Strategy for Unstable Coronary Plaque in Patients Presenting to Emergency Department for Chest Pa… (NCT06013722) | Clinical Trial Compass
Active — Not RecruitingNot Applicable
Strategy for Unstable Coronary Plaque in Patients Presenting to Emergency Department for Chest Pain Suspected of Coronary Artery Disease
Monaco22 participantsStarted 2024-03-18
Plain-language 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.
Who can participate
Age range
18 Years – 79 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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 antiarrhythm…
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1This trial uses CT coronary scans and a special PET scan with a radioactive tracer called 18F-Sodium Fluoride to track unstable plaque over time — what does that radiation exposure mean for me specifically, and is it safe given my current health situation?
2Since this trial is listed as 'active, not recruiting,' does that mean enrollment is already closed, and if so, are there similar studies looking at unstable coronary plaque that I might still be eligible for?
3The trial seems focused on describing and measuring how unstable plaque changes rather than testing a new treatment — so if I were involved, would my actual care and treatment decisions be affected in any way, or would this be purely observational?
4This study is measuring things like plaque density, size, and calcium score changes on multiple scans — how many follow-up visits or imaging sessions would that typically involve, and is that kind of schedule realistic for someone managing chest pain day to day?
5Given that this trial is about better understanding unstable plaque rather than offering a new therapy, should I be focusing first on established treatments for coronary artery disease, and how would participation in a study like this fit alongside those standard options?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Unstable coronary plaque evolution description through calcium score variation
Timeframe: 8 months
2
Unstable coronary plaque evolution description through coro-scanner plaque size variations
Timeframe: 8 months
3
Unstable coronary plaque evolution description through coro-scanner plaque density variations
Timeframe: 8 months
4
Unstable coronary plaque evolution description through coro-scanner morphological aspect variations
Timeframe: 8 months
5
Unstable coronary plaque evolution description through coro-scanner variations in terms of stenosis diameter
Timeframe: 8 months
6
Unstable coronary plaque evolution description through 18F-Na PET scan target binding variations
Timeframe: 8 months
7
Unstable coronary plaque evolution description through 18F-Na PET scan binding intensity variations
Trial details
NCT IDNCT06013722
SponsorCentre Hospitalier Intercommunal de Toulon La Seyne sur Mer