Clinical trial NCT06768528: Association Between GalectiN-3 and POSt-operative AtrIal Fibrillation After Coronary Artery BypaSs Graft
Official title: Association Between Galectin-3 and Post-operative AtrIal Fibrillation After Coronary Artery Bypass Graft
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Post-operative Atrial Fibrillation
Cardiovascular Diseases
Post-pericardiotomy Syndrome
Keywords: Post-operative atrial fibrillation
Galectin-3
Lead sponsor: University of Sao Paulo General Hospital
Sponsor class: OTHER
First posted: 2025-01-10
Enrollment: 90
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Single-center cohort study with patients admitted for coronary artery bypass graft (CABG) surgery.

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.

Eligibility criteria: 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

Primary outcomes:
measure: Galectin-3 and post-operative atrial fibrillation
timeFrame: Up to 7 days after surgery
Secondary outcomes:
measure: Galectin-3 and other post-operative complications
timeFrame: 6 weeks
measure: Galectin-3 and major adverse cardiovascular events
timeFrame: 12 months
measure: Galectin-3 and left atrial remodeling
timeFrame: 12 months
Other outcomes:
Locations:
city: São Paulo
country: Brazil
facility: Instituto do Coração - Hospital das Clínicas - Faculdade de Medicina da Universidade de São Paulo
state: SP
Study officials:
affiliation: Instituto do Coração - HCFMUSP
name: Leticia Carvalho
role: PRINCIPAL_INVESTIGATOR
affiliation: Instituto do Coração - HCFMUSP
name: Eduardo Lima
role: STUDY_DIRECTOR
References: