Ignite Creation Date:
2024-05-06 @ 7:27 PM
Last Modification Date:
2024-10-26 @ 3:07 PM
Study NCT ID:
NCT06013722
Status:
RECRUITING
Last Update Posted:
2024-07-03
First Post:
2023-07-29
Brief Title:
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
Organization:
Centre Hospitalier Intercommunal de Toulon La Seyne sur Mer
Study Overview
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
Status:
RECRUITING
Status Verified Date:
2024-07
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
SPECTRE
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 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
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
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 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
Group I absence of atheromatous plaques Score 0
Group II patients generating few plaques low risk calcium score above zero and classifying the patient below the 40th percentile of a similar population
Group III patients generating moderate plaques intermediate risk with a calcium score classifying the patient equal or above the 40th percentile and less than the 65th percentile
Group IV patients generating a lot of plaques high risk calcium score classifying the patient equal or above the 65th percentile These are more likely to be patients who will come from the cardiology check-up sector because of a higher probability of symptoms or of already being treated for primary prevention
Study assumptions are
apart from any hemodynamically significant coronary stenosis the instability of a plaque can lead to symptomatic but transient micro-thrombotic phenomena which are spontaneously or under the effect of an anti-aggregationanticoagulation resorbable Regardless of this plaque fate most frequently scarring with calcifications or much more rarely inaugural acute coronary syndrome and therefore infarction it is a major coronary event which must switch the patient from primary prevention to secondary prevention
on painful thoracic syndromes that are sufficiently suggestive to require immediately to rule out an acute coronary syndrome or secondarily myocardial ischemia angina identifying a rapid progression of the coronary involvement on the basis of calcium score or the direct demonstration of plaque instability by 18F-Na coupled with a CT scan is a major cardiovascular prevention endpoint
in patients consulting for this clinical presentation determining the frequency of those with rapid coronary evolution andor instability of coronary plaques represents a fundamental preliminary epidemiological study to modify prevention approach of primary coronary artery disease
the evaluation by non-invasive coronary imaging of secondary prevention treatment impact on these same patients initially diagnosed as rapidly progressive andor unstable would make it possible to consolidate this strategy if it proves to be effective on the basis of plaque images and clinical follow-up in terms of events
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
Group I absence of atheromatous plaques Score 0
Group II patients generating few plaques low risk calcium score above zero and classifying the patient below the 40th percentile of a similar population
Group III patients generating moderate plaques intermediate risk with a calcium score classifying the patient equal or above the 40th percentile and less than the 65th percentile
Group IV patients generating a lot of plaques high risk calcium score classifying the patient equal or above the 65th percentile These are more likely to be patients who will come from the cardiology check-up sector because of a higher probability of symptoms or of already being treated for primary prevention
Study assumptions are
apart from any hemodynamically significant coronary stenosis the instability of a plaque can lead to symptomatic but transient micro-thrombotic phenomena which are spontaneously or under the effect of an anti-aggregationanticoagulation resorbable Regardless of this plaque fate most frequently scarring with calcifications or much more rarely inaugural acute coronary syndrome and therefore infarction it is a major coronary event which must switch the patient from primary prevention to secondary prevention
on painful thoracic syndromes that are sufficiently suggestive to require immediately to rule out an acute coronary syndrome or secondarily myocardial ischemia angina identifying a rapid progression of the coronary involvement on the basis of calcium score or the direct demonstration of plaque instability by 18F-Na coupled with a CT scan is a major cardiovascular prevention endpoint
in patients consulting for this clinical presentation determining the frequency of those with rapid coronary evolution andor instability of coronary plaques represents a fundamental preliminary epidemiological study to modify prevention approach of primary coronary artery disease
the evaluation by non-invasive coronary imaging of secondary prevention treatment impact on these same patients initially diagnosed as rapidly progressive andor unstable would make it possible to consolidate this strategy if it proves to be effective on the basis of plaque images and clinical follow-up in terms of events
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None