Humanin Isoforms in Cardiac Muscle and Blood Plasma and Major Complications After Cardiac Operation

Completed

• Conditions: Myocardial Ischemia; Coronary Artery Bypass Surgery

• Registration Number: NCT03431844
• Lead Sponsor: University of Tartu

Brief Summary

Objective of the study is to clarify humanin-like peptide concentration in myocard tissue and in blood and to study if its concentration level is related to early complication occurrence and frequency after cardiac operation.

Hypothesis of the study is that previously described elements are related to each other.

Detailed Description

Data collection: Historical medical and preoperative data, operation data (type of operation performed and its details), detailed postoperative course (occurrence of complications).

Specimen collection:

* Tissue sample is taken during the operation from the right atrial appendage of the heart and the sample is frozen at -80 C.

* Blood samples are taken just before the operation, one hour after aortic cross-clamp removal and the next morning after the operation. Samples are processed and blood plasma is frozen at -80 C.

Study Timeline

• Study Start: 2018-01-01
• Study First Submitted: 2018-01-18
• Study First Submitted QC: 2018-02-12
• Study First Posted: 2018-02-13
• Primary Completion: 2019-08-31
• Study Completion: 2019-08-31
• Status Verified: 2020-08
• Last Update Submitted: 2020-08-03
• Last Update Posted: 2020-08-05

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 106

Inclusion Criteria

• Age at least 18 years
• Ischemic heart disease in medical history
• Planned on-pump coronary artery bypass graft (CABG) operation
• Signed informed consent by patient

Exclusion Criteria

• Age <18 years
• Planned isolate valve or aortic operation
• Patient is in another study with an intervention
• Absence of signed informed consent

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Mortality	30 days	30-day all-cause mortality
Major complications: myocardial infarction.	30 days	Diagnosed myocardial infarction.
Major complications: acute kidney injury.	30 days	Diagnosed acute kidney failure (KDIGO stage).
Major complications: stroke.	30 days	Diagnosed stroke.

Trial Locations

Locations (2)

North Estonia Medical Centre; 🇪🇪 Tallinn, Harjumaa, Estonia

Tartu University Hospital; 🇪🇪 Tartu, Tartumaa, Estonia