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NCT Number: NCT06768528

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.

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Key information

Conditions

Post-operative Atrial Fibrillation Cardiovascular Diseases Heart Diseases Pathologic Processes Pathological Conditions, Signs and Symptoms Post-pericardiotomy Syndrome Postoperative Complications Postpericardiotomy Syndrome

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

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

São Paulo, 05403000, Brazil

Location status: Recruiting

Location contact

Eduardo Gomes Lima, PhD

CONTACT

[email protected]

551126615352

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Galectin-3 dosage

Diagnostic Test

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

Primary outcomes

  1. Galectin-3 and post-operative atrial fibrillation

    Time frame: 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 outcomes

  1. Galectin-3 and other post-operative complications

    Time frame: 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

  2. Galectin-3 and major adverse cardiovascular events

    Time frame: 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

  3. Galectin-3 and left atrial remodeling

    Time frame: 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

Study contacts

Contact information is provided by the study sponsor or research team.

Eduardo Lima

CONTACT

[email protected]

+ 5511 26615352

Sponsors and collaborators

Lead sponsor

University of Sao Paulo General Hospital

Other

Registry information

Acronym: GNOSIS

Important dates

Study start
2023
Primary completion
2025
Study completion
2026
First posted
Jan 10, 2025
Registry last updated
Jan 10, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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