Status:
RECRUITING
Strategy for Unstable Coronary Plaque in Patients Presenting to Emergency Department for Chest Pain Suspected of Coronary Artery Disease
Lead Sponsor:
Centre Hospitalier Intercommunal de Toulon La Seyne sur Mer
Collaborating Sponsors:
Monaco Scientific center
Conditions:
Atherosclerosis
Eligibility:
All Genders
18-79 years
Phase:
NA
Brief 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. Abou...
Detailed Description
The purpose of this protocol is to determine the frequency and the mapping of unstable coronary plaques highlighted by 18F-Na PET in patients at intermediate and high risk, as well as their evolution ...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
March 18 2024
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
March 1 2028
Estimated Enrollment :
250 Patients enrolled
Trial Details
Trial ID
NCT06013722
Start Date
March 18 2024
End Date
March 1 2028
Last Update
November 20 2025
Active Locations (1)
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1
Centre Hospitalier Princesse Grace
Monaco, Monaco, 98000