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

ConditionsPost-operative Atrial FibrillationCardiovascular DiseasesPost-pericardiotomy Syndrome
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorUniversity of Sao Paulo General Hospital

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Patients undergoing coronary artery bypass graft surgery

Disqualifiers

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

Trial population

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

Trial design

Design model

Cohort

Time perspective

Prospective

Treatments tested in this trial

  • Galectin-3 dosage

    Diagnostic test

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

Treatment groups

No treatment groups listed

Trial outcomes

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

Time frame
Up to 7 days after surgery

Secondary outcomes

1

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

Time frame
6 weeks
2

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

Time frame
12 months
3

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

Time frame
12 months

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

University of Sao Paulo General Hospital

Lead sponsor

Source ClinicalTrials.gov
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