NCT06054360

Brief Summary

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
334

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Apr 2023

Typical duration for all trials

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 17, 2023

Completed
5 months until next milestone

First Submitted

Initial submission to the registry

September 19, 2023

Completed
7 days until next milestone

First Posted

Study publicly available on registry

September 26, 2023

Completed
2.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2025

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2025

Completed
Last Updated

October 2, 2023

Status Verified

September 1, 2023

Enrollment Period

2.5 years

First QC Date

September 19, 2023

Last Update Submit

September 28, 2023

Conditions

Keywords

coronary bypass graftingpostoperative atrial fibrillationstrainleft atrialright atrial

Outcome Measures

Primary Outcomes (1)

  • Correlation of RASr parameter variation with POAF incidence

    Correlation of RASr parameter variation with POAF incidence in patients undergoing postoperative cardiac surgery

    30 months

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-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.

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

CHU Amiens Picardie

Amiens, France

RECRUITING

MeSH Terms

Conditions

Sprains and Strains

Condition Hierarchy (Ancestors)

Wounds and Injuries

Central Study Contacts

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 19, 2023

First Posted

September 26, 2023

Study Start

April 17, 2023

Primary Completion

November 1, 2025

Study Completion

November 1, 2025

Last Updated

October 2, 2023

Record last verified: 2023-09

Data Sharing

IPD Sharing
Will not share

Locations