Coronary Bypass Grafting With Minimal Extracorporeal Circulation System Versus Off-pump Coronary Surgery

April 16, 2014 updated by: Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau

Prospective Randomized Comparison of Coronary Bypass Grafting With Minimal Extracorporeal Circulation System (MECC) Versus Off-pump Coronary Surgery. New Insights Into Inflammatory Cytokines.

The investigators aimed to evaluate the clinical results and the inflammatory response of the minimal extracorporeal circulation system (MECC) Compared with off-pump coronary revascularization (OPCABG).

This is a randomized and prospective study in 230 patients with indications for coronary surgery, with 113 patients in the OPCABG group and 117 in the MECC group. The endpoints were the clinical and biochemical results, intra-operative outcomes and the determination of 19 inflammatory circulating markers, 17 of them for the first time analyzed comparing both techniques.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Actual)

230

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

  • Spain
      • Barcelona, Spain, 08026
        • Hospital De La Santa Creu I Sant Pau

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

18 years to 90 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Probability Sample

Study Population

230 patients with indication for coronary surgery established on the basis of current published guidelines. All patients provided written consent to enter the study.

Description

Inclusion Criteria:

  • Indication for coronary surgery established on the basis of current published guidelines

Exclusion Criteria:

  • Documented preoperative systemic proinflammatory status and/or steroid administration within 6 months before surgery.
  • Coexistence of a cardiomyopathy different than coronary artery disease that precise surgical treatment.
  • Left ventricle ejection fraction of 40% or less.
  • Treatment with erythropoietin (EPO) three months before the intervention
  • Hematocrit less than 35% the day prior to the procedure
  • Redo surgery

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
Off-pump coronary artery bypass graft
Patients operated on with off-pump coronary artery bypass graft, beating heart surgery.
Procedure: Off-pump coronary artery bypass graft
Patients operated with the heart beating, without heart arrest.
Mini extracorporeal circulation bypass
Patients operated on with mini extracorporeal circulation bypass. A modified extracorporeal system.
Procedure: Mini extracorporeal circulation bypass
Patients operated with a modified extracorporeal circulation system

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Clinical outcomes
Time Frame: within the first 30 days (plus or minus 3 days) after surgery
Number of Participants with Adverse Events, e.g, renal failure, atrial fibrillation, acute myocardial infarct, stroke, redo surgery, death.
within the first 30 days (plus or minus 3 days) after surgery

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Determination of increase over the first 48 hours of plasma levels of 19 circulating markers of inflammatory response.
Time Frame: Area Under the Concentration-Time Curve (AUC 0-48 hours)
Determination of increase over the first 48 hours after the operation of plasma levels of 19 circulating markers of inflammatory response. The levels of inflammatory markers are measured in pg / mL and subsequently, the increase over the 48 hours is determined with the area under the curve.
Area Under the Concentration-Time Curve (AUC 0-48 hours)
Biochemical outcomes
Time Frame: Within the first 30 days (plus or minus 3 days) after surgery
Changes in creatine kinase levels, troponin levels, glucose, leukocytes, platelets, hemoglobin and hematocrit levels. From basal point to 48 hours time after surgery.
Within the first 30 days (plus or minus 3 days) after surgery
Operative results
Time Frame: Within the first 30 days (plus or minus 3 days) after surgery
Number of distal anastomosis.
Within the first 30 days (plus or minus 3 days) after surgery
Operative results
Time Frame: Within the first 30 days (plus or minus 3 days) after surgery
Type of grafts used.
Within the first 30 days (plus or minus 3 days) after surgery
Operative results
Time Frame: Within the first 30 days (plus or minus 3 days) after surgery
time until removal of mechanical respiratory support
Within the first 30 days (plus or minus 3 days) after surgery
Operative results
Time Frame: Within the first 30 days (plus or minus 3 days) after surgery
Time at intensive care unit (days)
Within the first 30 days (plus or minus 3 days) after surgery
Operative results
Time Frame: Within the first 30 days (plus or minus 3 days) after surgery
Total hospitalization time (days)
Within the first 30 days (plus or minus 3 days) after surgery

Collaborators and Investigators

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

Sponsor

Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau

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

January 1, 2006

Primary Completion (Actual)

November 1, 2008

Study Completion (Actual)

June 1, 2013

Study Registration Dates

First Submitted

March 25, 2014

First Submitted That Met QC Criteria

April 16, 2014

First Posted (Estimate)

April 21, 2014

Study Record Updates

Last Update Posted (Estimate)

April 21, 2014

Last Update Submitted That Met QC Criteria

April 16, 2014

Last Verified

March 1, 2014

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • MECC-1 (Other Identifier: MECC-1)

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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