Analysis of extracellular vesicles and circulating microRNAs in remote ischemic preconditioning of coronary artery disease patients dependent on anesthetic regime

Phase 3

• Conditions: I25.1; Atherosclerotic heart disease

• Registration Number: DRKS00015682
• Lead Sponsor: Ruhr-Universität Bochum Marienhospital HerneKlinik für Anästhesiologie, operative Intensivmedizin,Schmerz- und Palliativmedizin

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2018-12-20
• Study Completion: 2020-08-01
• Last Update Posted: 19 August 2024

Recruitment & Eligibility

• Status: Complete
• Sex: All
• Target Recruitment: 65

Inclusion Criteria

Coronary heart disease
• CABG (Coronary artery bypass graft) surgery with cardiopulmonary bypass
• ages 45 to 85 years
• Antegrade Bretschneider cardioplegia
• Mild hypothermia (32C °)
• Preoperative standard medication (statins, beta-blockers, aspirin)
• Standard anesthesia (isoflurane, sufentanil)
• Intraoperative standard protocol (full heparinization with ACT> 400s, aprotinin, protamine)
• Postoperative standard protocol (500mg aspirin after 2 hours, Low-dose heparinization after 4h)

Exclusion Criteria

Condition after acute myocardial infarction
• combined valvular
• Emergency operation
• catecholamine
• Unstable angina
• IABP mounting
• pre- / intraoperative use of phosphodiesterase inhibitors
• reoperation
• COPD GOLD III and IV
• renal insufficiency with creatinine> 1.5 mg / dl
• Dual antithrombotic therapy (clopidogrel + aspirin)

Repeated cardiopulmonary bypass
• Repeated cross clamping of the aorta
• Intraoperative complications (bypass low-flow / -lock, frustrane valve reconstruction, Klappenausriss, aortic dissection, pump failure, implantation of cardiac assist systems)
• aortic cross clamping> 150 min
• Moderate / deep hypothermia (<32C °)
• Antithrombotic therapy (intraoperatively clopidogrel u. / O. Aspirin)
• Retrograde cardioplegia delivery

Study & Design

• Study Type: interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Change of exosomal signature one hour after intervention

Secondary Outcome Measures

Name	Time	Method
maximal postoperative troponin I increase within 7 days after coronary artery bypass surgery postoperatively