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NCT Number: NCT02498431

Serum Irisin in Myocardial Infraction and Following Percutaneous Coronary Intevention

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.

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Key information

Conditions

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

Age range

30 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

424 General Military Hospital

Thessaloniki, 56429, Greece

About this study

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

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Percutaneous coronary intervention

Procedure

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

Other names: coronary angioplasty

Coronary Angiography

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

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.

Primary outcomes

  1. changes from baseline in serum irisin measured by ELISA

    Time frame: baseline and 6 hours or 24 hours

Secondary outcomes

  1. changes from baseline in troponin

    Time frame: baseline and 6 hours or 24 hours

  2. changes from baseline in serum lactate dehydrogenase

    Time frame: baseline and 6 hours or 24 hours

  3. changes from baseline in serum creatine kinase

    Time frame: baseline and 6 hours or 24 hours

  4. changes from baseline in serum creatine kinase-MB isoenzyme

    Time frame: baseline and 6 hours or 24 hours

  5. changes from baseline in serum follistatin

    Time frame: baseline and 6 hours or 24 hours

  6. changes from baseline in serum follistatin-like protein 3 (FSTL-3)

    Time frame: baseline and 6 hours or 24 hours

  7. changes from baseline in serum Activin A

    Time frame: baseline and 6 hours or 24 hours

  8. changes from baseline in serum Activin B

    Time frame: baseline and 6 hours or 24 hours

  9. changes from baseline in serum insulin growth factor 1 (IGF1)

    Time frame: baseline and 6 hours or 24 hours

  10. changes from baseline in serum insulin growth factor binding protein 3 (IGFBP3)

    Time frame: baseline and 6 hours or 24 hours

  11. changes from baseline in serum insulin growth factor binding protein 4 (IGFBP4)

    Time frame: baseline and 6 hours or 24 hours

  12. changes from baseline in serum pico pregnancy-associated plasma protein A (PAPP-A)

    Time frame: baseline and 6 hours or 24 hours

Sponsors and collaborators

Lead sponsor

424 General Military Hospital

Other

Registry information

Official study title

Serum Irisin Levels in Myocardial Infraction and Following Percutaneous Coronary Intevention

Acronym: IRICARDIO

Important dates

Study start
2015
Primary completion
2015
Study completion
2015
First posted
Jul 15, 2015
Registry last updated
Jan 18, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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