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)

Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age40-80
SponsorElsan

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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

Disqualifiers

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.

Trial population

Cardiology team of the Poitiers polyclinic (France)

Trial design

Design model

Cohort

Time perspective

Other

Treatments tested in this trial

  • SCORE2

    Other intervention

    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.

Treatment groups

1,000 Participants
are divided into 1 treatment group
Group A: Asymptomatic patients, in screening / primary prevention1 intervention

Trial outcomes

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).

Time frame
12 months

Secondary outcomes

Other outcomes

Sponsors and contacts

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Elsan

Lead sponsor

Polyclinique Poitiers

Collaborator