Assessment of Atrial Cardiomyopathy Using MRI as a Predictor of Cardiac Post-Operative Atrial Fibrillation After Cardiac Surgery. (IRM-FAPO)

April 26, 2024 updated by: Centre Hospitalier Universitaire de Saint Etienne

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.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

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 .

Study Type

Interventional

Enrollment (Estimated)

88

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • France
      • Saint-Étienne, France
        • CHU Saint-Etienne
        • Principal Investigator:
          • Jean-Baptiste Guichard, MD
        • Sub-Investigator:
          • Antoine Da Costa, MD PhD
        • Sub-Investigator:
          • Kasra Azarnoush, MD

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

16 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Diagnostic
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Coronary Artery Bypass Grafting

Patient with indication of Coronary Artery Bypass Grafting will be included. They will have:

  • before surgery : cardiac Magnetic Resonance Imaging (MRI), Blood sample
  • during surgery : Cardiac muscle biopsy
  • after surgery : Holter-electrocardiogram (ECG), medical examination
Device: cardiac Magnetic Resonance Imaging (MRI)
Cardiac magnetic resonance imaging (MRI) will be realized before Coronary Artery Bypass Grafting for assess atrial cardiomyopathy.
Other Names:
  • 4D flow Magnetic Resonance Imaging with Late Gadolinium Enhancement
Biological: Blood sample
Blood sample will be realized (4 tubes of 4ml blood, 16ml in total) before Coronary Artery Bypass Grafting.
Procedure: Cardiac muscle biopsy
Cardiac muscle biopsy will be realized during Coronary Artery Bypass Grafting.
Device: Holter-electrocardiogram (ECG)
Holter-electrocardiogram (ECG) will be realized 1 year after Coronary Artery Bypass Graftin during 3 days to diagnose the occurrence of atrial fibrillation.
Other: medical examination
medical examination will be realized 1 year after Coronary Artery Bypass Graftin. Theses datas will collected: events during the follow-up year and evaluation of the Holter-electrocardiogram result.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Analysis of the occurrence of Post-Operative Atrial Fibrillation
Time Frame: 7 days after the surgery
Measured by a continuous recording of cardiac electrical activity during 7 days after the surgery.
7 days after the surgery

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Analysis of the occurrence of Atrial Fibrillation
Time Frame: Year: 1
Analysis of the occurrence of Atrial Fibrillation evaluated during the first year post-operatively.
Year: 1
Anatomopathological parameters for the evaluation of tissue fibrosis
Time Frame: Year: 1
Analysis Anatomopathological parameters for the evaluation of tissue fibrosis evaluated by cardiac muscle biopsy.
Year: 1
Assessment of Atrial Heart Disease by cardiac Magnetic Resonance Imaging (MRI) results
Time Frame: Before the surgery
Assessment of Atrial Heart Disease by cardiac Magnetic Resonance Imaging (MRI) results to find a correlation with Post-Operative Atrial Fibrillation.
Before the surgery
Correlation between biological parameter Interleukin 1 (IL-1) and occurrence of Post-Operative Atrial Fibrillation
Time Frame: Years: 2
Measured by blood sample results.
Years: 2
Correlation between biological parameter TNF-α and occurrence of Post-Operative Atrial Fibrillation
Time Frame: Years: 2
Measured by blood sample results.
Years: 2

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Centre Hospitalier Universitaire de Saint Etienne

Investigators

  • Principal Investigator: Jean-Baptiste GUICHARD, MD, CHU Saint-Etienne

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

September 1, 2024

Primary Completion (Estimated)

August 1, 2026

Study Completion (Estimated)

August 1, 2026

Study Registration Dates

First Submitted

November 24, 2020

First Submitted That Met QC Criteria

December 1, 2020

First Posted (Actual)

December 8, 2020

Study Record Updates

Last Update Posted (Estimated)

April 29, 2024

Last Update Submitted That Met QC Criteria

April 26, 2024

Last Verified

April 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 20CH027
  • 2020-A01632-37 (Other Identifier: ANSM)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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