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

Myocardial Ischemia Clinical Trial

Official title:

Prospective Clinical Observational Study of Humanin Isoforms in Cardiac Muscle and Blood Plasma and Their Association to Major Complications After Cardiac Operation

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03431844
• Other study ID #: HN1160
• Status: Completed
• Start date: January 1, 2018
• Est. completion date: August 31, 2019

Study information

• Verified date: August 2020
• Source: University of Tartu
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 106
• Est. completion date: August 31, 2019
• Est. primary completion date: August 31, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Coronary Artery Bypass Surgery
• Ischemia
• Myocardial Ischemia

Locations

Country	Name	City	State
Estonia	North Estonia Medical Centre	Tallinn	Harjumaa
Estonia	Tartu University Hospital	Tartu	Tartumaa

Sponsors (3)

Lead Sponsor	Collaborator
University of Tartu	North Estonia Medical Centre, Tartu University Hospital

Country where clinical trial is conducted

Estonia, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Mortality	30-day all-cause mortality	30 days
Primary	Major complications: myocardial infarction.	Diagnosed myocardial infarction.	30 days
Primary	Major complications: acute kidney injury.	Diagnosed acute kidney failure (KDIGO stage).	30 days
Primary	Major complications: stroke.	Diagnosed stroke.	30 days