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

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ClinicalTrials.gov Identifier: NCT02498431
Recruitment Status : Completed
First Posted : July 15, 2015
Last Update Posted : January 18, 2017
Sponsor:
Information provided by (Responsible Party):
Athanasios D. Anastasilakis, 424 General Military Hospital

Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Myocardial Infarction Coronary Artery Disease Procedure: percutaneous coronary intervention Procedure: coronary angiography Device: Stent, Medronic Resolute Integrity Not Applicable

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


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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 116 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
Official Title: Serum Irisin Levels in Myocardial Infraction and Following Percutaneous Coronary Intevention
Study Start Date : June 2015
Actual Primary Completion Date : December 2015
Actual Study Completion Date : December 2015

Resource links provided by the National Library of Medicine


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 Name: 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 Name: 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




Primary Outcome Measures :
  1. changes from baseline in serum irisin measured by ELISA [ Time Frame: baseline and 6 hours or 24 hours ]

Secondary Outcome Measures :
  1. changes from baseline in troponin [ Time Frame: baseline and 6 hours or 24 hours ]
  2. changes from baseline in serum lactate dehydrogenase [ Time Frame: baseline and 6 hours or 24 hours ]
  3. changes from baseline in serum creatine kinase [ Time Frame: baseline and 6 hours or 24 hours ]
  4. changes from baseline in serum creatine kinase-MB isoenzyme [ Time Frame: baseline and 6 hours or 24 hours ]
  5. changes from baseline in serum follistatin [ Time Frame: baseline and 6 hours or 24 hours ]
  6. changes from baseline in serum follistatin-like protein 3 (FSTL-3) [ Time Frame: baseline and 6 hours or 24 hours ]
  7. changes from baseline in serum Activin A [ Time Frame: baseline and 6 hours or 24 hours ]
  8. changes from baseline in serum Activin B [ Time Frame: baseline and 6 hours or 24 hours ]
  9. changes from baseline in serum insulin growth factor 1 (IGF1) [ Time Frame: baseline and 6 hours or 24 hours ]
  10. changes from baseline in serum insulin growth factor binding protein 3 (IGFBP3) [ Time Frame: baseline and 6 hours or 24 hours ]
  11. changes from baseline in serum insulin growth factor binding protein 4 (IGFBP4) [ Time Frame: baseline and 6 hours or 24 hours ]
  12. changes from baseline in serum pico pregnancy-associated plasma protein A (PAPP-A) [ Time Frame: baseline and 6 hours or 24 hours ]


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Ages Eligible for Study:   30 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

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): NCT02498431


Locations
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Greece
424 General Military Hospital
Thessaloniki, Greece, 56429
Sponsors and Collaborators
424 General Military Hospital
Investigators
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Principal Investigator: Athanasios D Anastasilakis, PhD 424 General Military Hospital

Publications:

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Responsible Party: Athanasios D. Anastasilakis, Consultant of Endocrinology, 424 General Military Hospital
ClinicalTrials.gov Identifier: NCT02498431     History of Changes
Other Study ID Numbers: IRICARDIO
First Posted: July 15, 2015    Key Record Dates
Last Update Posted: January 18, 2017
Last Verified: January 2017

Keywords provided by Athanasios D. Anastasilakis, 424 General Military Hospital:
irisin
myocardial infarction
coronary

Additional relevant MeSH terms:
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Infarction
Coronary Artery Disease
Myocardial Ischemia
Coronary Disease
Myocardial Infarction
Ischemia
Pathologic Processes
Necrosis
Heart Diseases
Cardiovascular Diseases
Arteriosclerosis
Arterial Occlusive Diseases
Vascular Diseases