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RECRUITING

NCT06013722

Strategy for Unstable Coronary Plaque in Patients Presenting to Emergency Department for Chest Pain Suspected of Coronary Artery Disease

Sponsor: Centre Hospitalier Intercommunal de Toulon La Seyne sur Mer

View on ClinicalTrials.gov

Summary

Primary prevention of coronary disease and especially its major complication, inaugural myocardial infarction, is based on any prodromal symptoms identification and on risk profile establishment. About 50% of myocardial infarctions are caused by an unstable non-stenosing plaque, asymptomatic before the event since without significant reduction in coronary flow, particularly during a stress test or during stress imaging. Study purpose is to set up, in medical emergency department, check-up unit and cardiology department, a primary prevention strategy articulated around a routine examination: calcium scoring. The latter makes it possible to categorize patients according to their risk of generating atheromatous plaques and to classify them into several risk levels (groups) according to their score: low (\<40th percentile), intermediate (between the 40th percentile and the 65th percentile: group III) or high risk (\>65th percentile, group IV). 18F-Na PET scan can mark unstable coronary plaques. For the intermediate risk population who would demonstrate within 6 to 18 months after first calcium score either an increase of percentile of more than 20% or an increase above 20 points of the calcium score and for high risk population, 18F-Na PET scan will be recommended and repeated 6 months later. Secondary prevention treatment will then be administered in the event of an abnormal examination.

Official title: 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

Key Details

Gender

All

Age Range

18 Years - 79 Years

Study Type

INTERVENTIONAL

Enrollment

250

Start Date

2024-03-18

Completion Date

2028-03

Last Updated

2026-03-18

Healthy Volunteers

Conditions

Atherosclerosis

Interventions

DIAGNOSTIC_TEST

18F-Na PET Scan

For the intermediate risk population who would demonstrate within 6 to 18 months after first calcium score either an increase of percentile of more than 20% or an increase above 20 points of the calcium score and for high risk population, 18F-Na PET scan will be recommended and repeated 6 months later. Secondary prevention treatment will then be administered in the event of an abnormal examination.

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.

Locations (1)

Centre Hospitalier Princesse Grace

Monaco, Monaco