NCT03431844

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
106

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Jan 2018

Geographic Reach
1 country

2 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2018

Completed
17 days until next milestone

First Submitted

Initial submission to the registry

January 18, 2018

Completed
26 days until next milestone

First Posted

Study publicly available on registry

February 13, 2018

Completed
1.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 31, 2019

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 31, 2019

Completed
Last Updated

August 5, 2020

Status Verified

August 1, 2020

Enrollment Period

1.7 years

First QC Date

January 18, 2018

Last Update Submit

August 3, 2020

Conditions

Myocardial IschemiaCoronary Artery Bypass Surgery

Outcome Measures

Primary Outcomes (4)

  • Mortality

    30-day all-cause mortality

    30 days

  • Major complications: myocardial infarction.

    Diagnosed myocardial infarction.

    30 days

  • Major complications: acute kidney injury.

    Diagnosed acute kidney failure (KDIGO stage).

    30 days

  • Major complications: stroke.

    Diagnosed stroke.

    30 days

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

All adult patients who have a history of ischemic heart disease and who are going to have an elective on-pump CABG operation.

You may qualify if:

  • 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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

North Estonia Medical Centre

Tallinn, Harju, 13419, Estonia

Location

Tartu University Hospital

Tartu, Tartu, 51014, Estonia

Location

Biospecimen

Retention: SAMPLES WITH DNA

Right atrial heartmuscle biopsy, blood samples.

MeSH Terms

Conditions

Myocardial Ischemia

Condition Hierarchy (Ancestors)

Heart DiseasesCardiovascular DiseasesVascular Diseases

Study Officials

  • Joel Starkopf, MD, PhD

    Tartu University Hospital

    STUDY DIRECTOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Researcher

Study Record Dates

First Submitted

January 18, 2018

First Posted

February 13, 2018

Study Start

January 1, 2018

Primary Completion

August 31, 2019

Study Completion

August 31, 2019

Last Updated

August 5, 2020

Record last verified: 2020-08

Locations

ES(2)