Serum Irisin in Myocardial Infraction and Following Percutaneous Coronary Intevention

Coronary Artery Disease Clinical Trial

— IRICARDIO  

Official title:

Serum Irisin Levels in Myocardial Infraction and Following Percutaneous Coronary Intevention

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02498431
• Other study ID #: IRICARDIO
• Status: Completed
• Phase: N/A
• First received: July 8, 2015
• Last updated: January 14, 2017
• Start date: June 2015
• Est. completion date: December 2015

Study information

• Verified date: January 2017
• Source: 424 General Military Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 116
• Est. completion date: December 2015
• Est. primary completion date: December 2015
• Accepts healthy volunteers: No
• Gender: All
• Age group: 30 Years to 80 Years

Eligibility

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

Related Conditions & MeSH terms

• Coronary Artery Disease
• Coronary Disease
• Infarction
• Myocardial Infarction
• Myocardial Ischemia

Intervention

Procedure:
• percutaneous coronary intervention
a non-surgical procedure used to treat the stenotic (narrowed) coronary arteries of the heart found in coronary heart disease
• 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.

Locations

Country	Name	City	State
Greece	424 General Military Hospital	Thessaloniki

Sponsors (1)

Lead Sponsor	Collaborator
424 General Military Hospital

Country where clinical trial is conducted

Greece, 

References & Publications (7)

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, Fernández-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. — View 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. — View 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. — View Citation

Boström P, Wu J, Jedrychowski MP, Korde A, Ye L, Lo JC, Rasbach KA, Boström EA, Choi JH, Long JZ, Kajimura S, Zingaretti MC, Vind BF, Tu H, Cinti S, Højlund K, Gygi SP, Spiegelman BM. A PGC1-a-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. — View 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. — View 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. — View 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	changes from baseline in serum irisin measured by ELISA		baseline and 6 hours or 24 hours
Secondary	changes from baseline in troponin		baseline and 6 hours or 24 hours
Secondary	changes from baseline in serum lactate dehydrogenase		baseline and 6 hours or 24 hours
Secondary	changes from baseline in serum creatine kinase		baseline and 6 hours or 24 hours
Secondary	changes from baseline in serum creatine kinase-MB isoenzyme		baseline and 6 hours or 24 hours
Secondary	changes from baseline in serum follistatin		baseline and 6 hours or 24 hours
Secondary	changes from baseline in serum follistatin-like protein 3 (FSTL-3)		baseline and 6 hours or 24 hours
Secondary	changes from baseline in serum Activin A		baseline and 6 hours or 24 hours
Secondary	changes from baseline in serum Activin B		baseline and 6 hours or 24 hours
Secondary	changes from baseline in serum insulin growth factor 1 (IGF1)		baseline and 6 hours or 24 hours
Secondary	changes from baseline in serum insulin growth factor binding protein 3 (IGFBP3)		baseline and 6 hours or 24 hours
Secondary	changes from baseline in serum insulin growth factor binding protein 4 (IGFBP4)		baseline and 6 hours or 24 hours
Secondary	changes from baseline in serum pico pregnancy-associated plasma protein A (PAPP-A)		baseline and 6 hours or 24 hours