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Evaluation of a Local Preconditioning Effect in Patients Undergoing Cardiac Surgery

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ClinicalTrials.gov Identifier: NCT01482780
Recruitment Status : Terminated (Logistic reasons, lack of funding)
First Posted : December 1, 2011
Last Update Posted : April 7, 2015
Sponsor:
Information provided by (Responsible Party):
Werner Mohl, Medical University of Vienna

Tracking Information
First Submitted Date  ICMJE November 29, 2011
First Posted Date  ICMJE December 1, 2011
Last Update Posted Date April 7, 2015
Study Start Date  ICMJE March 2012
Actual Primary Completion Date March 2014   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: December 1, 2011)
Reduction in enzyme leakage measured by AUC. [ Time Frame: 72 hours postop ]
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:
  1. PICSO reduces troponin T leakage about 30 % measured by AUC until 72h in comparison to controls.
  2. PICSO improves 30d and long-term outcome
Original Primary Outcome Measures  ICMJE
 (submitted: November 29, 2011)
Reduction in troponin T leakage measured by AUC. [ Time Frame: 72 hours postop ]
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: December 1, 2011)
  • Combined endpoint of major adverse cardiovascular events (MACE) and mortality after 30 days. [ Time Frame: 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 [ Time Frame: 30 days ]
  • Pre-operative (1d) as well as post-operative (6, 12, 24, 48, 72 h, 30d) C-reactive protein (CRP) measurements [ Time Frame: 30 days ]
Original Secondary Outcome Measures  ICMJE
 (submitted: November 29, 2011)
Combined endpoint of MACE and mortality after 30 days. [ Time Frame: 30 days ]
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Evaluation of a Local Preconditioning Effect in Patients Undergoing Cardiac Surgery
Official Title  ICMJE EASY-TRIAL: Evaluation of a Local Preconditioning Effect in Patients Undergoing Cardiac Surgery
Brief Summary 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.
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  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: Single (Participant)
Primary Purpose: Treatment
Condition  ICMJE
  • Heart Disease
  • Coronary Artery Bypass Graft Triple Vessel
Intervention  ICMJE 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 Name: PICSO, Miracor medical Systems, Austria
Study Arms  ICMJE
  • 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.
    Intervention: Device: PICSO
  • No Intervention: Control
    normal procedure of preparing Bypass grafts. Equivalent time before going on Bypass is determined as control period
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Terminated
Actual Enrollment  ICMJE
 (submitted: April 6, 2015)
5
Original Estimated Enrollment  ICMJE
 (submitted: November 29, 2011)
90
Actual Study Completion Date  ICMJE March 2014
Actual Primary Completion Date March 2014   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 85 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Austria
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01482780
Other Study ID Numbers  ICMJE EASY-TRIAL
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Werner Mohl, Medical University of Vienna
Study Sponsor  ICMJE Medical University of Vienna
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Werner Mohl, DDr Medical University of Vienna, Abteilung für Herz-, Thoraxchirurgie
Study Director: Werner Mohl, DDr. Medical University of Vienna
PRS Account Medical University of Vienna
Verification Date April 2015

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP