Remote Ischemic Preconditioning in Coronary Artery Bypass Grafting With Cold Crystalloid Cardioplegic Arrest

Myocardial Injury Clinical Trial

Official title:

Effect of Remote Ischemic Preconditioning in Patients Undergoing On-pump Coronary Artery Bypass Graft Surgery With Crystalloid Cardioplegic Arrest

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01406678
• Other study ID #: WDHZ-TC-0801
• Status: Completed
• Phase: Phase 2/Phase 3
• Start date: July 2008
• Est. completion date: April 2020

Study information

• Verified date: May 2023
• 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 reduces myocardial injury in patients undergoing on-pump coronary artery bypass (CABG) surgery with cross-clamp fibrillation or blood cardioplegia for myocardial protection. The present study assesses protection of heart, brain and kidney by RIPC under crystalloid cardioplegic arrest. The study also addresses safety and clinical outcome.

Description:

Remote ischemic preconditioning (RIPC) protocol after induction of anesthesia and before skin incision consists of 3 cycles of 5 minutes left upper arm ischemia by inflation of a blood pressure cuff to 200 mmHg and 5 minutes of reperfusion. For myocardial molecular analyses, left ventricular biopsies are taken before induction of cardioplegic cardiac arrest and at 10 minutes after aortic unclamping during reperfusion of the myocardium.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 1204
• Est. completion date: April 2020
• Est. primary completion date: March 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Consecutive patients >18 years of age
• Double- or triple-vessel coronary artery disease
• Elective isolated first-time CABG
• Combined valve surgery + CABG
• Written informed consent

Exclusion Criteria:

• Renal failure (creatinine = 200 µmol/L)
• Peripheral vascular disease affecting upper limbs
• Preoperative inotropic support
• Any kind of mechanical assist device
• Acute or recent (<4 weeks) acute coronary syndromes
• Any PCI (<6 weeks)
• Any reasons for preoperative cTnI elevation
• Emergency surgery
• Redo surgery

Related Conditions & MeSH terms

• Ischemia
• Myocardial Injury

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
• Control
Coronary artery bypass surgery without remote ischemic preconditioning protocol

Drug:
• isoflurane+sufentanil anesthesia
Anaesthesia is maintained by inhaled isoflurane in concentrations 0.7-0.8 % end-tidal with additional sufentanil injected during surgery, as required. During extracorporal circulation patients receive isoflurane via a vaporizer incorporated in the extracorporeal gas supply in the same concentrations.

Locations

Country	Name	City	State
Germany	Department of Thoracic and Cardiovascular Surgery, West-German Heart Center, University Duisburg-Essen	Essen

Sponsors (1)

Lead Sponsor	Collaborator
University Hospital, Essen

Country where clinical trial is conducted

Germany, 

References & Publications (1)

Thielmann M, Kottenberg E, Boengler K, Raffelsieper C, Neuhaeuser M, Peters J, Jakob H, Heusch G. Remote ischemic preconditioning reduces myocardial injury after coronary artery bypass surgery with crystalloid cardioplegic arrest. Basic Res Cardiol. 2010 — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Perioperative extent of myocardial injury as measured by cardiac troponin I serum release over 72 hours after CABG surgery and its area under the curve (AUC).		72 hours postoperatively after CABG surgery
Secondary	All-cause mortality		30 days and 1 year and complete follow-up after CABG surgery
Secondary	Major adverse cardiac and cerebrovascular events (MACCE)		at 30 days and 1 year and complete follow-up after CABG surgery
Secondary	Myocardial infarction		30 days and 1 year and complete follow-up after CABG surgery
Secondary	Renal function		72 hours post CABG