Evaluation of a Local Preconditioning Effect in Patients Undergoing Cardiac Surgery

The recruitment status of this study is unknown because the information has not been verified recently.
Verified March 2012 by Medical University of Vienna.
Recruitment status was  Recruiting
Sponsor:
Information provided by (Responsible Party):
Werner Mohl, Medical University of Vienna
ClinicalTrials.gov Identifier:
NCT01482780
First received: November 29, 2011
Last updated: March 5, 2012
Last verified: March 2012
  Purpose

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.


Condition Intervention
Heart Disease
Coronary Artery Bypass Graft Surgery
With or Without Concomitant Valve Surgery
With Antegrade/Retrograde Cold Blood Cardioplegia
Device: PICSO

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Single Blind (Subject)
Primary Purpose: Treatment
Official Title: EASY-TRIAL: Evaluation of a Local Preconditioning Effect in Patients Undergoing Cardiac Surgery

Resource links provided by NLM:


Further study details as provided by Medical University of Vienna:

Primary Outcome Measures:
  • Reduction in enzyme leakage measured by AUC. [ Time Frame: 72 hours postop ] [ Designated as safety issue: No ]

    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


Secondary Outcome Measures:
  • Combined endpoint of major adverse cardiovascular events (MACE) and mortality after 30 days. [ Time Frame: 30 days ] [ Designated as safety issue: No ]
  • 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 ] [ Designated as safety issue: No ]
  • Pre-operative (1d) as well as post-operative (6, 12, 24, 48, 72 h, 30d) C-reactive protein (CRP) measurements [ Time Frame: 30 days ] [ Designated as safety issue: No ]

Estimated Enrollment: 90
Study Start Date: March 2012
Estimated Study Completion Date: March 2014
Estimated Primary Completion Date: March 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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 Name: PICSO, Miracor medical Systems, Austria
No Intervention: Control

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.
  Eligibility

Ages Eligible for Study:   18 Years to 85 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01482780

Contacts
Contact: Werner Mohl, DDr. 0043 1 40400 6989 werner.mohl@meduniwien.ac.at
Contact: Martin Andreaa, MD martin.andreas@meduniwien.ac.at

Locations
Austria
Medical University of Vienna Recruiting
Vienna, Austria, A-1090
Contact: Werner Mohl, DDr.    0043 1 40400 6989    werner.mohl@meduniwien.ac.at   
Principal Investigator: Werner Mohl, DDr.         
Sponsors and Collaborators
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
  More Information

No publications provided

Responsible Party: Werner Mohl, Clinical Professor, Medical University of Vienna
ClinicalTrials.gov Identifier: NCT01482780     History of Changes
Other Study ID Numbers: EASY-TRIAL
Study First Received: November 29, 2011
Last Updated: March 5, 2012
Health Authority: Austria: Agency for Health and Food Safety

Additional relevant MeSH terms:
Heart Diseases
Cardiovascular Diseases

ClinicalTrials.gov processed this record on August 28, 2014