Cardiopulmonary Bypass and Ventricular Remodeling

NCT06256965 | Completed

• 1 other identifier: CBA180619
• Study Type: observational
• Target: 12
• Locations: 1 country
• Sites: 1

Brief 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\. 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.

Conditions

Atrial Fibrillation; Heart Failure

Keywords

left ventricular ejection fraction; oxidative stress; cardiopulmonary bypass; atrial tissue

Outcome Measures

Primary Outcomes (1)

• Postoperative atrial fibrillation

  The presence of ECG-documented atrial fibrillation for at least 1 min was considered as a postoperative atrial fibrillation event.

  cardiac recording monitoring from surgery until the fifth postoperative day

Secondary Outcomes (1)

• Oxidative stress markers

  Samples obtained at surgical time and on fourty eight hours from surgery

Study Arms (2)

patients with present reduced left ventricular ejection fraction

patients with preoperatively shows in echocardiographic parameters LVEF lower 40%.

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%.

Diagnostic Test: Detection of peri-operative atrial fibrillation

Interventions

Detection of peri-operative atrial fibrillation DIAGNOSTIC_TEST

atrial tissue and plasma from patients with atrial fibrillation detection were analyzed for determine lipid and protein oxidation, and detect markers of myocardial injury.

Also known as: Detection of oxidative stress markers of protein and lipid peroxidation

patients with present preserved left ventricular ejection fraction; patients with present reduced left ventricular ejection fraction

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

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).

You may qualify if:

• 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%).

You may not qualify if:

• 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.

Sponsors & Collaborators

• University of Chile: lead
• Hospital del Salvador: collaborator

Study Sites (1)

Faculty of Medicine, University of Chile

Santiago, 7500922, Chile

Location

Related Publications (8)

• 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.

  PMID: 33516400 BACKGROUND

• Thavendiranathan 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.

  PMID: 33220426 RESULT

• Benzie 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.

  PMID: 8660627 RESULT

• Szymczyk G, Beltowski J, Marciniak A, Kotarski J. Serum isoprostanes levels in patients after abdominal hysterectomy. Rocz Akad Med Bialymst. 2005;50:322-4.

  PMID: 16358993 RESULT

• Gutierrez-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.

  PMID: 32257185 RESULT

• Farias 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.

  PMID: 26617218 RESULT

• Xu 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.

  PMID: 34306321 RESULT

• Farias 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.

  PMID: 28862654 RESULT

Biospecimen

Retention: SAMPLES WITHOUT DNA

1\. Tissue from right atrial appendage were obtained at surgical time after sternotomy and froozen at -80 Celsius degrees. Whoole blood samples obtained at surgical time after sternotomy were centrifuged at 3000 × g for 10 min. Plasma samples from each patient were stored at -80°C until performing the biochemical determinations of oxidative stress status.

MeSH Terms

Conditions

Atrial Fibrillation; Heart Failure

Interventions

Lipid Peroxidation

Condition Hierarchy (Ancestors)

Arrhythmias, Cardiac; Heart Diseases; Cardiovascular Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Biochemical Phenomena; Chemical Phenomena; Oxidation-Reduction; Energy Metabolism; Metabolism

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: CROSS SECTIONAL
• Target Duration: 9 Months
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Rodrigouch

Study Record Dates

• First Submitted: February 5, 2024
• First Posted: February 13, 2024
• Study Start: October 4, 2021
• Primary Completion: November 15, 2021
• Study Completion: June 13, 2022
• Last Updated: February 13, 2024

Record last verified: 2024-02

Data Sharing

• IPD Sharing: Will not share

Locations

CL (1)