Cardiac MRI in Front Line for the Diagnosis of Coronary Artery Disease as the Etiology of Left Ventricular Dysfunction

NCT03231189 | Completed

• 1 other identifier: AOM 16181
• Study Type: observational
• Target: 415
• Locations: 1 country
• Sites: 1

Brief Summary

When a patient is newly diagnosed of systolic dysfunction without obvious etiology (such as rhythmic, ischemic, or valvular disease), most of the time a coronary angiography is performed. In this situation, the investigators aim to evaluate a strategy with CMR as the front line exam, and invasive coronary angiography performed only in case of ischemic scar on CMR Additionally, a secondary analysis of the collected CMR images will be performed by the MIRACL.AI core lab (AP-HP, Paris) using artificial intelligence (AI) algorithms. This analysis aims to enhance the diagnostic accuracy of coronary artery disease (CAD) detection in patients with reduced left ventricular ejection fraction (rLVEF).

Conditions

Ischemic Cardiomyopathy

Keywords

Coronary artery disease; cardiac MRI; heart failure

Outcome Measures

Primary Outcomes (1)

• Sensitivity of CMR for predicting the presence of significant coronary artery stenosis on coronary angiography in patients with reduced LVEF.

  The primary endpoint is the sensitivity (and its 95% confidence interval) of CMR for the diagnosis of significant coronary artery stenosis on coronary angiography in patients with reduced LVEF. This sensitivity is the following ratio: Number of patients with an ischemic scar on CMR and a significant coronary artery stenosis on coronary angiography / Number of patients with a significant coronary artery stenosis on coronary angiography.

  up to 8 weeks

Secondary Outcomes (9)

• Evaluation of the other diagnostic performances indices of CMR for the diagnosis of angiographically significant coronary artery stenosis in patients with reduced LVEF

  up to 8 weeks

• Evaluation of the diagnostic performances of CMR for predicting angiographically significant coronary artery stenosis in patients with reduced LVEF requiring revascularization.

  up to 8 weeks

• Analysis of the concordance of CMR and coronary artery angiography in terms of coronary artery territory in patients with coronary stenosis.

  up to 8 weeks

• Additional value of CMR for the etiologic diagnosis of reduced LVEF including non-ischemic (LV non compaction, myocarditis …).

  up to 8 weeks

• Additional value of CMR for the diagnosis of complications of reduced LVEF (LV thrombus mainly).

  up to 8 weeks

Eligibility Criteria

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

Study Population

All patients referred in one of the participating centers for the etiologic assessment of an unexplained LVEF reduction will be assessed for eligibility. A trans-thoracic echocardiography will be performed in the center at the inclusion as usual, to assess LVEF and confirm the absence of obvious explanation to its reduction. Standard biological tests (included in the standard biological investigation of dilated cardiomyopathy) will be performed to exclude any contraindications to coronary angiography as usual care. They are the same as those required before CMR.

You may qualify if:

• Age ≥ 18 years
• Left Ventricular Ejection Fraction ≤ 45% on transthoracic echocardiography
• Informed signed consent
• Patient having had a preliminary clinical examination

You may not qualify if:

• Known significant coronary artery stenosis (history of myocardial infarction or coronary artery stenosis).
• Formal indication for coronary angiography other than LV dysfunction (typical angina, acute coronary syndrome, …).
• Obvious etiology for LV dysfunction (valvular, rhythmic…).
• Pregnancy or breastfeeding.
• Other contraindication for CMR (severe allergy to gadolinium known), or coronary artery angiography.
• First diagnosis of LVEF dysfunction \> 8 weeks.
• Non covered patient by the social security, the CMU
• Patients under guardianship, or unable to give consent

Sponsors & Collaborators

• Assistance Publique - Hôpitaux de Paris: lead

Study Sites (1)

Hopital Bichat Claude-Bernard

Paris, 75018, France

Location

Related Publications (1)

• Desroche LM, Darmon A, Lavie-Badie Y, Mandry D, Ducrocq G, Si-Moussi T, Durand-Zaleski I, Millischer D, Milleron O, Huttin O, Valla M, Mangin L, Farah B, Diakov C, Logeart D, Safar B, Travers JY, Mesnier J, Vappereau A, Alfaiate T, Burdet C, Jondeau G; CAMAREC investigators. Diagnostic accuracy of late gadolinium enhancement cardiac MRI for coronary artery disease in patients with reduced left ventricular ejection fraction. Heart. 2025 Sep 25;111(20):969-975. doi: 10.1136/heartjnl-2024-325419.

  PMID: 40147871 BACKGROUND

MeSH Terms

Conditions

Coronary Artery Disease; Heart Failure

Condition Hierarchy (Ancestors)

Coronary Disease; Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Arteriosclerosis; Arterial Occlusive Diseases; Vascular Diseases

Study Officials

• Guillaume Jondeau, MD,PhD

  Assistance Publique - Hôpitaux de Paris

  STUDY DIRECTOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 27, 2017
• First Posted: July 27, 2017
• Study Start: May 15, 2018
• Primary Completion: April 28, 2021
• Study Completion: August 31, 2024
• Last Updated: August 27, 2025

Record last verified: 2024-09

Data Sharing

• IPD Sharing: Will not share

Locations

FR (1)