Cardiopulmonary Bypass and Ventricular Remodeling (CBP-VR)

February 5, 2024 updated by: RODRIGO CASTILLO, University of Chile

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed 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.

Study Type

Observational

Enrollment (Actual)

12

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Chile
      • Santiago, Chile, 7500922
        • Faculty of Medicine, University of Chile

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

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).

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
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
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
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
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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
cardiac recording monitoring from surgery until the fifth postoperative day

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
Samples obtained at surgical time and on fourty eight hours from surgery

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Chile

Collaborators

Hospital del Salvador

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

October 4, 2021

Primary Completion (Actual)

November 15, 2021

Study Completion (Actual)

June 13, 2022

Study Registration Dates

First Submitted

February 5, 2024

First Submitted That Met QC Criteria

February 5, 2024

First Posted (Estimated)

February 13, 2024

Study Record Updates

Last Update Posted (Estimated)

February 13, 2024

Last Update Submitted That Met QC Criteria

February 5, 2024

Last Verified

February 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CBA180619

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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