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

Association Between Galectin-3 and Post-operative AtrIal Fibrillation After Coronary Artery Bypass Graft

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.

Study Overview

• Status: Recruiting
• Conditions: Cardiovascular Diseases; Post-operative Atrial Fibrillation; Post-pericardiotomy Syndrome
• Intervention / Treatment: Diagnostic test: Galectin-3 dosage

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 Type: Observational
• Enrollment (Estimated): 90

Contacts and Locations

• Study Contact: Name: Eduardo Lima; Phone Number: + 5511 26615352; Email: eduglima@yahoo.com.br

Study Locations

• Brazil
  • SP
    • São Paulo, SP, Brazil, 05403000
      • Recruiting
      • Instituto do Coração - Hospital das Clínicas - Faculdade de Medicina da Universidade de São Paulo
      • Contact: Eduardo Gomes Lima, PhD; Phone Number: 551126615352; Email: eduglima@yahoo.com.br

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

Single-center cohort study with patients admitted for coronary artery bypass graft (CABG) surgery.

Description

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 Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Galectin-3 and post-operative atrial fibrillation	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	Up to 7 days after surgery

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Galectin-3 and other post-operative complications	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	6 weeks
Galectin-3 and major adverse cardiovascular events	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	12 months
Galectin-3 and left atrial remodeling	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	12 months

Collaborators and Investigators

• Sponsor: University of Sao Paulo General Hospital
• Investigators: Principal Investigator: Leticia Carvalho, Instituto do Coracao - HCFMUSP; Study Director: Eduardo Lima, Instituto do Coracao - HCFMUSP

Study record dates

Study Major Dates

• Study Start (Actual): January 1, 2023
• Primary Completion (Estimated): February 28, 2025
• Study Completion (Estimated): December 1, 2026

Study Registration Dates

• First Submitted: December 20, 2022
• First Submitted That Met QC Criteria: January 6, 2025
• First Posted (Actual): March 25, 2025

Study Record Updates

• Last Update Posted (Actual): March 25, 2025
• Last Update Submitted That Met QC Criteria: January 6, 2025
• Last Verified: December 1, 2024

More Information

Terms related to this study

• Keywords: Post-operative atrial fibrillation; Galectin-3
• Additional Relevant MeSH Terms: Postoperative Complications; Pathologic Processes; Heart Diseases; Arrhythmias, Cardiac; Cardiovascular Diseases; Atrial Fibrillation; Postpericardiotomy Syndrome
• Other Study ID Numbers: SDC 5346/21/121

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
• product manufactured in and exported from the U.S.: No