An interventional study of 18F-Na PET Scan in Atherosclerosis, sponsored by Centre Hospitalier Intercommunal de Toulon La Seyne sur Mer. Active, not recruiting at 1 site in Monaco. Open to participants aged 18 Years to 79 Years. Per ClinicalTrials.gov, last updated 2026-07-07.
Sponsored by Centre Hospitalier Intercommunal de Toulon La Seyne sur Mer · Not applicable, Interventional, and Diagnostic
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.
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 under treatment.
Aside from traditional risk factors collection and related biological assessments, risk establishment is based on calcium score, a simple non-injected and very little irradiating scanner which measures coronary calcifications, stigmata of healed atheroma plaques and, as a rule, non-evolving. Calcium score, which is interpreted according to age, sex and ethnicity, therefore makes it possible to assign a percentile within the distribution of all the patients and to classify patients in:
Study assumptions are:
1,517 studies on the registry are indexed under Atherosclerosis; 224 are open to participants now.
This study's enrollment of 22 is below the median of 100 across 879 interventional studies indexed under Atherosclerosis.
Browse Atherosclerosis studies →Centre Hospitalier Intercommunal de Toulon La Seyne sur Mer is the lead sponsor of 78 studies on the registry; 20 are open to participants now.
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Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
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:
Exclusion Criteria:
For patients in groups III and IV:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
GFR (glomerular filtration rate) is how much blood the kidneys filter each minute. It is usually estimated from a blood test — eGFR, by formulas such as CKD-EPI or MDRD — and some studies ask for it to be measured directly instead. Usually given in mL/min/1.73 m².
Check the method, the units and the minimum the study states. A value of 90 or above is in the normal-or-high range, but kidney damage can show in other tests too.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Contraindication
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
GFR and eGFR (kidney filtering)
GFR (glomerular filtration rate) is how much blood the kidneys filter each minute. It is usually estimated from a blood test — eGFR, by formulas such as CKD-EPI or MDRD — and some studies ask for it to be measured directly instead. Usually given in mL/min/1.73 m².
Check the method, the units and the minimum the study states. A value of 90 or above is in the normal-or-high range, but kidney damage can show in other tests too.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Patients who are categorized after calcium score determination as presenting an intermediate risk to produce atheromatous plaques (group III : between the 40th percentile and the 65th percentile) or presenting a high risk to produce such plaques (group IV: \>65th percentile).
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.
Unstable coronary plaque evolution description through calcium score variation
Unstable coronary plaque evolution will be described through calcium score variation calculation.
Time frame: 8 months
Unstable coronary plaque evolution description through coro-scanner plaque size variations
Unstable coronary plaque evolution will be described through coro-scanner plaque size variations measurement
Time frame: 8 months
Unstable coronary plaque evolution description through coro-scanner plaque density variations
Unstable coronary plaque evolution will be described through coro-scanner plaque density variations measurement
Time frame: 8 months
Unstable coronary plaque evolution description through coro-scanner morphological aspect variations
Unstable coronary plaque evolution will be described through coro-scanner morphological aspect variations
Time frame: 8 months
Unstable coronary plaque evolution description through coro-scanner variations in terms of stenosis diameter
Unstable coronary plaque evolution will be described through coro-scanner variations in terms of stenosis diameter
Time frame: 8 months
Unstable coronary plaque evolution description through 18F-Na PET scan target binding variations
Unstable coronary plaque evolution will be described through 18F-Na PET scan binding variations (number of targets).
Time frame: 8 months
Unstable coronary plaque evolution description through 18F-Na PET scan binding intensity variations
Unstable coronary plaque evolution will be described through 18F-Na PET scan binding variations (SUVmax for each target).
Time frame: 8 months
Effectiveness of primary cardiovascular prevention strategy initiation by the care team
Evaluation at study end of the number of patients having entered the monitoring system, the number of patients with signs of coronary involvement and percentage of patients with coronary progression criteria.
Time frame: 24 months
Comparison of study cohort symptoms evolution to the symptoms evolution of an historical local cohort with comparable symptomatology which motivated the implementation of a "secondary prevention type" treatment
The number of persistent symptoms increasing and leading to the prescription of new tests (based on clinical management and good practices) and the number of symptoms having completely disappeared will be compared between the study cohort and the local historical one.
Time frame: 24 months
Compare, between study cohort and historical cohort, the rate of occurrence of cardiovascular events of interest
Number of following cardiovascular events will be presented: * angina proved by biology, ECG and functional and/or anatomical imaging, * coronary revascularization in the territory of the unstable plaque if it is individualized or any revascularization (angioplasty or bypass), * myocardial infarction, * occurrence of a ventricular arrhythmia, * cardiovascular death.
Time frame: 24 months
Plan to share: No
No publications or documents are linked to this record.
Ran from Mar 2024 to primary completion in Jul 2025, 16 months.
Of 177 non-industry interventional studies with no phase under Atherosclerosis, half reached primary completion within 30 months of starting (the median), counting those still running; a quarter within 17 and three quarters within 56. This study's 16 months is below that.
Counting every sponsor, half of 197 studies reached it within 30 months; a quarter within 17 and three quarters within 56.
How these figures are worked out, and which studies are left out of them.
This study is active, not recruiting, as verified in Jul 2026. You cannot join it, but the record below documents what was studied.
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Centre Hospitalier Intercommunal de Toulon La Seyne sur Mer