Transfer of Cardioprotection During RIPC

CABG Clinical Trial

Official title:

Transfer of Cardioprotection During Remote Ischemic Conditioning

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01956708
• Other study ID #: RIPC-13-5507-BO
• Status: Completed
• Phase: N/A
• Start date: September 2013
• Est. completion date: April 20, 2020

Study information

• Verified date: October 2021
• Source: University Hospital, Essen
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

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.

Recruitment information / eligibility

• 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

Related Conditions & MeSH terms

• CABG

Intervention

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

Locations

Country	Name	City	State
Germany	Herzzentrum Essen - Huttrop gGmbH, Einrichtung des Universitätsklinikums Essen	Essen

Sponsors (1)

Lead Sponsor	Collaborator
University Hospital, Essen

Country where clinical trial is conducted

Germany, 

Outcome

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