER

Eligibility Criteria

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

• Minimum Eligible Age: 40 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Polyclinique Poitiers

UNKNOWN

Sponsor Role: collaborator

Elsan

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Polyclinqiue de Poitiers

Poitiers, , France

Site Status: RECRUITING

Countries

France

Central Contacts

Aurelia Cassany, Dr

Role: CONTACT

cassany@elsan.care

Facility Contacts

Barnabas Gellen, Dr

Role: primary

+33 5 49 61 71 99

Other Identifiers

IDEA-CVR

Identifier Type: -

Identifier Source: org_study_id