Predictive Value of Right Atrial Strain in Postoperative Atrial Fibrillation in Patients Undergoing Cardiac Surgery (ODFAPO)

September 28, 2023 updated by: Centre Hospitalier Universitaire, Amiens

The incidence of postoperative atrial fibrillation (POAF) after cardiac surgery is around 30%. POAF increases the risk of developing permanent atrial fibrillation and raises the risk of cardiac decompensation, stroke, acute myocardial infarction, and death. While the role of the left atrium (LAF) in the pathophysiology of POAF is now well-established, the part of the right atrium (RA) remains poorly understood. Recent studies suggest a correlation between RA function and POAF.

RA function can be assessed by transthoracic echocardiography (TTE) with dedicated software for measuring the RA strain (RAS). RA function is thus divided into three phases: reservoir (RASr), conduit, and contraction. Numerous studies have demonstrated that a significant alteration in RAS predicts POAF in various clinical contexts. Therefore, it is essential to investigate whether alterations in RA function assessed by 2D-STE (RAS) are associated with an increased occurrence of FAPO after cardiac surgery.

It is essential to investigate whether alterations in RA function assessed by 2D-STE (RAS) are associated with an increased occurrence of FAPO after cardiac surgery.

Study Overview

Status

Recruiting

Conditions

Study Type

Observational

Enrollment (Estimated)

334

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 Locations

  • France
      • Amiens, France
        • Recruiting
        • Chu Amiens Picardie
        • Sub-Investigator:
          • Christophe BEYLS, MD
        • Contact:

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

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

This prospective, single-center study was conducted at the Amiens University Hospital. As an additional procedure to the patient's management, it includes the systematic performance of a TTE the day before the surgery, with the acquisition of specific views to measure RAS. After enrollment, the principal investigator will perform a TTE to measure RASr on particular views. TTE will be performed in a supine position at the patient's bedside by a trained medical operator, following a standardized protocol. After surgery, the patient will be monitored by a 5-lead ECG to diagnose POAF. The maximum duration of POAF monitoring will be seven days in the intensive care unit.

Description

Inclusion Criteria:

  • Adult patient (>18 years old)
  • The patient was hospitalized at the Amiens University Hospital for scheduled aortocoronary bypass grafting under cardiopulmonary bypass.
  • Echocardiographic image quality enabling the measurement of RAS parameters
  • Patient affiliation to a social security scheme
  • Patient/proxy information and collection of their non-opposition.

Exclusion Criteria:

  • Patients participating in an interventional study may modify the incidence of POAF.
  • History of atrial fibrillation or flutter.
  • Valvular and ascending aorta cardiac surgery
  • Urgent cardiac surgery.
  • Presence of tricuspid insufficiency greater than grade 2.
  • Left ventricular ejection fraction lower than 50%.
  • Patient receiving circulatory mechanical assistance before surgery.
  • Dependency on ventricular and atrial pacing by an internal or external cardiac pacemaker during the echocardiographic examination.

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Correlation of RASr parameter variation with POAF incidence
Time Frame: 30 months
Correlation of RASr parameter variation with POAF incidence in patients undergoing postoperative cardiac surgery
30 months

Collaborators and Investigators

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

Sponsor

Centre Hospitalier Universitaire, Amiens

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 (Actual)

April 17, 2023

Primary Completion (Estimated)

November 1, 2025

Study Completion (Estimated)

November 1, 2025

Study Registration Dates

First Submitted

September 19, 2023

First Submitted That Met QC Criteria

September 19, 2023

First Posted (Actual)

September 26, 2023

Study Record Updates

Last Update Posted (Actual)

October 2, 2023

Last Update Submitted That Met QC Criteria

September 28, 2023

Last Verified

September 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • PI2023_843_0048

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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