Atrial FibrillationCBP-VRNCT06256965
Cardiopulmonary Bypass and Ventricular Remodeling
An observational study of Atrial Fibrillation and Heart Failure, run by University of Chile at 1 site in Chile.
Trial summary
The goal of this observational study is determine if reduced ventricular ejection fraction is a factor that determines a pro-oxidant imbalance in patients subjected to cardiac surgery with cardiopulmonary bypass. The main questions are: 1. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Atrial Fibrillation, Heart Failure
- What is being tested?
- Detection of peri-operative atrial fibrillation
- How many people
- 12 participants
- Where
- 1 siteChile
- Study dates
- 4 Oct 2021to 13 Jun 2022
- How long will I take part?
- 9 Months
- Phase
- Observational
- Are there results?
- None posted in the registry
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: A prospective study was conducted in patients referred to the Cardiac Surgery De-partment from the National Thoracic Institute from Santiago, Chile, between October to December 2021, inclusively. The follow-up includes 2 groups: i) patients with preserved LVEF (pLVEF, n=7) and ii) patients with reduced LVEF (rLVEF, n=5).
Who may be able to join
- age ≥18 years, chronic heart failure (WHO-functional class II, III) for at least 3 months before surgery. At the baseline visit, 7-10 days before surgery, the patients were classified by echocardiography as HF with pLVEF (LVEF >40%) or HF with rLVEF (LVEF ≤40%).
Who cannot join
- Patients with history or evidence of AF, previous myocardial infarction, current use of amiodarone, severe congestive heart failure (New York Heart Association class III or IV), presence of prosthetic valves, congenital valvular disease, chronic rheumatic, neoplastic diseases, liver insufficiency, severe chronic kidney disease (serum creatinine >2.5 mg/dl), recent infections ( 2 weeks) and emergency surgery or repair of cyanotic heart disease.
- In addition, patients receiving nonsteroidal anti-inflammatory drugs, corticosteroids, antioxidants, vitamins, or fish oil supplements, three months before surgery were also excluded.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Left Ventricular Ejection Fraction and Oxidative Stress Markers in Patients Subjected to Car-diac Surgery With Cardiopulmonary Bypass
The goal of this observational study is determine if reduced ventricular ejection fraction is a factor that determines a pro-oxidant imbalance in patients subjected to cardiac surgery with cardiopulmonary bypass.
The main questions are:
- 1. Preoperative reduced left ventricular function determines higher blood and atrial tissue oxidative stress in patients subjected to cardiopulmonary bypass
- 2. Oxidative stress markers in atrial tissue of cardiac surgical patients with develop atrial fibrillation The main tasks participants will be asked to do is register the symptoms of arrhythmia and heart failure. Also, obtain a electrocardiographic register if any present palpitations or chest pain with clinical significance This study not present a comparison group.
Read the detailed description
- Atrial fibrillation detection: continuous ECG monitoring was performed 24 to 48 h after CBP. Whenever arrhythmia symptoms occurred, a 12-lead ECG was performed every 12 h for 5 days. The presence of ECG-documented atrial fibrillation for at least 1 min was considered as a postoperative atrial fibrillation event.
- Samples and Biopsies: All patients were subjected to the same surgical procedure, including the same induction and anesthesia protocol, and the execution by the same medical team. Surgical access was via a median sternotomy incision, and all anastomoses were sutured by hand. Protection of myocardial tissue was accomplished with crystalloid cold potassium cardioplegic solution. In cardiac surgery, at the time of pericardiocentesis, samples of right appendage (approximately 200mg) were obtained immediately before starting extracorporeal circulation. They were immediately frozen in liquid nitrogen and stored at -80°C. Blood samples were collected in chilled vacutainers containing 4 mM disodium EDTA and centrifuged at 3000 × g for 10 min. Plasma samples from each patient were stored at -80°C until performing the biochemical determinations.
- Pre-operative Echocardiographic images: All echocardiographic analyses were performed at the Echocardiography Unit of the National Thorax Institute using GE Vivid E9 equipment at the baseline visit (7 days before surgery). The strain analyses were performed using a semi-automated speckle tracking technique (EchoPAC, GE Medical Systems, Milwaukee, Wisconsin) using a model of the entire LV (the 3 apical views). Inadequately tracked segments were excluded. A 3D full-volume acquisition of the LV using a matrix array transducer with the highest possible volume rate was be attempted in all patients. LV volumes and LVEF were measured offline (3DLVQ, EchoPAC, GE Medical Systems, Milwaukee, Wisconsin), with an abnormal LVEF identified as <40 %.
- Biochemical parameters of oxidative stress. Determinations in plasma and atrial tissue samples (obtained during cardiac surgery, at the time of pericardiocentesis) and treated under the same experimental conditions.
- Conditions
- Atrial Fibrillation, Heart Failure
- Being tested
- Detection of peri-operative atrial fibrillation
- Keywords
- left ventricular ejection fraction, oxidative stress, cardiopulmonary bypass, atrial tissue
- Medical subject headings
- Atrial Fibrillation, Heart Failure
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Detection of peri-operative atrial fibrillationDiagnostic test
Also called Detection of oxidative stress markers of protein and lipid peroxidation
atrial tissue and plasma from patients with atrial fibrillation detection were analyzed for determine lipid and protein oxidation, and detect markers of myocardial injury.
| Study group | Role | What they receive |
|---|---|---|
| patients with present reduced left ventricular ejection fraction | patients with preoperatively shows in echocardiographic parameters LVEF lower 40%. Receives: Diagnostic Test: Detection of peri-operative atrial fibrillation | |
| patients with present preserved left ventricular ejection fraction | patients with preoperatively shows in echocardiographic parameters LVEF higher 40%. Receives: Diagnostic Test: Detection of peri-operative atrial fibrillation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Postoperative atrial fibrillation
The presence of ECG-documented atrial fibrillation for at least 1 min was considered as a postoperative atrial fibrillation event.
Measured: cardiac recording monitoring from surgery until the fifth postoperative day
Secondary outcomes (1)
Oxidative stress markers
Tissue and plasma lipid peroxidation were measured as TBARS and 8-isoprostanes levels. Nitrotyrosine levels were detect in atrial tissue from show an oxidation of proteins
Measured: Samples obtained at surgical time and on fourty eight hours from surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Feb 2024
- Study start4 Oct 2021
- Primary completion15 Nov 2021
- Study completion13 Jun 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (8)Papers the sponsor has linked to this study.
- Other trials for Atrial FibrillationStudies of the same condition, open and under way.
- 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
- Cross-sectional
- Enrolment
- 12 participants (actual)
- Target duration
- 9 Months
Sponsor and investigators
- Lead sponsor
- University of Chile
- Sponsor type
- University, hospital or other
- Collaborators
- Hospital del Salvador
- Responsible party
- Principal investigator, RODRIGO CASTILLO, University of Chile
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06256965
- Sponsor's protocol ID
- CBA180619
- Acronym
- CBP-VR
- Status last verified
- Feb 2024
- First submitted
- 5 Feb 2024
- Last updated
- 13 Feb 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Noubiap JJ, Sanders P, Nattel S, Lau DH. Biomarkers in Atrial Fibrillation: Pathogenesis and Clinical Implications. Card Electrophysiol Clin. 2021 Mar;13(1):221-233. doi: 10.1016/j.ccep.2020.10.006.
PubMed 33516400Thavendiranathan P, Negishi T, Somerset E, Negishi K, Penicka M, Lemieux J, Aakhus S, Miyazaki S, Shirazi M, Galderisi M, Marwick TH; SUCCOUR Investigators. Strain-Guided Management of Potentially Cardiotoxic Cancer Therapy. J Am Coll Cardiol. 2021 Feb 2;77(4):392-401. doi: 10.1016/j.jacc.2020.11.020. Epub 2020 Nov 18.
PubMed 33220426Benzie IF, Strain JJ. The ferric reducing ability of plasma (FRAP) as a measure of "antioxidant power": the FRAP assay. Anal Biochem. 1996 Jul 15;239(1):70-6. doi: 10.1006/abio.1996.0292.
PubMed 8660627Szymczyk G, Beltowski J, Marciniak A, Kotarski J. Serum isoprostanes levels in patients after abdominal hysterectomy. Rocz Akad Med Bialymst. 2005;50:322-4.
PubMed 16358993Gutierrez-Camacho LR, Kormanovski A, Del Carmen Castillo-Hernandez M, Guevara-Balcazar G, Lara-Padilla E. Alterations in glutathione, nitric oxide and 3-nitrotyrosine levels following exercise and/or hyperbaric oxygen treatment in mice with diet-induced diabetes. Biomed Rep. 2020 May;12(5):222-232. doi: 10.3892/br.2020.1291. Epub 2020 Mar 11.
PubMed 32257185Farias JG, Herrera EA, Carrasco-Pozo C, Sotomayor-Zarate R, Cruz G, Morales P, Castillo RL. Pharmacological models and approaches for pathophysiological conditions associated with hypoxia and oxidative stress. Pharmacol Ther. 2016 Feb;158:1-23. doi: 10.1016/j.pharmthera.2015.11.006. Epub 2015 Nov 23.
PubMed 26617218Xu Y, Guo W, Zeng D, Fang Y, Wang R, Guo D, Qi B, Xue Y, Xue F, Jin Z, Li Y, Zhang M. Inhibiting miR-205 Alleviates Cardiac Ischemia/Reperfusion Injury by Regulating Oxidative Stress, Mitochondrial Function, and Apoptosis. Oxid Med Cell Longev. 2021 Jun 29;2021:9986506. doi: 10.1155/2021/9986506. eCollection 2021.
PubMed 34306321Farias JG, Molina VM, Carrasco RA, Zepeda AB, Figueroa E, Letelier P, Castillo RL. Antioxidant Therapeutic Strategies for Cardiovascular Conditions Associated with Oxidative Stress. Nutrients. 2017 Sep 1;9(9):966. doi: 10.3390/nu9090966.
PubMed 28862654
Study at a glance
From the registry record, last updated by the sponsor on 13 Feb 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Left Ventricular Ejection Fraction and Oxidative Stress Markers in Patients Subjected to Car-diac Surgery With Cardiopulmonary Bypass
- ClinicalTrials.gov ID
- NCT06256965
- Acronym / sponsor ID
- CBP-VR / CBA180619
- Conditions
- Atrial Fibrillation, Heart Failure
- Keywords
- left ventricular ejection fraction, oxidative stress, cardiopulmonary bypass, atrial tissue
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 12 participants (actual)
- Lead sponsor
- University of ChileUniversity, hospital or other
- Collaborators
- Hospital del Salvador
- Study start
- 4 Oct 2021 (actual)
- Primary completion
- 15 Nov 2021 (actual)
- Study completion
- 13 Jun 2022 (actual)
- First posted
- 13 Feb 2024 (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 determine if reduced ventricular ejection fraction is a factor that determines a pro-oxidant imbalance in patients subjected to cardiac surgery with cardiopulmonary bypass.
The main questions are:
- 1. Preoperative reduced left ventricular function determines higher blood and atrial tissue oxidative stress in patients subjected to cardiopulmonary bypass
- 2. Oxidative stress markers in atrial tissue of cardiac surgical patients with develop atrial fibrillation The main tasks participants will be asked to do is register the symptoms of arrhythmia and heart failure. Also, obtain a electrocardiographic register if any present palpitations or chest pain with clinical significance This study not present a comparison group.
Detailed description
- Atrial fibrillation detection: continuous ECG monitoring was performed 24 to 48 h after CBP. Whenever arrhythmia symptoms occurred, a 12-lead ECG was performed every 12 h for 5 days. The presence of ECG-documented atrial fibrillation for at least 1 min was considered as a postoperative atrial fibrillation event.
