CABG Clinical Trial
Official title:
Transfer of Cardioprotection During Remote Ischemic Conditioning
Verified date | October 2021 |
Source | University Hospital, Essen |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
Status | Completed |
Enrollment | 392 |
Est. completion date | April 20, 2020 |
Est. primary completion date | April 20, 2020 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility | 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 |
Country | Name | City | State |
---|---|---|---|
Germany | Herzzentrum Essen - Huttrop gGmbH, Einrichtung des Universitätsklinikums Essen | Essen |
Lead Sponsor | Collaborator |
---|---|
University Hospital, Essen |
Germany,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Myocardial protection | Cumulative postoperative troponin T release | 72 h, postoperatively | |
Secondary | All-cause mortality | follow up done by studynurses | 30 days and 1 year after CABG surgery and after complete follow-up | |
Secondary | MACCE | Major adverse cardiac and cerebrovascular events | 30 days and 1 year after CABG surgery after complete follow-up | |
Secondary | renal function | Creatinine and eGFR | 72 h, postoperatively | |
Secondary | Cardioprotective factors released into circulating blood | Analysis of blood plasma | before skin incision versus 1-72 h after RIPC | |
Secondary | Myocardial function in vitro | left ventricular pressure (lvp) and maximum left ventricular pressure (lvdp) in an isolated perfused rodent heart after blood plasma infusion | after RIPC |
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