Actively Recruiting
Identification of Asymptomatic Patients at Very High Cardiovascular Risk Using Carotid and Coronary Imaging Compared to the European SCORE 2 Risk Calculator
Led by Elsan · Updated on 2025-11-28
1000
Participants Needed
1
Research Sites
4 weeks
Total Duration
On this page
Sponsors
E
Elsan
Lead Sponsor
P
Polyclinique Poitiers
Collaborating Sponsor
AI-Summary
What this Trial Is About
Researchers are investigating how to better identify people without symptoms who may be at very high risk for heart attacks due to the buildup of fatty plaques in arteries, known as atheroma. The study focuses on adults aged 40 to 80 and evaluates a strategy that uses imaging of carotid and coronary arteries compared to using the European SCORE2 risk calculator alone. This approach aims to improve early detection and prevention of cardiovascular events by finding plaques before symptoms appear. The study collects data from routine care in a national, single-center design without intervening treatments. Participants have their coronary artery reserve and endothelial function tested during a day hospital visit. The main tool compared is the SCORE2 algorithm, which estimates the 10-year risk of fatal or non-fatal heart attacks and strokes based on clinical factors. Imaging results are used to reclassify patients' cardiovascular risk levels. Participants will be monitored to see if they are classified as very high cardiovascular risk within 12 months based on plaque detection and risk scores. The study involves reviewing clinical data and test results from cardiology consultations. The goal is to better understand how adding artery imaging can improve risk prediction beyond traditional methods and support more targeted prevention strategies for heart disease.
CONDITIONS
Brief Title
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)
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age over 40 years and under 80 years referred to general cardiology consultation
- LDL cholesterol level above 1.6 g/L, or above 1.3 g/L with at least one major cardiovascular risk factor such as smoking, hypertension, or diabetes
- Coronary artery reserve assessment and endothelial function testing performed during a day hospital visit
You will not qualify if you...
- Known or suspected carotid atherosclerotic disease
- Known or suspected significant ischemic heart disease at the time of initial consultation
- Protected adult patients under legal guardianship or deprived of liberty by judicial or administrative decision
- Patient opposition to the use of their health data
- Limited understanding of the study information sheet by the patient
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - 1 day
Participants undergo carotid and coronary explorations including coronary artery reserve assessment and endothelial function testing during a day hospital visit as part of routine care.
1 day hospital visit (in-person)
Duration - 12 months
Participants are observed based on routine care data to identify cardiovascular risk over a 12-month period.
No additional study visits; observation through routine care
Trial Site Locations
Total: 1 location
1
Polyclinqiue de Poitiers
Poitiers, France, 86000
Actively Recruiting
Research Team
A
Aurelia Cassany, Dr
How is the study designed?
Study Type
OBSERVATIONAL
Masking
N/A
Allocation
N/A
Model
N/A
Primary Purpose
N/A
Number of Arms
1
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