Skip to main content
OpenTrials
Completed

NCT Number: NCT03431844

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

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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Myocardial Ischemia Cardiovascular Diseases Coronary Artery Bypass Surgery Heart Diseases Vascular Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

North Estonia Medical Centre, Tallinn, Harju, Estonia

Loading trial locations.

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

  1. Mortality

    Time frame: 30 days

    30-day all-cause mortality

  2. Major complications: myocardial infarction.

    Time frame: 30 days

    Diagnosed myocardial infarction.

  3. Major complications: acute kidney injury.

    Time frame: 30 days

    Diagnosed acute kidney failure (KDIGO stage).

  4. Major complications: stroke.

    Time frame: 30 days

    Diagnosed stroke.

Sponsors and collaborators

Lead sponsor

University of Tartu

Other

Collaborators

  • North Estonia Medical Centre
  • Tartu University Hospital

Registry information

Official study title

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

Important dates

Study start
2018
Primary completion
2019
Study completion
2019
First posted
Feb 13, 2018
Registry last updated
Aug 5, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.