Myocardial InfarctionIRICARDIONCT02498431

Serum Irisin in Myocardial Infraction and Following Percutaneous Coronary Intevention

A study testing percutaneous coronary intervention, coronary angiography and Stent, Medronic Resolute Integrity in people with Myocardial Infarction and Coronary Artery Disease, run by 424 General Military Hospital at 1 site in Greece.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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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. Read more about this study

Who is it for?: Ages 30 to 80 years
Conditions the study is for: Myocardial Infarction, Coronary Artery Disease
What is being tested?: percutaneous coronary intervention, coronary angiography and Stent, Medronic Resolute Integrity
Type of treatment: Medical device, Surgery or procedure
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 116 participants
Where: 1 siteGreece
Study dates: Jun 2015to Dec 2015
Phase: Interventional
Are there results?: None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 30 to 80 years
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

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

Who cannot join

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

Trial locations and contacts

1 site in 1 country.

Greece1 site

424 General Military Hospital
Thessaloniki, 56429

Other trials in Greece

About this study

Official title: Serum Irisin Levels in Myocardial Infraction and Following Percutaneous Coronary Intevention

Read the 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

Conditions: Myocardial Infarction, Coronary Artery Disease
Being tested: percutaneous coronary intervention, coronary angiography, Stent, Medronic Resolute Integrity
Keywords: irisin, myocardial infarction, coronary
Medical subject headings: Myocardial Infarction, Coronary Artery Disease

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

percutaneous coronary interventionProcedure or surgery
Also called coronary angioplasty
a non-surgical procedure used to treat the stenotic (narrowed) coronary arteries of the heart found in coronary heart disease
coronary angiographyProcedure or surgery
is a procedure performed along with cardiac catheterization that uses X-ray imaging to see your heart's blood vessels
Stent, Medronic Resolute IntegrityDevice
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.

Study groups in NCT02498431
Study group	Role	What they receive
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 Receives: 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 Receives: 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 Receives: Procedure: coronary angiography

What is being measured

The primary outcome is the main question the study is designed to answer.

changes from baseline in serum irisin measured by ELISA
Measured: baseline and 6 hours or 24 hours

Secondary outcomes (12)

changes from baseline in troponin
Measured: baseline and 6 hours or 24 hours
changes from baseline in serum lactate dehydrogenase
Measured: baseline and 6 hours or 24 hours
changes from baseline in serum creatine kinase
Measured: baseline and 6 hours or 24 hours
changes from baseline in serum creatine kinase-MB isoenzyme
Measured: baseline and 6 hours or 24 hours
changes from baseline in serum follistatin
Measured: baseline and 6 hours or 24 hours
changes from baseline in serum follistatin-like protein 3 (FSTL-3)
Measured: baseline and 6 hours or 24 hours
changes from baseline in serum Activin A
Measured: baseline and 6 hours or 24 hours
changes from baseline in serum Activin B
Measured: baseline and 6 hours or 24 hours
changes from baseline in serum insulin growth factor 1 (IGF1)
Measured: baseline and 6 hours or 24 hours
changes from baseline in serum insulin growth factor binding protein 3 (IGFBP3)
Measured: baseline and 6 hours or 24 hours
changes from baseline in serum insulin growth factor binding protein 4 (IGFBP4)
Measured: baseline and 6 hours or 24 hours
changes from baseline in serum pico pregnancy-associated plasma protein A (PAPP-A)
Measured: baseline and 6 hours or 24 hours

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Jun 2015Dec 2015

First posted15 Jul 2015 (estimated)
Study startJun 2015
Primary completionDec 2015
Study completionDec 2015

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Publications (7)Papers the sponsor has linked to this study.
Other trials for Myocardial InfarctionStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase N/A
Primary purpose: Diagnosis
Allocation: Non-randomised
Intervention model: Parallel groups
Masking: None (open label)
Enrolment: 116 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT02498431
Sponsor's protocol ID: IRICARDIO
Acronym: IRICARDIO
Status last verified: Jan 2017
First submitted: 8 Jul 2015
Last updated: 18 Jan 2017
Results posted: No
Data monitoring committee: No

Publications

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.
PubMed 22237023
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.
PubMed 23219488
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.
PubMed 23018146
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.
PubMed 24345335
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.
PubMed 24576483
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.
PubMed 24747283
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.
PubMed 24916788

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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All Myocardial Infarction trials

