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NCT Number: NCT02118025

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

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.

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Key information

Conditions

Coronary Artery Disease Arterial Occlusive Diseases Arteriosclerosis Cardiovascular Diseases Coronary Disease Heart Diseases Myocardial Ischemia Vascular Diseases

Age range

18 year–90 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Hospital de la Santa Creu i Sant Pau

Barcelona, 08026, Spain

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Off-pump coronary artery bypass graft

Procedure

Patients operated with the heart beating, without heart arrest.

Mini extracorporeal circulation bypass

Procedure

Patients operated with a modified extracorporeal circulation system

Primary outcomes

  1. 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.

Secondary outcomes

  1. 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.

  2. 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.

  3. Operative results

    Time frame: Within the first 30 days (plus or minus 3 days) after surgery

    Number of distal anastomosis.

  4. Operative results

    Time frame: Within the first 30 days (plus or minus 3 days) after surgery

    Type of grafts used.

  5. Operative results

    Time frame: Within the first 30 days (plus or minus 3 days) after surgery

    time until removal of mechanical respiratory support

  6. Operative results

    Time frame: Within the first 30 days (plus or minus 3 days) after surgery

    Time at intensive care unit (days)

  7. Operative results

    Time frame: Within the first 30 days (plus or minus 3 days) after surgery

    Total hospitalization time (days)

Sponsors and collaborators

Lead sponsor

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

Other

Registry information

Official study title

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

Important dates

Study start
2006
Primary completion
2008
Study completion
2013
First posted
Apr 21, 2014
Registry last updated
Apr 21, 2014

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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