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

NCT06768528 | Recruiting

• 1 other identifier: SDC 5346/21/121
• Study Type: observational
• Target: 90
• Locations: 1 country
• Sites: 1

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.

Conditions

Post-operative Atrial Fibrillation; Cardiovascular Diseases; Post-pericardiotomy Syndrome

Keywords

Post-operative atrial fibrillation; Galectin-3

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (3)

• Galectin-3 and other post-operative complications

  6 weeks

• Galectin-3 and major adverse cardiovascular events

  12 months

• Galectin-3 and left atrial remodeling

  12 months

Interventions

Galectin-3 dosage DIAGNOSTIC_TEST

Peripheral blood sample will be collected in the 24h before CABG

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

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

You may qualify if:

• Patients undergoing coronary artery bypass graft surgery

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Sao Paulo General Hospital: lead

Study Sites (1)

Instituto do Coração - Hospital das Clínicas - Faculdade de Medicina da Universidade de São Paulo

São Paulo, São Paulo, 05403000, Brazil

RECRUITING

Biospecimen

Retention: SAMPLES WITHOUT DNA

Peripheral blood sample for Galectin-3 dosage

MeSH Terms

Conditions

Cardiovascular Diseases; Postpericardiotomy Syndrome

Condition Hierarchy (Ancestors)

Heart Diseases; Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Leticia Carvalho

  Instituto do Coração - HCFMUSP

  PRINCIPAL INVESTIGATOR

• Eduardo Lima

  Instituto do Coração - HCFMUSP

  STUDY DIRECTOR

Central Study Contacts

Eduardo Lima

CONTACT

+ 5511 26615352; eduglima@yahoo.com.br

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 20, 2022
• First Posted: January 10, 2025
• Study Start: January 1, 2023
• Primary Completion: February 28, 2025
• Study Completion (Estimated): December 1, 2026
• Last Updated: January 10, 2025

Record last verified: 2024-12

Data Sharing

• IPD Sharing: Will not share

Locations

BR (1)