Clinical trial NCT02498431: Serum Irisin in Myocardial Infraction and Following Percutaneous Coronary Intevention
Official title: Serum Irisin Levels in Myocardial Infraction and Following Percutaneous Coronary Intevention
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Myocardial Infarction
Coronary Artery Disease
Keywords: irisin
myocardial infarction
coronary
Lead sponsor: 424 General Military Hospital
Sponsor class: OTHER
First posted: 2015-07-15
Enrollment: 116
Sex: ALL
Minimum age (years): 30
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: DIAGNOSTIC

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

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

Primary outcomes:
measure: changes from baseline in serum irisin measured by ELISA
timeFrame: baseline and 6 hours or 24 hours
Secondary outcomes:
measure: changes from baseline in troponin
timeFrame: baseline and 6 hours or 24 hours
measure: changes from baseline in serum lactate dehydrogenase
timeFrame: baseline and 6 hours or 24 hours
measure: changes from baseline in serum creatine kinase
timeFrame: baseline and 6 hours or 24 hours
measure: changes from baseline in serum creatine kinase-MB isoenzyme
timeFrame: baseline and 6 hours or 24 hours
measure: changes from baseline in serum follistatin
timeFrame: baseline and 6 hours or 24 hours
measure: changes from baseline in serum follistatin-like protein 3 (FSTL-3)
timeFrame: baseline and 6 hours or 24 hours
measure: changes from baseline in serum Activin A
timeFrame: baseline and 6 hours or 24 hours
measure: changes from baseline in serum Activin B
timeFrame: baseline and 6 hours or 24 hours
measure: changes from baseline in serum insulin growth factor 1 (IGF1)
timeFrame: baseline and 6 hours or 24 hours
measure: changes from baseline in serum insulin growth factor binding protein 3 (IGFBP3)
timeFrame: baseline and 6 hours or 24 hours
measure: changes from baseline in serum insulin growth factor binding protein 4 (IGFBP4)
timeFrame: baseline and 6 hours or 24 hours
measure: changes from baseline in serum pico pregnancy-associated plasma protein A (PAPP-A)
timeFrame: baseline and 6 hours or 24 hours
Other outcomes:
Locations:
city: Thessaloniki
country: Greece
facility: 424 General Military Hospital
Study officials:
affiliation: 424 General Military Hospital
name: Athanasios D Anastasilakis, PhD
role: PRINCIPAL_INVESTIGATOR
References:
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.
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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.
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.
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.
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.
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.