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)
| NCT ID | NCT07252830 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Elsan |
| Condition | Myocardial Infarction |
| Study Type | OBSERVATIONAL |
| Enrollment | 1,000 participants |
| Start Date | 2021-09-12 |
| Primary Completion | 2025-12-20 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
This is an observational study. You will not receive an experimental treatment; researchers will collect data based on your existing condition or standard treatment.
This trial targets 1,000 participants in total. It began in 2021-09-12 with a primary completion date of 2025-12-20.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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.
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
Contact & Investigator
Aurelia Cassany, Dr
✉ cassany@elsan.careFrequently Asked Questions
Who can join the NCT07252830 clinical trial?
This trial is open to participants of all sexes, aged 40 Years or older, up to 80 Years, studying Myocardial Infarction. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT07252830 currently recruiting?
Yes, NCT07252830 is actively recruiting participants. Contact the research team at cassany@elsan.care for enrollment information.
Where is the NCT07252830 trial being conducted?
This trial is being conducted at Poitiers, France.
Who is sponsoring the NCT07252830 clinical trial?
NCT07252830 is sponsored by Elsan. The trial plans to enroll 1,000 participants.