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Completed

NCT Number: NCT01956708

Transfer of Cardioprotection During RIPC

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.

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Key information

Conditions

CABG

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Herzzentrum Essen - Huttrop gGmbH, Einrichtung des Universitätsklinikums Essen

Essen, 4130, Germany

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

RIPC

Procedure

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

Other names: RIPC: Remote ischemic preconditioning

Primary outcomes

  1. Myocardial protection

    Time frame: 72 h, postoperatively

    Cumulative postoperative troponin T release

Secondary outcomes

  1. All-cause mortality

    Time frame: 30 days and 1 year after CABG surgery and after complete follow-up

    follow up done by studynurses

  2. MACCE

    Time frame: 30 days and 1 year after CABG surgery after complete follow-up

    Major adverse cardiac and cerebrovascular events

  3. renal function

    Time frame: 72 h, postoperatively

    Creatinine and eGFR

  4. Cardioprotective factors released into circulating blood

    Time frame: before skin incision versus 1-72 h after RIPC

    Analysis of blood plasma

  5. Myocardial function in vitro

    Time frame: after RIPC

    left ventricular pressure (lvp) and maximum left ventricular pressure (lvdp) in an isolated perfused rodent heart after blood plasma infusion

Sponsors and collaborators

Lead sponsor

University Hospital, Essen

Other

Registry information

Official study title

Transfer of Cardioprotection During Remote Ischemic Conditioning

Important dates

Study start
2013
Primary completion
2020
Study completion
2020
First posted
Oct 8, 2013
Registry last updated
Oct 18, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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