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Transfer of Cardioprotection During RIPC

NCT ID: NCT01956708

Last Updated: 2021-10-18

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

392 participants

Study Classification

INTERVENTIONAL

Study Start Date

2013-09-30

Study Completion Date

2020-04-20

Brief Summary

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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.

Detailed Description

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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.

Conditions

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CABG

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

BASIC_SCIENCE

Blinding Strategy

TRIPLE

Participants Investigators Outcome Assessors

Study Groups

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Remote ischemic preconditioning

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

Group Type ACTIVE_COMPARATOR

RIPC

Intervention Type PROCEDURE

3 cycles of 5 min left upper arm ischemia by inflation of a blood pressure cuff to 200 mmHg and 5 min reperfusion

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

Group Type PLACEBO_COMPARATOR

RIPC

Intervention Type PROCEDURE

3 cycles of 5 min left upper arm ischemia by inflation of a blood pressure cuff to 200 mmHg and 5 min reperfusion

Interventions

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RIPC

3 cycles of 5 min left upper arm ischemia by inflation of a blood pressure cuff to 200 mmHg and 5 min reperfusion

Intervention Type PROCEDURE

Other Intervention Names

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RIPC: Remote ischemic preconditioning

Eligibility Criteria

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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 T 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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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University Hospital, Essen

OTHER

Sponsor Role lead

Responsible Party

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Prof. Dr. med. Markus Kamler

Prof. Dr. med. Markus Kamler

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Markus Kamler, MD

Role: PRINCIPAL_INVESTIGATOR

Herzzentrum Essen - Huttrop gGmbH, Einrichtung des Universitätsklinikums Essen, Essen, Germany

Locations

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Herzzentrum Essen - Huttrop gGmbH, Einrichtung des Universitätsklinikums Essen

Essen, , Germany

Site Status

Countries

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Germany

Other Identifiers

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RIPC-13-5507-BO

Identifier Type: -

Identifier Source: org_study_id