SPECTRE: 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 (Other)

Overall Status

Not yet recruiting

CT.gov ID

NCT06013722

Collaborator

Monaco Scientific center (Other)

250

Enrollment

Location

Arm

Anticipated Duration (Months)

5.2

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Atherosclerosis	Diagnostic Test: 18F-Na PET Scan	N/A

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-aggregation/anticoagulation) 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 and/or instability of coronary plaque(s) 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" and/or 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 Design

Study Type:

Interventional

Anticipated Enrollment :

250 participants

Allocation:

N/A

Intervention Model:

Single Group Assignment

Masking:

None (Open Label)

Primary Purpose:

Diagnostic

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

Anticipated Study Start Date :

Dec 1, 2023

Anticipated Primary Completion Date :

Aug 1, 2026

Anticipated Study Completion Date :

Dec 1, 2027

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Patients of groups III and IV 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.

Arm

Intervention/Treatment

Experimental: Patients of groups III and IV

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.

Outcome Measures

Primary Outcome Measures

Unstable coronary plaque evolution description [8 months]
Unstable coronary plaque evolution will be described through calcium score variation.
Unstable coronary plaque evolution description [8 months]
Unstable coronary plaque evolution will be described through coro-scanner anatomical variations (targets, sizes, density, remodeling and morphological aspect, surface and diameter of stenosis).
Unstable coronary plaque evolution description [8 months]
Unstable coronary plaque evolution will be described through 18F-Na PET scan binding variations (targets, SUVmax and SUVmax ratio on blood activity).

Secondary Outcome Measures

Effectiveness of primary cardiovascular prevention strategy initiation by the care team [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.
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 [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.
Compare, between study cohort and historical cohort, the rate of occurrence of cardiovascular events of interest [24 months]
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.

Eligibility Criteria

Criteria

Ages Eligible for Study:

46 Years to 79 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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 strictly above 45 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 preventive anti-aggregation (aspirin 75 to 100 mg/day),
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 a 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.