Clinical trial NCT04657835: Assessment of Atrial Cardiomyopathy Using MRI as a Predictor of Cardiac Post-Operative Atrial Fibrillation After Cardiac Surgery.
Official title: Assessment of Atrial Cardiomyopathy Using MRI as a Predictor of Cardiac Post-Operative Atrial Fibrillation After Cardiac Surgery.
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Coronary Artery Bypass Grafting
Keywords: Post Operative Atrial Fibrillation
magnetic resonance imaging
Coronary Artery Bypass Grafting (CABG)
Lead sponsor: Centre Hospitalier Universitaire de Saint Etienne
Sponsor class: OTHER
First posted: 2020-12-08
Enrollment: 88
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

Brief summary: After cardiac surgery, there is a high prevalence of postoperative atrial fibrillation (POAF). However, its diagnostic and therapeutic management is poorly codified.

This pathology is caused by atrial abnormalities which form the concept of atrial cardiomyopathy.

New tools affording to itemize the atrial cardiomyopathy are needed. Indeed, current tools, as echocardiography and electrocardiogram are relevant but only lead to a raw evaluation of the atrial cardiomyopathy. MRI, because of the assessment of the atrial fibrosis by late gadolinium assessment (LGE) and 4D flow magnetic resonance imaging (MRI) could be relevant to specify the atrial cardiomyopathy.

Detailed description: The aim of the study is to evaluate the atrial cardiomyopathy, assessed by magnetic resonance imaging (MRI), as a predictor of postoperative atrial fibrillation (POAF) after with coronary artery bypass graft surgery .

Eligibility criteria: Inclusion Criteria:

* Age ≥ 18 years
* Indication for surgical myocardial revascularization by coronary artery bypass
* Patient affiliated or entitled to a social security scheme
* Informed consent for participation in the study

Exclusion Criteria:

* Contraindication to cardiac MRI (Severe Kidney disease, Allergy to gadoliniumn, ...)
* History of Atriale Fibrillation (AF)
* Indication of cardiac valve surgery concomitantly with Coronary Artery Bypass Grafting (CABG).
* pregnant or breast-feeding women

Primary outcomes:
measure: Analysis of the occurrence of Post-Operative Atrial Fibrillation
timeFrame: 7 days after the surgery
Secondary outcomes:
measure: Analysis of the occurrence of Atrial Fibrillation
timeFrame: Year: 1
measure: Anatomopathological parameters for the evaluation of tissue fibrosis
timeFrame: Year: 1
measure: Assessment of Atrial Heart Disease by cardiac Magnetic Resonance Imaging (MRI) results
timeFrame: Before the surgery
measure: Correlation between biological parameter Interleukin 1 (IL-1) and occurrence of Post-Operative Atrial Fibrillation
timeFrame: Years: 2
measure: Correlation between biological parameter TNF-α and occurrence of Post-Operative Atrial Fibrillation
timeFrame: Years: 2
Other outcomes:
Locations:
city: Saint-Étienne
country: France
facility: CHU Saint-Etienne
Study officials:
affiliation: CHU SAINT-ETIENNE
name: Jean-Baptiste GUICHARD, MD
role: PRINCIPAL_INVESTIGATOR
References: