Evaluation of a Local Preconditioning Effect in Patients Undergoing Cardiac Surgery

NCT01482780 | Terminated

• 1 other identifier: EASY-TRIAL
• Study Type: interventional
• Target: 5
• Locations: 1 country
• Sites: 1

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.

Conditions

Heart Disease; Coronary Artery Bypass Graft Triple Vessel

Outcome Measures

Primary Outcomes (1)

• 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: 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

  72 hours postop

Secondary Outcomes (3)

• 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

Study Arms (2)

PICSO

EXPERIMENTAL

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

Control

NO INTERVENTION

normal procedure of preparing Bypass grafts. Equivalent time before going on Bypass is determined as control period

Interventions

PICSO DEVICE

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.

Also known as: PICSO, Miracor medical Systems, Austria

PICSO

Eligibility Criteria

• Age: 18 Years - 85 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Medical University of Vienna: lead

Study Sites (1)

Medical University of Vienna

Vienna, Vienna, A-1090, Austria

Location

MeSH Terms

Conditions

Heart Diseases

Condition Hierarchy (Ancestors)

Cardiovascular Diseases

Study Officials

• Werner Mohl, DDr

  Medical University of Vienna, Abteilung für Herz-, Thoraxchirurgie

  PRINCIPAL INVESTIGATOR

• Werner Mohl, DDr.

  Medical University of Vienna

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Clinical Professor

Study Record Dates

• First Submitted: November 29, 2011
• First Posted: December 1, 2011
• Study Start: March 1, 2012
• Primary Completion: March 1, 2014
• Study Completion: March 1, 2014
• Last Updated: April 7, 2015

Record last verified: 2015-04

Locations

AU (1)