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
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|Condition or disease||Intervention/treatment||Phase|
|Heart Disease Coronary Artery Bypass Graft Triple Vessel||Device: PICSO||Not Applicable|
- 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 (Clinical Trial)|
|Actual Enrollment :||5 participants|
|Intervention Model:||Single Group Assignment|
|Official Title:||EASY-TRIAL: Evaluation of a Local Preconditioning Effect in Patients Undergoing Cardiac Surgery|
|Study Start Date :||March 2012|
|Actual Primary Completion Date :||March 2014|
|Actual Study Completion Date :||March 2014|
PICSO (pressure controlled intermittent coronary sinus occlusion), a special coronary sinus catheter will be introduced after induction of anaesthesia until going on bypass.
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
normal procedure of preparing Bypass grafts. Equivalent time before going on Bypass is determined as control period
- 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).
- PICSO reduces troponin T leakage about 30 % measured by AUC until 72h in comparison to controls.
- PICSO improves 30d and long-term outcome
- 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 ]
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|Ages Eligible for Study:||18 Years to 85 Years (Adult, Older Adult)|
|Sexes Eligible for Study:||All|
|Accepts Healthy Volunteers:||No|
- 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.
- 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
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01482780
|Medical University of Vienna|
|Vienna, Austria, A-1090|
|Principal Investigator:||Werner Mohl, DDr||Medical University of Vienna, Abteilung für Herz-, Thoraxchirurgie|
|Study Director:||Werner Mohl, DDr.||Medical University of Vienna|
|Responsible Party:||Werner Mohl, Clinical Professor, Medical University of Vienna|
|Other Study ID Numbers:||
|First Posted:||December 1, 2011 Key Record Dates|
|Last Update Posted:||April 7, 2015|
|Last Verified:||April 2015|