Strategy for Unstable Coronary Plaque in Patients Presenting to Emergency Department for Chest Pain Suspected of Coronary Artery Disease

NCT06013722 | Active Not Recruiting

• 1 other identifier: 2023-CHITS-007
• Study Type: interventional
• Target: 22
• Locations: 1 country
• Sites: 1

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.

Conditions

Atherosclerosis

Keywords

Atherosclerotic plaques; Acute coronary syndrome; 18F-Na PET; Coronary Artery Calcification Score

Outcome Measures

Primary Outcomes (7)

• Unstable coronary plaque evolution description through calcium score variation

  Unstable coronary plaque evolution will be described through calcium score variation calculation.

  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

  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

  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

  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

  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).

  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).

  8 months

Secondary Outcomes (3)

• Effectiveness of primary cardiovascular prevention strategy initiation by the care team

  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

  24 months

• Compare, between study cohort and historical cohort, the rate of occurrence of cardiovascular events of interest

  24 months

Study Arms (1)

Patients of groups III and IV

EXPERIMENTAL

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

Interventions

18F-Na PET Scan DIAGNOSTIC_TEST

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.

Patients of groups III and IV

Eligibility Criteria

• Age: 18 Years - 79 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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 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,
• Person participating in another biomedical research
• Person under judicial protection (guardianship, curatorship...)
• Person deprived of liberty by a judicial or administrative decision.

Sponsors & Collaborators

• Centre Hospitalier Intercommunal de Toulon La Seyne sur Mer: lead
• Monaco Scientific center: collaborator

Study Sites (1)

Centre Hospitalier Princesse Grace

Monaco, 98000, Monaco

Location

MeSH Terms

Conditions

Atherosclerosis; Plaque, Atherosclerotic; Acute Coronary Syndrome

Condition Hierarchy (Ancestors)

Arteriosclerosis; Arterial Occlusive Diseases; Vascular Diseases; Cardiovascular Diseases; Pathological Conditions, Anatomical; Pathological Conditions, Signs and Symptoms; Myocardial Ischemia; Heart Diseases

Study Officials

• Yann-Erick CLAESSENS, MD-PhD

  Centre Hospitalier Princesse Grace

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 29, 2023
• First Posted: August 28, 2023
• Study Start: March 18, 2024
• Primary Completion (Estimated): November 1, 2026
• Study Completion (Estimated): March 1, 2028
• Last Updated: April 13, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will not share

Locations

MO (1)