NCT03231189Completed
Cardiac MRI in Front Line for the Diagnosis of Coronary Artery Disease as the Etiology of Left Ventricular Dysfunction
Prospective Multicentric Study for the Diagnostic Performance of CArdiac MAgnetic REsonance Imaging Used First for the Diagnosis of Coronary Artery Disease as the Etiology of Left Ventricular Dysfunction
Source: ClinicalTrials.gov · Last updated 27 Aug 2025
Brief summary (registry, in English)
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).
- Status (registry)
- Completed
- Study type
- Observational
- Enrollment
- 415 (actual)
- First submitted
- 27 Jun 2017
- Start date
- 15 May 2018
- Primary completion date
- 28 Apr 2021
- Lead sponsor
- Assistance Publique - Hôpitaux de Paris
- Diseases
- Heart failure, Coronary artery disease
- NCT number
- NCT03231189
What you commit to
- Study type: Observational
- Participants enrolled: 415
- From 15 May 2018 to the primary completion date, 28 Apr 2021
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Other illness
- 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, …).
- Other contraindication for CMR (severe allergy to gadolinium known), or coronary artery angiography.
Lab values
- First diagnosis of LVEF dysfunction \> 8 weeks.
Other
- Obvious etiology for LV dysfunction (valvular, rhythmic…).
- Pregnancy or breastfeeding.
- Non covered patient by the social security, the CMU
- Patients under guardianship, or unable to give consent
Who the study is looking for
- Age ≥ 18 years
- Left Ventricular Ejection Fraction ≤ 45% on transthoracic echocardiography
- Informed signed consent
- Patient having had a preliminary clinical examination
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Hôpital Bichat - Claude-Bernard Coordinator of this site? Confirm its status | Paris | France | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.