Serum Irisin in Myocardial Infraction and Following Percutaneous Coronary Intevention

NCT02498431 | Completed

• 1 other identifier: IRICARDIO
• Study Type: interventional
• Target: 116
• Locations: 1 country
• Sites: 1

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.

Conditions

Myocardial Infarction; Coronary Artery Disease

Keywords

irisin; myocardial infarction; coronary

Outcome Measures

Primary Outcomes (1)

• changes from baseline in serum irisin measured by ELISA

  baseline and 6 hours or 24 hours

Secondary Outcomes (12)

• changes from baseline in troponin

  baseline and 6 hours or 24 hours

• changes from baseline in serum lactate dehydrogenase

  baseline and 6 hours or 24 hours

• changes from baseline in serum creatine kinase

  baseline and 6 hours or 24 hours

• changes from baseline in serum creatine kinase-MB isoenzyme

  baseline and 6 hours or 24 hours

• changes from baseline in serum follistatin

  baseline and 6 hours or 24 hours

Study Arms (3)

myocardial infraction

EXPERIMENTAL

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; Procedure: coronary angiography; Device: Stent, Medronic Resolute Integrity

coronary artery disease

ACTIVE COMPARATOR

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; Procedure: coronary angiography; Device: Stent, Medronic Resolute Integrity

Control

ACTIVE COMPARATOR

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

Procedure: coronary angiography

Interventions

percutaneous coronary intervention PROCEDURE

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

Also known as: coronary angioplasty

coronary artery disease; myocardial infraction

coronary angiography PROCEDURE

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

Control; coronary artery disease; myocardial infraction

Stent, Medronic Resolute Integrity 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; myocardial infraction

Eligibility Criteria

• Age: 30 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients with acute myocardial infraction (MI) or with coronary artery disease without myocardial infraction who need percutaneous coronary intervention

You may not qualify if:

• 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

Sponsors & Collaborators

• 424 General Military Hospital: lead

Study Sites (1)

424 General Military Hospital

Thessaloniki, 56429, Greece

Location

Related Publications (7)

• 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.

  PMID: 22237023 BACKGROUND

• 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.

  PMID: 23219488 BACKGROUND

• 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.

  PMID: 23018146 BACKGROUND

• 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.

  PMID: 24345335 BACKGROUND

• 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.

  PMID: 24576483 BACKGROUND

• 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.

  PMID: 24747283 BACKGROUND

• 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.

  PMID: 24916788 BACKGROUND

MeSH Terms

Conditions

Myocardial Infarction; Coronary Artery Disease

Interventions

Percutaneous Coronary Intervention; Angioplasty, Balloon; Stents

Condition Hierarchy (Ancestors)

Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Vascular Diseases; Infarction; Ischemia; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Necrosis; Coronary Disease; Arteriosclerosis; Arterial Occlusive Diseases

Intervention Hierarchy (Ancestors)

Endovascular Procedures; Vascular Surgical Procedures; Cardiovascular Surgical Procedures; Surgical Procedures, Operative; Minimally Invasive Surgical Procedures; Angioplasty; Catheterization; Therapeutics; Investigative Techniques; Prostheses and Implants; Equipment and Supplies

Study Officials

• Athanasios D Anastasilakis, PhD

  424 General Military Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Consultant of Endocrinology

Study Record Dates

• First Submitted: July 8, 2015
• First Posted: July 15, 2015
• Study Start: June 1, 2015
• Primary Completion: December 1, 2015
• Study Completion: December 1, 2015
• Last Updated: January 18, 2017

Record last verified: 2017-01

Locations

GR (1)