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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03431844
Recruitment Status : Completed
First Posted : February 13, 2018
Last Update Posted : August 5, 2020
Sponsor:
Collaborators:
Tartu University Hospital
North Estonia Medical Centre
Information provided by (Responsible Party):
Henery Kroon, University of Tartu

Study Description
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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.


Condition or disease
Myocardial Ischemia Coronary Artery Bypass Surgery

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 Design
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Study Type : Observational
Actual Enrollment : 106 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Prospective Clinical Observational Study of Humanin Isoforms in Cardiac Muscle and Blood Plasma and Their Association to Major Complications After Cardiac Operation
Actual Study Start Date : January 1, 2018
Actual Primary Completion Date : August 31, 2019
Actual Study Completion Date : August 31, 2019

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Heart Surgery

Groups and Cohorts
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Outcome Measures
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Primary Outcome Measures :
  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.


Biospecimen Retention:   Samples With DNA
Right atrial heartmuscle biopsy, blood samples.

Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Probability 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.
Criteria

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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03431844


Locations
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Estonia
North Estonia Medical Centre
Tallinn, Harjumaa, Estonia, 13419
Tartu University Hospital
Tartu, Tartumaa, Estonia, 51014
Sponsors and Collaborators
University of Tartu
Tartu University Hospital
North Estonia Medical Centre
Investigators
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Study Director: Joel Starkopf, MD, PhD Tartu University Hospital
More Information
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Responsible Party: Henery Kroon, Researcher, University of Tartu
ClinicalTrials.gov Identifier: NCT03431844    
Other Study ID Numbers: HN1160
First Posted: February 13, 2018    Key Record Dates
Last Update Posted: August 5, 2020
Last Verified: August 2020

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Myocardial Ischemia
Ischemia
Pathologic Processes
 Heart Diseases
Cardiovascular Diseases
Vascular Diseases