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OpenTrials
Completed

NCT Number: NCT06256965

Cardiopulmonary Bypass and Ventricular Remodeling

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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Faculty of Medicine, University of Chile

Santiago, 7500922, Chile

About this study

  • 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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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%).

Exclusion criteria

  • 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.

Treatment and study plan

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.

Other names: Detection of oxidative stress markers of protein and lipid peroxidation

Primary outcomes

  1. 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.

Secondary outcomes

  1. Oxidative stress markers

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

    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

Sponsors and collaborators

Lead sponsor

University of Chile

Other

Collaborators

  • Hospital del Salvador

Registry information

Official study title

Left Ventricular Ejection Fraction and Oxidative Stress Markers in Patients Subjected to Car-diac Surgery With Cardiopulmonary Bypass

Acronym: CBP-VR

Important dates

Study start
2021
Primary completion
2021
Study completion
2022
First posted
Feb 13, 2024
Registry last updated
Feb 13, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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