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Transfer of Cardioprotection During RIPC

The recruitment status of this study is unknown. The completion date has passed and the status has not been verified in more than two years.
Verified December 2014 by University Hospital, Essen.
Recruitment status was:  Recruiting
Sponsor:
Information provided by (Responsible Party):
Prof. Dr. med. Markus Kamler, University Hospital, Essen
ClinicalTrials.gov Identifier:
NCT01956708
First received: September 27, 2013
Last updated: December 2, 2014
Last verified: December 2014
  Purpose

Remote ischemic preconditioning (RIPC) with transient upper limb ischemia/reperfusion provides peri-operative myocardial protection, is safe and improves prognosis in patients undergoing elective CABG surgery.

The signal transfer from limb to heart is unknown. Thus, the aim of this study is to identify the pathways which transfer the cardioprotective signal from the ischemic/reperfused extremity to the heart in humans undergoing surgical coronary revascularization.


Condition Intervention Phase
CABG
Procedure: RIPC
Phase 2
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator, Outcomes Assessor)
Primary Purpose: Basic Science

Further study details as provided by University Hospital, Essen:

Primary Outcome Measures:
  • Myocardial protection: cumulative postoperative troponin I release [ Time Frame: 72 h, postoperatively ]

Secondary Outcome Measures:
  • All-cause mortality [ Time Frame: 30 days and 1 year after CABG surgery and after complete follow-up ]
  • Major adverse cardiac and cerebrovascular events (MACCE) [ Time Frame: 30 days and 1 year after CABG surgery after complete follow-up ]
  • renal function (creatinine and eGFR) [ Time Frame: 72 h, postoperatively ]
  • Cardioprotective factors released into circulating blood [ Time Frame: before skin incision versus 1-72 h after RIPC ]
  • Myocardial function in vitro [ Time Frame: after RIPC ]

Estimated Enrollment: 332
Study Start Date: September 2013
Estimated Study Completion Date: September 2016
Estimated Primary Completion Date: September 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: RIPC

Remote ischemic preconditioning (RIPC) protocol before coronary artery bypass surgery (CABG):

after induction of anesthesia and before surgery: 3 cycles of 5 minutes left upper arm ischemia by inflation of a blood pressure cuff to 200mmHg and 5 minutes of reperfusion Anesthesia is with isoflurane (0.7-0.8% end-tidal) +sufentanil

Procedure: RIPC
3 cycles of 5 min left upper arm ischemia by inflation of a blood pressure cuff to 200 mmHg and 5 min reperfusion
Other Name: RIPC: Remote ischemic preconditioning
Placebo Comparator: Placebo

No Remote ischemic preconditioning (RIPC) protocol before coronary artery bypass surgery (CABG):

after induction of anesthesia and before surgery: the cuff is left uninflated


Detailed Description:

The investigators will obtain arterial blood samples before skin incision and 1-72 h after the remote ischemic preconditioning protocol and analyze them biochemically. The investigators focus on those ligands that have been previously implicated in conditioning protocols at any organ. In addition, the investigators will use a bioassay system, consisting of a Langendorff-perfused isolated heart with coronary occlusion/reperfusion and infarct size by TTC staining as endpoint, and then expose this bioassay system to arterial plasma obtained after the remote ischemic preconditioning stimulus or placebo. This approach will allow us to further characterize any potential transfer signal candidate with a pharmacological antagonist approach.

The investigators will also obtain human atrial appendages after the remote ischemic preconditioning protocol or placebo and before patients were connected to the extracorporeal circulation. Contractile function of isolated trabeculae and vasomotor function of isolated arterial vessels will be analyzed in a bioassay system.

  Eligibility

Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Consecutive patients > 18 years after written informed consent
  • elective, isolated CABG surgery with and without valvuloplastic surgery
  • two-stage cannulation, cardiopulmonary bypass
  • antegrade Bretschneider cardioplegia
  • mild hypothermia (32°C)
  • preoperative standard medication (statins, betablocker, aspirin)
  • standard anesthesia (see above)
  • intraoperative standard protocol (full heparinization with ACT, aprotinin, protamin)
  • postoperative standard protocol (500 mg aspirin after 2 h, low-dose heparin after 4 h)

Exclusion Criteria:

preoperative

  • prior percutaneous coronary intervention (PCI) within 6 weeks
  • any preoperative troponin I elevation
  • renal insufficiency (creatinine >200 µmol/l)
  • reoperation
  • emergency surgery
  • acute coronary syndrome (unstable angina, STEMI, NSTEMI) within 4 weeks
  • dual anti-platelet therapy (clopidogrel+aspirin)

intraoperative

  • harvesting of a. radialis
  • coronary thrombendarterectomy
  • complications (bypass-low flow/ -occlusion)
  • antithrombotic therapy (intraoperative clopidogrel + aspirin)
  • retrograde cardioplegia
  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: NCT01956708

Contacts
Contact: Markus Kamler, MD +49-201-2802211 markus.kamler@uk-essen.de
Contact: Petra Kleinbongard, PhD +49-201-723-2763 petra.kleinbongard@uk-essen.de

Locations
Germany
Herzzentrum Essen - Huttrop gGmbH, Einrichtung des Universitätsklinikums Essen Recruiting
Essen, Germany, 4130
Contact: Markus Kamler, MD    +49-201-2802211    markus.kamler@heh.uk-essen.de   
Contact: Petra Kleinbongard, PhD    +49-201-723-2763    petra.kleinbongard@uk-essen.de   
Principal Investigator: Markus Kamler, MD         
Sponsors and Collaborators
University Hospital, Essen
Investigators
Principal Investigator: Markus Kamler, MD Herzzentrum Essen - Huttrop gGmbH, Einrichtung des Universitätsklinikums Essen, Essen, Germany
  More Information

Responsible Party: Prof. Dr. med. Markus Kamler, University Hospital, Essen
ClinicalTrials.gov Identifier: NCT01956708     History of Changes
Other Study ID Numbers: RIPC-13-5507-BO
Study First Received: September 27, 2013
Last Updated: December 2, 2014

ClinicalTrials.gov processed this record on March 30, 2017