Preventing heart attacks in patients with unstable coronary plaques
Strategy for Unstable Coronary Plaque in Patients Presenting to the Emergency Department for Chest Pain Suspected of Coronary Artery Disease. A Trial in Primary Prevention and Cardiovascular Risks Evaluation
This study is testing a new way to prevent heart attacks in patients with chest pain by using special scans to find dangerous plaque in their arteries and see how it changes with treatment.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 250 (estimated) |
| Ages | 18 Years to 79 Years |
| Sex | All |
| Sponsor | Centre Hospitalier Intercommunal de Toulon La Seyne sur Mer Academic / other |
| Locations | 1 site (Monaco) |
| Trial ID | NCT06013722 on ClinicalTrials.gov |
What this trial studies
This study aims to establish a primary prevention strategy for coronary disease in patients presenting with chest pain suspected of coronary artery disease. It utilizes calcium scoring to categorize patients based on their risk of developing atheromatous plaques, and employs 18F-Na PET scans to identify unstable coronary plaques in those at intermediate and high risk. The study will assess the frequency and mapping of these plaques and their evolution under treatment, focusing on patients who have ruled out acute coronary syndrome. The approach combines traditional risk factor assessment with advanced imaging techniques to improve patient outcomes.
Who should consider this trial
Good fit: Ideal candidates are adults aged 18 to 80 presenting to the emergency department with chest pain, where acute coronary syndrome has been ruled out.
Not a fit: Patients with a history of coronary disease, pregnant women, or those with cognitive disorders may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could significantly reduce the incidence of myocardial infarctions by identifying and managing unstable coronary plaques early.
How similar studies have performed: Other studies have shown promise in using imaging techniques for plaque identification, but this specific approach is novel.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Patient with no coronary history presenting to the emergency room, to the assessment unit or having consulted in the cardiology department for suspicious chest pain that does not allow an acute coronary syndrome or angina to be excluded and: * in whom the diagnosis of acute coronary syndrome has been ruled out on the basis of clinical, electrocardiographic, biological monitoring, or even by imaging (including coronary angiography), in accordance with recommendations and good practices * in whom effort myocardial ischemia is rendered unlikely on the basis of a clinical and paraclinical evaluation (either ergometric or by functional imaging: scintigraphy, echography or stress MRI) * wishing diagnostic care and primary prevention of coronary disease. * Age above or equal to 18 and strictly below 80 years old * Having given informed consent Exclusion Criteria: * Pregnant woman * Patient with cognitive disorders * Claustrophobic patient, or refusing radiological examinations * Patient refusing cardiological follow-up and/or treatment of his risk factors or refusing to participate in the study * Patient with contraindications or intolerances to HMG-CoA reductase inhibitors (statins) and/or Ezetimibe * Patient with liver failure * Patient with myopathy or with a history of (rhabdo)myolysis * Marked arrhythmia and in particular supraventricular or ventricular hyperexcitability, or chronic or paroxysmal atrial fibrillation not controlled by antiarrhythmic treatment * Patients with a history of sternotomy or valve replacement or metallic intracardiac probes, generators of scanner artefacts * Calcium score corresponding to the percentiles of groups I and II * For patients in groups III and IV: * renal insufficiency with glomerular filtration rate estimated by the MDRD and/or CKD-EPI formula less than or equal to 55 ml/min/1.73 m2, * known intolerance to radiological contrast products, or in whom an injected CT scan has already been performed in the 6 months preceding inclusion * Person participating in another biomedical research * Person under judicial protection (guardianship, curatorship...) * Person deprived of liberty by a judicial or administrative decision.
Where this trial is running
Monaco
- Centre Hospitalier Princesse Grace — Monaco, Monaco (Recruiting)
Study contacts
- Study coordinator: Asmaa JOBIC
- Email: asmaa.jobic@ch-toulon.fr
- Phone: 04 83 77 20 61
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.