Transfer of Cardioprotection During RIPC
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|ClinicalTrials.gov Identifier: NCT01956708|
Recruitment Status : Unknown
Verified December 2014 by Prof. Dr. med. Markus Kamler, University Hospital, Essen.
Recruitment status was: Recruiting
First Posted : October 8, 2013
Last Update Posted : December 3, 2014
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 or disease||Intervention/treatment||Phase|
|CABG||Procedure: RIPC||Phase 2 Phase 3|
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.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||332 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Triple (Participant, Investigator, Outcomes Assessor)|
|Primary Purpose:||Basic Science|
|Study Start Date :||September 2013|
|Estimated Primary Completion Date :||September 2015|
|Estimated Study Completion Date :||September 2016|
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
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
- Myocardial protection: cumulative postoperative troponin I release [ Time Frame: 72 h, postoperatively ]
- 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 ]
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): NCT01956708
|Contact: Markus Kamler, MDfirstname.lastname@example.org|
|Contact: Petra Kleinbongard, PhDemail@example.com|
|Herzzentrum Essen - Huttrop gGmbH, Einrichtung des Universitätsklinikums Essen||Recruiting|
|Essen, Germany, 4130|
|Contact: Markus Kamler, MD +49-201-2802211 firstname.lastname@example.org|
|Contact: Petra Kleinbongard, PhD +49-201-723-2763 email@example.com|
|Principal Investigator: Markus Kamler, MD|
|Principal Investigator:||Markus Kamler, MD||Herzzentrum Essen - Huttrop gGmbH, Einrichtung des Universitätsklinikums Essen, Essen, Germany|