Serum Irisin in Myocardial Infraction and Following Percutaneous Coronary Intevention

NCT ID: NCT02498431

Last Updated: 2017-01-18

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

116 participants

Study Classification

INTERVENTIONAL

Study Start Date

2015-06-30

Study Completion Date

2015-12-31

Brief Summary

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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

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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

Conditions

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Myocardial Infarction Coronary Artery Disease

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

DIAGNOSTIC

Blinding Strategy

NONE

Study Groups

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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

Group Type EXPERIMENTAL

percutaneous coronary intervention

Intervention Type PROCEDURE

a non-surgical procedure used to treat the stenotic (narrowed) coronary arteries of the heart found in coronary heart disease

coronary angiography

Intervention Type PROCEDURE

is a procedure performed along with cardiac catheterization that uses X-ray imaging to see your heart's blood vessels

Stent, Medronic Resolute Integrity

Intervention Type DEVICE

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.

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

Group Type ACTIVE_COMPARATOR

percutaneous coronary intervention

Intervention Type PROCEDURE

a non-surgical procedure used to treat the stenotic (narrowed) coronary arteries of the heart found in coronary heart disease

coronary angiography

Intervention Type PROCEDURE

is a procedure performed along with cardiac catheterization that uses X-ray imaging to see your heart's blood vessels

Stent, Medronic Resolute Integrity

Intervention Type DEVICE

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.

Control

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

Group Type ACTIVE_COMPARATOR

coronary angiography

Intervention Type PROCEDURE

is a procedure performed along with cardiac catheterization that uses X-ray imaging to see your heart's blood vessels

Interventions

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percutaneous coronary intervention

a non-surgical procedure used to treat the stenotic (narrowed) coronary arteries of the heart found in coronary heart disease

Intervention Type PROCEDURE

coronary angiography

is a procedure performed along with cardiac catheterization that uses X-ray imaging to see your heart's blood vessels

Intervention Type PROCEDURE

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.

Intervention Type DEVICE

Other Intervention Names

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coronary angioplasty

Eligibility Criteria

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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
Minimum Eligible Age

30 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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424 General Military Hospital

OTHER

Sponsor Role lead

Responsible Party

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Athanasios D. Anastasilakis

Consultant of Endocrinology

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Athanasios D Anastasilakis, PhD

Role: PRINCIPAL_INVESTIGATOR

424 General Military Hospital

Locations

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424 General Military Hospital

Thessaloniki, , Greece

Site Status

Countries

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Greece

References

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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.

Reference Type BACKGROUND
PMID: 22237023 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 23219488 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 23018146 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 24345335 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 24576483 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 24747283 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 24916788 (View on PubMed)

Other Identifiers

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IRICARDIO

Identifier Type: -

Identifier Source: org_study_id

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