Cardiovascular Diseases, Post-operative Atrial Fibrillation, Post-pericardiotomy Syndrome
Conditions
Keywords
Post-operative atrial fibrillation, Galectin-3
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.
Interventions
DIAGNOSTIC_TESTGalectin-3 dosage
Peripheral blood sample will be collected in the 24h before CABG
Sponsors
University of Sao Paulo General Hospital
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Galectin-3 and post-operative atrial fibrillation | 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
| Measure | Time frame | Description |
|---|---|---|
| Galectin-3 and other post-operative complications | 6 weeks | Evaluate the association of higher levels of Galectin-3 (in ng/mL) and the occurrence of post-operative complications, such as infection, acute kidney injury, bleeding, post-pericardiotomy syndrome, reoperation, systemic embolism, type 5 myocardial infarction |
| Galectin-3 and major adverse cardiovascular events | 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 |
| Galectin-3 and left atrial remodeling | 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 |
Countries
Brazil
Contacts
PRINCIPAL_INVESTIGATORLeticia Carvalho
Instituto do Coração - HCFMUSP
STUDY_DIRECTOREduardo Lima
Instituto do Coração - HCFMUSP
Outcome results
None listed