Centre Hospitalier Princesse Grace
Monaco, 98000
NCT Number: NCT06013722
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.
This study is active but is not currently recruiting participants.
18 year–79 year
All sexes
Interventional
Not applicable
Monaco, 98000
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:
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
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.
Time frame: 8 months
Unstable coronary plaque evolution will be described through calcium score variation calculation.
Time frame: 8 months
Unstable coronary plaque evolution will be described through coro-scanner plaque size variations measurement
Time frame: 8 months
Unstable coronary plaque evolution will be described through coro-scanner plaque density variations measurement
Time frame: 8 months
Unstable coronary plaque evolution will be described through coro-scanner morphological aspect variations
Time frame: 8 months
Unstable coronary plaque evolution will be described through coro-scanner variations in terms of stenosis diameter
Time frame: 8 months
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 will be described through 18F-Na PET scan binding variations (SUVmax for each target).
Time frame: 24 months
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
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
Number of following cardiovascular events will be presented:
Centre Hospitalier Intercommunal de Toulon La Seyne sur Mer
Other
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
Acronym: SPECTRE
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View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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