Association Between GalectiN-3 and POSt-operative AtrIal Fibrillation After Coronary Artery BypaSs Graft

Recruiting

• Conditions: Post-operative Atrial Fibrillation; Cardiovascular Diseases; Post-pericardiotomy Syndrome

• Registration Number: NCT06768528
• Lead Sponsor: University of Sao Paulo General Hospital

Brief Summary

The goal of this observational study is to test the association between high levels of Galectin-3 and the occurrence of post-operative atrial fibrillation after isolated coronary artery bypass grafting (CABG). The main question\[s\] it aims to answer are:

* Is Galectin-3 an accurate biomarker to predict higher risk of developing post-operative atrial fibrillation?

* Are high levels of Galectin-3 associated to other post-operative complications and major adverse cardiovascular events? Participants will be enrolled during pre-operative evaluation and a peripheral blood sample collection will be performed in the 24h before CABG. Participants will then be followed for a period of 12 months (daily during hospitalization and 3 appointments after hospital discharge) to determine whether patients with higher levels of Galectin-3 will have worse outcomes.

Detailed Description

Prospective, observational, single-center cohort study including patients undergoing coronary artery bypass graft (CABG) surgery.

Patients will be enrolled during preoperative evaluation. A peripheral blood sample will be collected within 24 hours before surgery and patients will be followed during hospitalization and for 12 months after discharge.

Study Timeline

• Study First Submitted: 2022-12-20
• Study Start: 2023-01-01
• Status Verified: 2024-12
• Study First Submitted QC: 2025-01-06
• Last Update Submitted: 2025-01-06
• Study First Posted: 2025-01-10
• Last Update Posted: 2025-01-10
• Primary Completion: 2025-02-28
• Study Completion: 2026-12-01

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 90

Inclusion Criteria

• Patients undergoing coronary artery bypass graft surgery

Exclusion Criteria

• Inability to sign the free and informed consent form
• Renal dysfunction with estimated glomerular filtration rate less than 30ml / min / 1.73m² or dialysis therapy
• Moderate to severe left ventricular dysfunction (ejection fraction < 40%)
• Patients with previous atrial fibrillation
• Pregnancy
• Concomitant valve surgery

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Galectin-3 and post-operative atrial fibrillation	Up to 7 days after surgery	Evaluate the association of higher levels of Galectin-3 (in ng/mL) and the occurrence of post-operative atrial fibrillation lasting at least 12 hours or requiring cardioversion

Secondary Outcome Measures

Name	Time	Method
Galectin-3 and other post-operative complications	6 weeks	Evaluate the association of higher levels of Galectin-3 (in ng/mL) and the occurrence of post-operative complications, such as infection, bleeding, post-pericardiotomy syndrome, reoperation, systemic embolism, type 5 myocardial infarction
Galectin-3 and major adverse cardiovascular events	12 months	Evaluate the association of higher levels of Galectin-3 (in ng/mL) and the occurrence major adverse cardiovascular events, such as stroke, acute coronary syndrome, revascularization procedures and cardiovascular death
Galectin-3 and left atrial remodeling	12 months	Evaluate the association of higher levels of Galectin-3 (in ng/mL) and left atrial enlargement (both linear and volumetric echocardiographic measurements) and development of supraventricular arrhythmias in holter monitoring

Trial Locations

Locations (1)

Instituto do Coração - Hospital das Clínicas - Faculdade de Medicina da Universidade de São Paulo; 🇧🇷 São Paulo, SP, Brazil