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

Coronary Artery Disease Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02118025
• Other study ID #: MECC-1
• Secondary ID: MECC-1
• Status: Completed
• Phase: N/A
• First received: March 25, 2014
• Last updated: April 16, 2014
• Start date: January 2006
• Est. completion date: June 2013

Study information

• Verified date: March 2014
• Source: Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau
• Contact: n/a
• Is FDA regulated: No
• Health authority: Spain: Ethics Committee
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 230
• Est. completion date: June 2013
• Est. primary completion date: November 2008
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 90 Years

Eligibility

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 Design

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

• Coronary Artery Disease
• Coronary Disease
• Myocardial Ischemia

Intervention

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

Locations

Country	Name	City	State
Spain	Hospital de la Santa Creu i Sant Pau	Barcelona

Sponsors (1)

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

Country where clinical trial is conducted

Spain, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Clinical outcomes	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	Yes
Secondary	Determination of increase over the first 48 hours of plasma levels of 19 circulating markers of inflammatory response.	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)	Yes
Secondary	Biochemical outcomes	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	Yes
Secondary	Operative results	Number of distal anastomosis.	Within the first 30 days (plus or minus 3 days) after surgery	Yes
Secondary	Operative results	Type of grafts used.	Within the first 30 days (plus or minus 3 days) after surgery	Yes
Secondary	Operative results	time until removal of mechanical respiratory support	Within the first 30 days (plus or minus 3 days) after surgery	Yes
Secondary	Operative results	Time at intensive care unit (days)	Within the first 30 days (plus or minus 3 days) after surgery	Yes
Secondary	Operative results	Total hospitalization time (days)	Within the first 30 days (plus or minus 3 days) after surgery	Yes