Post-operative Atrial FibrillationGNOSISNCT06768528
Association Between GalectiN-3 and pOSt-operative atrIal Fibrillation After Coronary Artery bypaSs Graft
An observational study of Post-operative Atrial Fibrillation and Cardiovascular Diseases, run by University of Sao Paulo General Hospital at 1 site in Brazil.
Trial 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). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Post-operative Atrial Fibrillation, Cardiovascular Diseases, Post-pericardiotomy Syndrome
- What is being tested?
- Galectin-3 dosage
- How many people
- 90 participants
- Where
- 1 siteBrazil
- Study dates
- 1 Jan 2023to Dec 2026
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Single-center cohort study with patients admitted for coronary artery bypass graft (CABG) surgery.
Who may be able to join
- Patients undergoing coronary artery bypass graft surgery
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
Brazil1 site
Instituto do Coração - Hospital das Clínicas - Faculdade de Medicina da Universidade de São Paulo
São Paulo, São Paulo, 05403000
About this study
Official title: 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.
Read the 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.
- Being tested
- Galectin-3 dosage
- Keywords
- Post-operative atrial fibrillation, Galectin-3
- Medical subject headings
- Cardiovascular Diseases, Postpericardiotomy Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Galectin-3 dosageDiagnostic test
Peripheral blood sample will be collected in the 24h before CABG
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: Up to 7 days after surgery
Secondary outcomes (3)
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, acute kidney injury, bleeding, post-pericardiotomy syndrome, reoperation, systemic embolism, type 5 myocardial infarction
Measured: 6 weeks
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
Measured: 12 months
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
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Jan 2025
- Study start1 Jan 2023
- Primary completion27 Jan 2026
- Study completionDec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Post-operative Atrial FibrillationStudies of the same condition, open and under way.
- More trials run by University of Sao Paulo General HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 90 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Sao Paulo General Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Leticia Carvalho, Principal investigator, Instituto do Coração - HCFMUSPEduardo Lima, Study director, Instituto do Coração - HCFMUSP
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06768528
- Sponsor's protocol ID
- SDC 5346/21/121
- Acronym
- GNOSIS
- Status last verified
- Feb 2026
- First submitted
- 20 Dec 2022
- Last updated
- 11 Sep 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Association Between Galectin-3 and Post-operative atrIal Fibrillation After Coronary Artery Bypass Graft
- ClinicalTrials.gov ID
- NCT06768528
- Acronym / sponsor ID
- GNOSIS / SDC 5346/21/121
- Keywords
- Post-operative atrial fibrillation, Galectin-3
- Study type
- Observational
- Recruitment status
- Active, not recruiting
- Enrolment
- 90 participants (estimated)
- Lead sponsor
- University of Sao Paulo General HospitalUniversity, hospital or other
- Study start
- 1 Jan 2023 (actual)
- Primary completion
- 27 Jan 2026 (actual)
- Study completion
- Dec 2026 (estimated)
- First posted
- 10 Jan 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Single-center cohort study with patients admitted for coronary artery bypass graft (CABG) surgery.
Key inclusion criteria (1 listed)
- Patients undergoing coronary artery bypass graft surgery
Key exclusion criteria (6 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Galectin-3 dosagePeripheral blood sample will be collected in the 24h before CABG | Diagnostic test | – |
Primary outcome
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
3 secondary outcomes
Galectin-3 and other post-operative complications
Time frame: 6 weeks
Galectin-3 and major adverse cardiovascular events
Time frame: 12 months
Galectin-3 and left atrial remodeling
Time frame: 12 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Sep 2026.
- Individual participant dataSharing planned: No
Related trials for Post-operative Atrial Fibrillation
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BoxX-NoAF Clinical Trial
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Multiparametric MRI Assessment of Atrial Heart Disease as a Predictor of Atrial Fibrillation After Myocardial Revascularization Surgery
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Leticia Carvalho principal investigator
Instituto do Coração - HCFMUSP
Eduardo Lima study director
Instituto do Coração - HCFMUSP
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Post-operative Atrial Fibrillation and Cardiovascular Diseases, run by University of Sao Paulo General Hospital at 1 site in Brazil.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 11 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Brazil. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Galectin-3 and post-operative atrial fibrillation (time frame: Up to 7 days after surgery). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Sep 2026.