- Samples and Biopsies: All patients were subjected to the same surgical procedure, including the same induction and anesthesia protocol, and the execution by the same medical team. Surgical access was via a median sternotomy incision, and all anastomoses were sutured by hand. Protection of myocardial tissue was accomplished with crystalloid cold potassium cardioplegic solution. In cardiac surgery, at the time of pericardiocentesis, samples of right appendage (approximately 200mg) were obtained immediately before starting extracorporeal circulation. They were immediately frozen in liquid nitrogen and stored at -80°C. Blood samples were collected in chilled vacutainers containing 4 mM disodium EDTA and centrifuged at 3000 × g for 10 min. Plasma samples from each patient were stored at -80°C until performing the biochemical determinations.
- Pre-operative Echocardiographic images: All echocardiographic analyses were performed at the Echocardiography Unit of the National Thorax Institute using GE Vivid E9 equipment at the baseline visit (7 days before surgery). The strain analyses were performed using a semi-automated speckle tracking technique (EchoPAC, GE Medical Systems, Milwaukee, Wisconsin) using a model of the entire LV (the 3 apical views). Inadequately tracked segments were excluded. A 3D full-volume acquisition of the LV using a matrix array transducer with the highest possible volume rate was be attempted in all patients. LV volumes and LVEF were measured offline (3DLVQ, EchoPAC, GE Medical Systems, Milwaukee, Wisconsin), with an abnormal LVEF identified as <40 %.
- Biochemical parameters of oxidative stress. Determinations in plasma and atrial tissue samples (obtained during cardiac surgery, at the time of pericardiocentesis) and treated under the same experimental conditions.
Study design
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Target follow-up
- 9 Months
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| patients with present reduced left ventricular ejection fraction | – | Diagnostic Test: Detection of peri-operative atrial fibrillationpatients with preoperatively shows in echocardiographic parameters LVEF lower 40%. |
| patients with present preserved left ventricular ejection fraction | – | Diagnostic Test: Detection of peri-operative atrial fibrillationpatients with preoperatively shows in echocardiographic parameters LVEF higher 40%. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- A prospective study was conducted in patients referred to the Cardiac Surgery De-partment from the National Thoracic Institute from Santiago, Chile, between October to December 2021, inclusively. The follow-up includes 2 groups: i) patients with preserved LVEF (pLVEF, n=7) and ii) patients with reduced LVEF (rLVEF, n=5).
Key inclusion criteria (1 listed)
- age ≥18 years, chronic heart failure (WHO-functional class II, III) for at least 3 months before surgery. At the baseline visit, 7-10 days before surgery, the patients were classified by echocardiography as HF with pLVEF (LVEF >40%) or HF with rLVEF (LVEF ≤40%).
Key exclusion criteria (2 listed)
- Patients with history or evidence of AF, previous myocardial infarction, current use of amiodarone, severe congestive heart failure (New York Heart Association class III or IV), presence of prosthetic valves, congenital valvular disease, chronic rheumatic, neoplastic diseases, liver insufficiency, severe chronic kidney disease (serum creatinine >2.5 mg/dl), recent infections ( 2 weeks) and emergency surgery or repair of cyanotic heart disease.
- In addition, patients receiving nonsteroidal anti-inflammatory drugs, corticosteroids, antioxidants, vitamins, or fish oil supplements, three months before surgery were also excluded.
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 |
|---|---|---|
| Detection of peri-operative atrial fibrillationAlso: Detection of oxidative stress markers of protein and lipid peroxidationatrial tissue and plasma from patients with atrial fibrillation detection were analyzed for determine lipid and protein oxidation, and detect markers of myocardial injury. | Diagnostic test | patients with present preserved left ventricular ejection fraction, patients with present reduced left ventricular ejection fraction |
Primary outcome
Postoperative atrial fibrillation
Time frame: cardiac recording monitoring from surgery until the fifth postoperative day
The presence of ECG-documented atrial fibrillation for at least 1 min was considered as a postoperative atrial fibrillation event.
