Serum Irisin in Myocardial Infraction and Following Percutaneous Coronary Intevention (IRICARDIO)

January 14, 2017 updated by: Athanasios D. Anastasilakis, 424 General Military Hospital

Serum Irisin Levels in Myocardial Infraction and Following Percutaneous Coronary Intevention

The investigators aim to evaluate circulating irisin levels alterations in patients with acute myocardial infraction and in patients with coronary artery disease subjected to percutaneous coronary intervention.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Irisin is a newly discovered myokine induced in exercise. There is evidence that cardiac muscle produces more irisin than skeletal muscle in response to exercise. Furthermore, irisin has been associated with isoproterenol-induced myocardial infarction (MI) in rats while it has been reported to decrease after acute myocardial infarction in humans.

The investigators aim 1) to investigate circulating irisin levels in patients at the time of acute myocardial infarction and after reprefusion [primary percutaneous coronary intervention (PCI)] 2) to compare irisin' s diagnostic and prognostic value and specificity value in myocardial infarction with known markers of cardiac injury such as creatine kinase-MB isoenzyme (CK-MB) and troponin 3) to evaluate irisin as an early necrosis biomarker 4) To evaluate irisin's sensitivity as a biomarker to detect minor myocardial necrosis after elective percutaneous coronary intervention

Study Type

Interventional

Enrollment (Actual)

116

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Greece
      • Thessaloniki, Greece, 56429
        • 424 General Military Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

30 years to 80 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Patients with acute myocardial infraction (MI) or with coronary artery disease without myocardial infraction who need percutaneous coronary intervention

Exclusion Criteria:

  • age < 20 years old
  • diseases or medications that could affect cardiac muscle or skeletal muscle metabolism
  • musculoskeletal injury of surgery 6 months prior to recruitment
  • severe liver or kidney disease (creatinine clearance < 60ml/min/1.73m2) or liver or kidney transplantation

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Diagnostic
  • Allocation: Non-Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: myocardial infraction
Patients with acute myocardial infraction who are admitted to the emergency department of 424 General Military Hospital before and after percutaneous coronary intervention and stent placement
Procedure: percutaneous coronary intervention
a non-surgical procedure used to treat the stenotic (narrowed) coronary arteries of the heart found in coronary heart disease
Other Names:
  • coronary angioplasty
Procedure: coronary angiography
is a procedure performed along with cardiac catheterization that uses X-ray imaging to see your heart's blood vessels
Device: Stent, Medronic Resolute Integrity
A stent is placed in an artery as part of a procedure called percutaneous coronary intervention (PCI) to restore blood flow through narrow or blocked arteries. A stent helps support the inner wall of the artery in the months or years after PCI.
Active Comparator: coronary artery disease
Patients with coronary artery disease but not myocardial infraction who are being subjected to coronary angiography and percutaneous coronary intervention and stent placement
Procedure: percutaneous coronary intervention
a non-surgical procedure used to treat the stenotic (narrowed) coronary arteries of the heart found in coronary heart disease
Other Names:
  • coronary angioplasty
Procedure: coronary angiography
is a procedure performed along with cardiac catheterization that uses X-ray imaging to see your heart's blood vessels
Device: Stent, Medronic Resolute Integrity
A stent is placed in an artery as part of a procedure called percutaneous coronary intervention (PCI) to restore blood flow through narrow or blocked arteries. A stent helps support the inner wall of the artery in the months or years after PCI.
Active Comparator: Control
Patients subjected to coronary angiography and found with no presence of coronary artery disease
Procedure: coronary angiography
is a procedure performed along with cardiac catheterization that uses X-ray imaging to see your heart's blood vessels

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
changes from baseline in serum irisin measured by ELISA
Time Frame: baseline and 6 hours or 24 hours
baseline and 6 hours or 24 hours

Secondary Outcome Measures

Outcome Measure
Time Frame
changes from baseline in troponin
Time Frame: baseline and 6 hours or 24 hours
baseline and 6 hours or 24 hours
changes from baseline in serum lactate dehydrogenase
Time Frame: baseline and 6 hours or 24 hours
baseline and 6 hours or 24 hours
changes from baseline in serum creatine kinase
Time Frame: baseline and 6 hours or 24 hours
baseline and 6 hours or 24 hours
changes from baseline in serum creatine kinase-MB isoenzyme
Time Frame: baseline and 6 hours or 24 hours
baseline and 6 hours or 24 hours
changes from baseline in serum follistatin
Time Frame: baseline and 6 hours or 24 hours
baseline and 6 hours or 24 hours
changes from baseline in serum follistatin-like protein 3 (FSTL-3)
Time Frame: baseline and 6 hours or 24 hours
baseline and 6 hours or 24 hours
changes from baseline in serum Activin A
Time Frame: baseline and 6 hours or 24 hours
baseline and 6 hours or 24 hours
changes from baseline in serum Activin B
Time Frame: baseline and 6 hours or 24 hours
baseline and 6 hours or 24 hours
changes from baseline in serum insulin growth factor 1 (IGF1)
Time Frame: baseline and 6 hours or 24 hours
baseline and 6 hours or 24 hours
changes from baseline in serum insulin growth factor binding protein 3 (IGFBP3)
Time Frame: baseline and 6 hours or 24 hours
baseline and 6 hours or 24 hours
changes from baseline in serum insulin growth factor binding protein 4 (IGFBP4)
Time Frame: baseline and 6 hours or 24 hours
baseline and 6 hours or 24 hours
changes from baseline in serum pico pregnancy-associated plasma protein A (PAPP-A)
Time Frame: baseline and 6 hours or 24 hours
baseline and 6 hours or 24 hours

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

424 General Military Hospital

Investigators

  • Principal Investigator: Athanasios D Anastasilakis, PhD, 424 General Military Hospital

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

June 1, 2015

Primary Completion (Actual)

December 1, 2015

Study Completion (Actual)

December 1, 2015

Study Registration Dates

First Submitted

July 8, 2015

First Submitted That Met QC Criteria

July 14, 2015

First Posted (Estimate)

July 15, 2015

Study Record Updates

Last Update Posted (Estimate)

January 18, 2017

Last Update Submitted That Met QC Criteria

January 14, 2017

Last Verified

January 1, 2017

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • IRICARDIO

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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