Study at a glance

From the registry record, last updated by the sponsor on 18 Jan 2017. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Serum Irisin Levels in Myocardial Infraction and Following Percutaneous Coronary Intevention
ClinicalTrials.gov ID: NCT02498431
Acronym / sponsor ID: IRICARDIO / IRICARDIO
Conditions: Myocardial Infarction, Coronary Artery Disease
Keywords: irisin, myocardial infarction, coronary
Study type: Interventional
Recruitment status: Completed
Enrolment: 116 participants (actual)
Lead sponsor: 424 General Military HospitalUniversity, hospital or other
Study start: Jun 2015
Primary completion: Dec 2015 (actual)
Study completion: Dec 2015 (actual)
First posted: 15 Jul 2015 (estimated)
Results: Not posted in the source record

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Detailed description

Study design

Primary purpose: Diagnosis
Allocation: Non-randomised
Intervention model: Parallel groups
Masking: None (open label)
Number of arms: 3

Arm	Type	Receives
myocardial infraction	Experimental	Procedure: percutaneous coronary intervention, Procedure: coronary angiography, Device: Stent, Medronic Resolute IntegrityPatients 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	Active comparator	Procedure: percutaneous coronary intervention, Procedure: coronary angiography, Device: Stent, Medronic Resolute IntegrityPatients with coronary artery disease but not myocardial infraction who are being subjected to coronary angiography and percutaneous coronary intervention and stent placement
Control	Active comparator	Procedure: coronary angiographyPatients subjected to coronary angiography and found with no presence of coronary artery disease

Who may qualify

Ages: 30 to 80 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (1 listed)

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

Key exclusion criteria (4 listed)

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

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
percutaneous coronary interventionAlso: coronary angioplastya non-surgical procedure used to treat the stenotic (narrowed) coronary arteries of the heart found in coronary heart disease	Procedure or surgery	coronary artery disease, myocardial infraction
coronary angiographyis a procedure performed along with cardiac catheterization that uses X-ray imaging to see your heart's blood vessels	Procedure or surgery	Control, coronary artery disease, myocardial infraction
Stent, Medronic Resolute IntegrityA 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.	Device	coronary artery disease, myocardial infraction

Primary outcome

changes from baseline in serum irisin measured by ELISA
Time frame: baseline and 6 hours or 24 hours

12 secondary outcomes

changes from baseline in troponin
Time frame: baseline and 6 hours or 24 hours
changes from baseline in serum lactate dehydrogenase
Time frame: baseline and 6 hours or 24 hours
changes from baseline in serum creatine kinase
Time frame: baseline and 6 hours or 24 hours
changes from baseline in serum creatine kinase-MB isoenzyme
Time frame: baseline and 6 hours or 24 hours
changes from baseline in serum follistatin
Time frame: baseline and 6 hours or 24 hours
changes from baseline in serum follistatin-like protein 3 (FSTL-3)
Time frame: baseline and 6 hours or 24 hours
changes from baseline in serum Activin A
Time frame: baseline and 6 hours or 24 hours
changes from baseline in serum Activin B
Time frame: baseline and 6 hours or 24 hours
changes from baseline in serum insulin growth factor 1 (IGF1)
Time frame: baseline and 6 hours or 24 hours
changes from baseline in serum insulin growth factor binding protein 3 (IGFBP3)
Time frame: baseline and 6 hours or 24 hours
changes from baseline in serum insulin growth factor binding protein 4 (IGFBP4)
Time frame: baseline and 6 hours or 24 hours
changes from baseline in serum pico pregnancy-associated plasma protein A (PAPP-A)
Time frame: baseline and 6 hours or 24 hours

Results and safety

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 18 Jan 2017.
Background: PubMed 22237023Bostrom 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.
Background: PubMed 23219488Stengel 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.
Background: PubMed 23018146Huh 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.
Background: PubMed 24345335Aydin 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.
Background: PubMed 24576483Kuloglu 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.
Background: PubMed 24747283Aydin 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.
Background: PubMed 24916788Aronis 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.

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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Athanasios D Anastasilakis, PhD principal investigator

424 General Military Hospital

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 1 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 18 Jan 2017. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Greece. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

changes from baseline in serum irisin measured by ELISA (time frame: baseline and 6 hours or 24 hours). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02498431, which also lists 7 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Jan 2017; AzTrials last refreshed its copy on 8 Nov 2026.