Evaluation of a Local Preconditioning Effect in Patients Undergoing Cardiac Surgery

EASY-TRIAL: Evaluation of a Local Preconditioning Effect in Patients Undergoing Cardiac Surgery

The aim of the study is to analyze the potential of pressure controlled intermittent coronary sinus occlusion (PICSO) to prevent/reverse the ischemic burden as well as reperfusion injury. To achieve insight into the clinical significance of this local preconditioning effect, global hemodynamics, cardiac performance and clinical outcome in the first 30 days will be related to the ability of this intervention to protect the myocardium in elective surgical procedures, ameliorating cellular decay and preserving the microcirculation therefore improving graft flow, reducing enzyme leakage and finally improving myocardial performance.

Study Overview

• Status: Terminated
• Conditions: Heart Disease; Coronary Artery Bypass Graft Triple Vessel
• Intervention / Treatment: Device: PICSO

Detailed Description

• Patients undergoing elective coronary artery bypass graft (CABG) will be enrolled in this study.
• A computerized randomization process is used to obtain similar distributions within each group. Stratification will be done by the severity of coronary artery disease, age and sex.
• Routine blood sampling will be performed the day before surgery as well as a transthoracic echocardiography (TTE) study to determine ventricular volumes and valvular function.
• A modified Minnesota quality of Life questionnaire will be assessed and these data will be compared with 30 days outcome data screened in an outpatient environment.
• A 12 lead electrocardiogram will be obtained. To assess eligibility and to assure grouping (stratification & randomization) patients will be scored using the additive EuroSCORE. Pre-, intra-, and postoperative (up to 72 hrs) measurements of myocardial enzyme leakage will be performed using standard diagnostic procedures (cardiac troponin T, CK-MB, and total creatine kinase), as well as serial electrocardiograms and echocardiograms.
• Perioperative infarction will be assessed as the development of new persistent regional wall motion abnormalities in echocardiography together with electrocardiographic alterations and CK-MB increases and new Q-wave PMI.
• Sequential cytokine analyses (IL-1, IL-6, IL-8, IL-10, IL-17, VEGF and TNF- alpha ) preoperatively, at the beginning of the operation, the beginning of ECC and 6,24 h and 30 days postop.
• Serial quantification of global and regional wall motion will be recorded using TEE measurements during surgery.

• Study Type: Interventional
• Enrollment (Actual): 5
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Austria
  • Vienna, Austria, A-1090
    • Medical University of Vienna

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 85 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• Adult patients of either sex and between 18 and 85 years of age scheduled for surgery without severe confounding disease will be asked to participate in the study.
• Written informed consent will be obtained in eligible patients.

Exclusion Criteria:

• Patients with unstable angina pectoris and/or myocardial infarction within the last 30 days, as well as persons with planned concomitant valvular interventions will be excluded. Patients with malignoma, severe hepatic, renal and pulmonary disease will also be excluded

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Single Group Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: PICSO; PICSO (pressure controlled intermittent coronary sinus occlusion), a special coronary sinus catheter will be introduced after induction of anaesthesia until going on bypass.	Device: PICSO; PICSO (pressure controlled intermittent coronary sinus occlusion) will be used in the pre ECC period. The procedure of PICSO will be performed in analogy to retrograde cardioplegia.; Other Names: PICSO, Miracor medical Systems, Austria
No Intervention: Control; normal procedure of preparing Bypass grafts. Equivalent time before going on Bypass is determined as control period

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Reduction in enzyme leakage measured by AUC.	Enzyme leakage (Troponin T, CK-MB) will be measured preoperatively, at the beginning of the operation, the beginning of ECC at the time of reperfusion the arrival on the ICU and 6,12,24,48 and 72 hours postop and the area under the curve will be calculated (AUC until 72 hours). Study Hypotheses: PICSO reduces troponin T leakage about 30 % measured by AUC until 72h in comparison to controls.; PICSO improves 30d and long-term outcome	72 hours postop

Secondary Outcome Measures

Outcome Measure	Time Frame
Combined endpoint of major adverse cardiovascular events (MACE) and mortality after 30 days.	30 days
N-terminales pro brain natriuretic peptide (NT-pro BNP) values at 1 day pre-surgery as well as 30d and 6 months post-operative	30 days
Pre-operative (1d) as well as post-operative (6, 12, 24, 48, 72 h, 30d) C-reactive protein (CRP) measurements	30 days

Collaborators and Investigators

• Sponsor: Medical University of Vienna
• Investigators: Principal Investigator: Werner Mohl, DDr, Medical University of Vienna, Abteilung für Herz-, Thoraxchirurgie; Study Director: Werner Mohl, DDr., Medical University of Vienna

Study record dates

Study Major Dates

• Study Start: March 1, 2012
• Primary Completion (Actual): March 1, 2014
• Study Completion (Actual): March 1, 2014

Study Registration Dates

• First Submitted: November 29, 2011
• First Submitted That Met QC Criteria: November 29, 2011
• First Posted (Estimate): December 1, 2011

Study Record Updates

• Last Update Posted (Estimate): April 7, 2015
• Last Update Submitted That Met QC Criteria: April 6, 2015
• Last Verified: April 1, 2015

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Cardiovascular Diseases; Heart Diseases
• Other Study ID Numbers: EASY-TRIAL