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

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

Status

Completed

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT02118025

Enrollment

230

Registered

2014-04-21

Start date

2006-01-31

Completion date

2013-06-30

Last updated

2014-04-21

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Coronary Artery Disease

Keywords

Off-pump bypass graft surgery, Mini extracorporeal circulation bypass surgery

Brief summary

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.

Interventions

PROCEDUREOff-pump coronary artery bypass graft

Patients operated with the heart beating, without heart arrest.

PROCEDUREMini extracorporeal circulation bypass

Patients operated with a modified extracorporeal circulation system

Study design

Observational model

COHORT

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

18 Years to 90 Years

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame	Description
Clinical outcomes	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.

Secondary

Measure	Time frame	Description
Determination of increase over the first 48 hours of plasma levels of 19 circulating markers of inflammatory response.	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.
Biochemical outcomes	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.
Operative results	Within the first 30 days (plus or minus 3 days) after surgery	Number of distal anastomosis.

Countries

Spain

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 20, 2026