1 secondary outcome
Oxidative stress markers
Time frame: Samples obtained at surgical time and on fourty eight hours from surgery
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Feb 2024.
- Background: PubMed 33516400Noubiap JJ, Sanders P, Nattel S, Lau DH. Biomarkers in Atrial Fibrillation: Pathogenesis and Clinical Implications. Card Electrophysiol Clin. 2021 Mar;13(1):221-233. doi: 10.1016/j.ccep.2020.10.006.
- Results publication: PubMed 33220426Thavendiranathan P, Negishi T, Somerset E, Negishi K, Penicka M, Lemieux J, Aakhus S, Miyazaki S, Shirazi M, Galderisi M, Marwick TH; SUCCOUR Investigators. Strain-Guided Management of Potentially Cardiotoxic Cancer Therapy. J Am Coll Cardiol. 2021 Feb 2;77(4):392-401. doi: 10.1016/j.jacc.2020.11.020. Epub 2020 Nov 18.
- Results publication: PubMed 8660627Benzie IF, Strain JJ. The ferric reducing ability of plasma (FRAP) as a measure of "antioxidant power": the FRAP assay. Anal Biochem. 1996 Jul 15;239(1):70-6. doi: 10.1006/abio.1996.0292.
- Results publication: PubMed 16358993Szymczyk G, Beltowski J, Marciniak A, Kotarski J. Serum isoprostanes levels in patients after abdominal hysterectomy. Rocz Akad Med Bialymst. 2005;50:322-4.
- Results publication: PubMed 32257185Gutierrez-Camacho LR, Kormanovski A, Del Carmen Castillo-Hernandez M, Guevara-Balcazar G, Lara-Padilla E. Alterations in glutathione, nitric oxide and 3-nitrotyrosine levels following exercise and/or hyperbaric oxygen treatment in mice with diet-induced diabetes. Biomed Rep. 2020 May;12(5):222-232. doi: 10.3892/br.2020.1291. Epub 2020 Mar 11.
- Results publication: PubMed 26617218Farias JG, Herrera EA, Carrasco-Pozo C, Sotomayor-Zarate R, Cruz G, Morales P, Castillo RL. Pharmacological models and approaches for pathophysiological conditions associated with hypoxia and oxidative stress. Pharmacol Ther. 2016 Feb;158:1-23. doi: 10.1016/j.pharmthera.2015.11.006. Epub 2015 Nov 23.
- Results publication: PubMed 34306321Xu Y, Guo W, Zeng D, Fang Y, Wang R, Guo D, Qi B, Xue Y, Xue F, Jin Z, Li Y, Zhang M. Inhibiting miR-205 Alleviates Cardiac Ischemia/Reperfusion Injury by Regulating Oxidative Stress, Mitochondrial Function, and Apoptosis. Oxid Med Cell Longev. 2021 Jun 29;2021:9986506. doi: 10.1155/2021/9986506. eCollection 2021.
- Results publication: PubMed 28862654Farias JG, Molina VM, Carrasco RA, Zepeda AB, Figueroa E, Letelier P, Castillo RL. Antioxidant Therapeutic Strategies for Cardiovascular Conditions Associated with Oxidative Stress. Nutrients. 2017 Sep 1;9(9):966. doi: 10.3390/nu9090966.
- Individual participant dataSharing planned: No
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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.
The record lists no contact. Use the official record to reach the sponsor.
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 Atrial Fibrillation and Heart Failure, run by University of Chile at 1 site in Chile.
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 2 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: finished, as of the sponsor's last update on 13 Feb 2024. 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 Chile. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Postoperative atrial fibrillation (time frame: cardiac recording monitoring from surgery until the fifth postoperative day). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06256965, which also lists 8 linked publications.
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 13 Feb 2024; AzTrials last refreshed its copy on 1 Nov 2026.