Detecting hidden carotid and coronary plaque to find adults at very high heart-attack risk
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.
This project will test whether adding carotid ultrasound and coronary exploration to the SCORE2 risk calculator finds asymptomatic adults aged 40–79 at very high risk of heart attack better than SCORE2 alone.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 1000 (estimated) |
| Ages | 40 Years to 80 Years |
| Sex | All |
| Sponsor | Elsan Academic / other |
| Locations | 1 site (Poitiers) |
| Trial ID | NCT07252830 on ClinicalTrials.gov |
What this trial studies
This is a national, single-center, mixed retrospective and prospective observational study using routine care data to compare a strategy based on carotid and coronary explorations with the European SCORE2 risk calculation. Adults aged 40–79 referred to general cardiology with elevated LDL‑C per protocol will undergo coronary artery reserve assessment and EDTSA in a day-hospital as part of routine care. Patients with known or suspected carotid atherosclerotic disease or significant ischemic heart disease at baseline are excluded. The study will compare how many high-risk, asymptomatic individuals are identified by imaging versus SCORE2 and describe the clinical profiles of those detected.
Who should consider this trial
Good fit: Asymptomatic adults aged 40–79 seen in general cardiology with LDL‑C >1.6 g/L (or >1.3 g/L with at least one major risk factor such as smoking, hypertension, or diabetes) and no known carotid or ischemic heart disease are ideal candidates.
Not a fit: Patients with known or suspected carotid atherosclerosis or significant ischemic heart disease, those under legal protection or who refuse use of their health data, and patients unable to understand the information sheet are unlikely to benefit from participation.
Why it matters
Potential benefit: If successful, this approach could detect very high-risk individuals earlier so clinicians can intensify prevention and potentially reduce future heart attacks.
How similar studies have performed: Previous studies have shown carotid imaging and coronary imaging (including coronary calcium scoring) can improve risk prediction beyond risk scores, though the specific combination of carotid and coronary explorations versus SCORE2 in routine care is less commonly tested.
Eligibility criteria
Show full inclusion / exclusion 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
Where this trial is running
Poitiers
- Polyclinqiue de Poitiers — Poitiers, France (Recruiting)
Study contacts
- Study coordinator: Aurelia Cassany, Dr
- Email: cassany@elsan.care
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.