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

Primary Purpose

Myocardial Infarction, Coronary Artery Disease

Status
Completed
Phase
Not Applicable
Locations
Greece
Study Type
Interventional
Intervention
percutaneous coronary intervention
coronary angiography
Stent, Medronic Resolute Integrity
Sponsored by
424 General Military Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Myocardial Infarction focused on measuring irisin, myocardial infarction, coronary

Eligibility Criteria

30 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • 424 General Military Hospital

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Active Comparator

Active Comparator

Arm Label

myocardial infraction

coronary artery disease

Control

Arm Description

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

Patients with coronary artery disease but not myocardial infraction who are being subjected to coronary angiography and percutaneous coronary intervention and stent placement

Patients subjected to coronary angiography and found with no presence of coronary artery disease

Outcomes

Primary Outcome Measures

changes from baseline in serum irisin measured by ELISA

Secondary Outcome Measures

changes from baseline in troponin
changes from baseline in serum lactate dehydrogenase
changes from baseline in serum creatine kinase
changes from baseline in serum creatine kinase-MB isoenzyme
changes from baseline in serum follistatin
changes from baseline in serum follistatin-like protein 3 (FSTL-3)
changes from baseline in serum Activin A
changes from baseline in serum Activin B
changes from baseline in serum insulin growth factor 1 (IGF1)
changes from baseline in serum insulin growth factor binding protein 3 (IGFBP3)
changes from baseline in serum insulin growth factor binding protein 4 (IGFBP4)
changes from baseline in serum pico pregnancy-associated plasma protein A (PAPP-A)

Full Information

First Posted
July 8, 2015
Last Updated
January 14, 2017
Sponsor
424 General Military Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT02498431
Brief Title
Serum Irisin in Myocardial Infraction and Following Percutaneous Coronary Intevention
Acronym
IRICARDIO
Official Title
Serum Irisin Levels in Myocardial Infraction and Following Percutaneous Coronary Intevention
Study Type
Interventional

2. Study Status

Record Verification Date
January 2017
Overall Recruitment Status
Completed
Study Start Date
June 2015 (undefined)
Primary Completion Date
December 2015 (Actual)
Study Completion Date
December 2015 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
424 General Military Hospital

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.
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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Myocardial Infarction, Coronary Artery Disease
Keywords
irisin, myocardial infarction, coronary

7. Study Design

Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
116 (Actual)

8. Arms, Groups, and Interventions

Arm Title
myocardial infraction
Arm Type
Experimental
Arm Description
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
Arm Title
coronary artery disease
Arm Type
Active Comparator
Arm Description
Patients with coronary artery disease but not myocardial infraction who are being subjected to coronary angiography and percutaneous coronary intervention and stent placement
Arm Title
Control
Arm Type
Active Comparator
Arm Description
Patients subjected to coronary angiography and found with no presence of coronary artery disease
Intervention Type
Procedure
Intervention Name(s)
percutaneous coronary intervention
Other Intervention Name(s)
coronary angioplasty
Intervention Description
a non-surgical procedure used to treat the stenotic (narrowed) coronary arteries of the heart found in coronary heart disease
Intervention Type
Procedure
Intervention Name(s)
coronary angiography
Intervention Description
is a procedure performed along with cardiac catheterization that uses X-ray imaging to see your heart's blood vessels
Intervention Type
Device
Intervention Name(s)
Stent, Medronic Resolute Integrity
Intervention Description
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.
Primary Outcome Measure Information:
Title
changes from baseline in serum irisin measured by ELISA
Time Frame
baseline and 6 hours or 24 hours
Secondary Outcome Measure Information:
Title
changes from baseline in troponin
Time Frame
baseline and 6 hours or 24 hours
Title
changes from baseline in serum lactate dehydrogenase
Time Frame
baseline and 6 hours or 24 hours
Title
changes from baseline in serum creatine kinase
Time Frame
baseline and 6 hours or 24 hours
Title
changes from baseline in serum creatine kinase-MB isoenzyme
Time Frame
baseline and 6 hours or 24 hours
Title
changes from baseline in serum follistatin
Time Frame
baseline and 6 hours or 24 hours
Title
changes from baseline in serum follistatin-like protein 3 (FSTL-3)
Time Frame
baseline and 6 hours or 24 hours
Title
changes from baseline in serum Activin A
Time Frame
baseline and 6 hours or 24 hours
Title
changes from baseline in serum Activin B
Time Frame
baseline and 6 hours or 24 hours
Title
changes from baseline in serum insulin growth factor 1 (IGF1)
Time Frame
baseline and 6 hours or 24 hours
Title
changes from baseline in serum insulin growth factor binding protein 3 (IGFBP3)
Time Frame
baseline and 6 hours or 24 hours
Title
changes from baseline in serum insulin growth factor binding protein 4 (IGFBP4)
Time Frame
baseline and 6 hours or 24 hours
Title
changes from baseline in serum pico pregnancy-associated plasma protein A (PAPP-A)
Time Frame
baseline and 6 hours or 24 hours

