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

NCT ID: NCT06768528

Last Updated: 2025-01-10

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

RECRUITING

Total Enrollment

90 participants

Study Classification

OBSERVATIONAL

Study Start Date

2023-01-01

Study Completion Date

2026-12-01

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Post-operative Atrial Fibrillation Cardiovascular Diseases Post-pericardiotomy Syndrome

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Galectin-3 dosage

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

Intervention Type DIAGNOSTIC_TEST

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

University of Sao Paulo General Hospital

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Responsibility Role SPONSOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Leticia Carvalho

Role: PRINCIPAL_INVESTIGATOR

Instituto do Coração - HCFMUSP

Eduardo Lima

Role: STUDY_DIRECTOR

Instituto do Coração - HCFMUSP

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

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

São Paulo, São Paulo, Brazil

Site Status RECRUITING

Countries

Review the countries where the study has at least one active or historical site.

Brazil

Central Contacts

Reach out to these primary contacts for questions about participation or study logistics.

Eduardo Lima

Role: CONTACT

+ 5511 26615352

Facility Contacts

Find local site contact details for specific facilities participating in the trial.

Eduardo Gomes Lima, PhD

Role: primary

551126615352

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

SDC 5346/21/121

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.