Serum Irisin in Myocardial Infraction and Following Percutaneous Coronary Intevention

Not Applicable

Completed

• Conditions: Myocardial Infarction; Coronary Artery Disease
• Interventions: Procedure: percutaneous coronary intervention; Procedure: coronary angiography; Device: Stent, Medronic Resolute Integrity

• Registration Number: NCT02498431
• Lead Sponsor: 424 General Military Hospital

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

Study Timeline

• Study Start: 2015-06
• Study First Submitted: 2015-07-08
• Study First Submitted QC: 2015-07-14
• Study First Posted: 2015-07-15
• Primary Completion: 2015-12
• Study Completion: 2015-12
• Status Verified: 2017-01
• Last Update Submitted: 2017-01-14
• Last Update Posted: 2017-01-18

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 116

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
myocardial infraction	coronary angiography	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
coronary artery disease	coronary angiography	Patients with coronary artery disease but not myocardial infraction who are being subjected to coronary angiography and percutaneous coronary intervention and stent placement
myocardial infraction	percutaneous coronary intervention	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
myocardial infraction	Stent, Medronic Resolute Integrity	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
Control	coronary angiography	Patients subjected to coronary angiography and found with no presence of coronary artery disease
coronary artery disease	Stent, Medronic Resolute Integrity	Patients with coronary artery disease but not myocardial infraction who are being subjected to coronary angiography and percutaneous coronary intervention and stent placement
coronary artery disease	percutaneous coronary intervention	Patients with coronary artery disease but not myocardial infraction who are being subjected to coronary angiography and percutaneous coronary intervention and stent placement

Primary Outcome Measures

Name	Time	Method
changes from baseline in serum irisin measured by ELISA	baseline and 6 hours or 24 hours

Secondary Outcome Measures

Name	Time	Method
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
changes from baseline in serum Activin B	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 follistatin-like protein 3 (FSTL-3)	baseline and 6 hours or 24 hours
changes from baseline in serum pico pregnancy-associated plasma protein A (PAPP-A)	baseline and 6 hours or 24 hours
changes from baseline in serum insulin growth factor 1 (IGF1)	baseline and 6 hours or 24 hours
changes from baseline in serum Activin A	baseline and 6 hours or 24 hours
changes from baseline in serum insulin growth factor binding protein 3 (IGFBP3)	baseline and 6 hours or 24 hours
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 insulin growth factor binding protein 4 (IGFBP4)	baseline and 6 hours or 24 hours

Trial Locations

Locations (1)

424 General Military Hospital; 🇬🇷 Thessaloniki, Greece