Cardiopulmonary Bypass and Ventricular Remodeling — CBP-VR  

Heart Failure Clinical Trial

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

Status Completed

Clinical 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. 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.

Clinical Trial Description

1. 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.

2. 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.

3. 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 %.

4. 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. ;

Related Conditions & MeSH terms

• Atrial Fibrillation
• Heart Failure

• NCT number: NCT06256965
• Study type: Observational [Patient Registry]
• Source: University of Chile
• Status: Completed
• Start date: October 4, 2021
• Completion date: June 13, 2022