10. Eligibility

Sex
All
Minimum Age & Unit of Time
30 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Athanasios D Anastasilakis, PhD
Organizational Affiliation
424 General Military Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
424 General Military Hospital
City
Thessaloniki
ZIP/Postal Code
56429
Country
Greece

12. IPD Sharing Statement

Citations:
PubMed Identifier
22237023
Citation
Bostrom P, Wu J, Jedrychowski MP, Korde A, Ye L, Lo JC, Rasbach KA, Bostrom EA, Choi JH, Long JZ, Kajimura S, Zingaretti MC, Vind BF, Tu H, Cinti S, Hojlund K, Gygi SP, Spiegelman BM. A PGC1-alpha-dependent myokine that drives brown-fat-like development of white fat and thermogenesis. Nature. 2012 Jan 11;481(7382):463-8. doi: 10.1038/nature10777.
Results Reference
background
PubMed Identifier
23219488
Citation
Stengel A, Hofmann T, Goebel-Stengel M, Elbelt U, Kobelt P, Klapp BF. Circulating levels of irisin in patients with anorexia nervosa and different stages of obesity--correlation with body mass index. Peptides. 2013 Jan;39:125-30. doi: 10.1016/j.peptides.2012.11.014. Epub 2012 Dec 3.
Results Reference
background
PubMed Identifier
23018146
Citation
Huh JY, Panagiotou G, Mougios V, Brinkoetter M, Vamvini MT, Schneider BE, Mantzoros CS. FNDC5 and irisin in humans: I. Predictors of circulating concentrations in serum and plasma and II. mRNA expression and circulating concentrations in response to weight loss and exercise. Metabolism. 2012 Dec;61(12):1725-38. doi: 10.1016/j.metabol.2012.09.002. Epub 2012 Sep 25.
Results Reference
background
PubMed Identifier
24345335
Citation
Aydin S, Kuloglu T, Aydin S, Eren MN, Celik A, Yilmaz M, Kalayci M, Sahin I, Gungor O, Gurel A, Ogeturk M, Dabak O. Cardiac, skeletal muscle and serum irisin responses to with or without water exercise in young and old male rats: cardiac muscle produces more irisin than skeletal muscle. Peptides. 2014 Feb;52:68-73. doi: 10.1016/j.peptides.2013.11.024. Epub 2013 Dec 15.
Results Reference
background
PubMed Identifier
24576483
Citation
Kuloglu T, Aydin S, Eren MN, Yilmaz M, Sahin I, Kalayci M, Sarman E, Kaya N, Yilmaz OF, Turk A, Aydin Y, Yalcin MH, Uras N, Gurel A, Ilhan S, Gul E, Aydin S. Irisin: a potentially candidate marker for myocardial infarction. Peptides. 2014 May;55:85-91. doi: 10.1016/j.peptides.2014.02.008. Epub 2014 Feb 24.
Results Reference
background
PubMed Identifier
24747283
Citation
Aydin S, Aydin S, Kobat MA, Kalayci M, Eren MN, Yilmaz M, Kuloglu T, Gul E, Secen O, Alatas OD, Baydas A. Decreased saliva/serum irisin concentrations in the acute myocardial infarction promising for being a new candidate biomarker for diagnosis of this pathology. Peptides. 2014 Jun;56:141-5. doi: 10.1016/j.peptides.2014.04.002. Epub 2014 Apr 18.
Results Reference
background
PubMed Identifier
24916788
Citation
Aronis KN, Moreno M, Polyzos SA, Moreno-Navarrete JM, Ricart W, Delgado E, de la Hera J, Sahin-Efe A, Chamberland JP, Berman R, Spiro A 3rd, Vokonas P, Fernandez-Real JM, Mantzoros CS. Circulating irisin levels and coronary heart disease: association with future acute coronary syndrome and major adverse cardiovascular events. Int J Obes (Lond). 2015 Jan;39(1):156-61. doi: 10.1038/ijo.2014.101. Epub 2013 Jun 11.
Results Reference
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Serum Irisin in Myocardial Infraction and Following Percutaneous Coronary Intevention

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