The Relationship Between Myonectin Concentration and the Course of ST-segment Elevation Myocardial Infarction

Study Overview
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Brief Summary
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The aim of this study is to test the potentially protective role of myonectin in patients with a first episode of ST elevation myocardial infarction (MI) treated with primary percutaneous coronary intervention (PCI). The main questions which are assumed to be answered after study completion: Does higher myonectin concentration influence the in-hospital and 30-day course of the first ST-elevation MI in patients treated with primary coronary angioplasty Is there a relationship between the serum myonectin concentration, related to patient's nutritional status and physical activity with the patient's physical activity declared as usually before the coronary event occurrence, the cardiac biomarkers level, and myocardial and skeletal muscle mass determined in order to objectify the relationship of physical activity before the infarction with 30-day and one-year mortality, and the other primary and secondary outcomes measured at 12-month visit, e.g. the extent of myocardial infarction, Is there a relationship between the baseline concentration of myonectin and troponin with the control of atherosclerosis risk factors, declared physical activity and parameters of body composition, outcome of treadmill exercise test, values of echocardiographic parameters and myonectin concentration 12 months after a cardiovascular incident

Detailed Description
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Myonectin or Complement C1q Tumor Necrosis Factor - Related Protein 15 (CTRP15) is a cytokine secreted by skeletal muscle. The participation of myonectin in the regulation of lipid homeostasis in the liver and adipose tissue has been proven. The concentration of myonectin depends on the nutritional status of the organism, it decreases during fasting and increases after feeding. In studies on mice, a protective effect of high concentrations of myonectin on the course of myocardial infarction was observed. The effect of regular physical exercise on the concentration of myonectin in the serum was also demonstrated. Abnormal function of myokines, including myonectin, has also been linked to sarcopenia, which significantly negatively affects the prognosis of patients with heart failure. Potentially protective properties of myonectin in the case of ischemia-reperfusion injury in the course of myocardial infarction have not been studied in humans so far. Myonectin may become a potentially useful prognostic indicator of the severity of myocardial infarction. It may also potentially become a target for a new cardioprotective therapy in patients with acute myocardial ischaemia.

Official Title
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Assessing the Relationship Between Myonectin Concentration and the Course of Hospitalization and the 30-day Risk of Cardiac Endpoints in Patients With the First Incident of ST-segment Elevation Mycardial Infarction Treated With Primary PCI

Conditions
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ST Elevation Myocardial Infarction

Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: symptoms of acute coronary syndrome acute ST segment elevation in two or more leads in ECG primary PCI Exclusion Criteria: pregnancy patients unconscious, with altered consciousness or not able to cooperate cardiogenic shock significant physical effort within 24 hours before onset of MI active infection at admission, intramuscular injection myocardial infarction in patient's medical history heart failure New York Heart Association (NYHA) class III - IV in patient's medical history renal failure (chronic kidney disease, CKD) with glomerular filtration rate (GFR) < 30ml/min history of malignant neoplasms in the last 5 years patients incapacitated, active soldiers, imprisoned or related with investigators

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 80 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 30-day mortality | All-cause mortality | 30 days | 
| 12-month mortality | All-cause mortality | 12 months | 
| Myocardial infarction | Any myocardial infarction during follow-up | 12 months | 
| Stroke | Any stroke or transient ischaemic attack (TIA) during follow-up | 12 months | 
| Bleeding | Any registered clinically significant bleeding | 12 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Left Ventricular Ejection Fraction | Left Ventricular Ejection Fraction in echocardiography, the absolute value and change after 12 months | up to 7 days and 12 months | 
| Cardiac Troponin T | Highest registered concentration of high sensitive Cardiac Troponin T during hospitalization | up to 7 days | 
| Left Ventricular Internal Dimension at End of Diastole (LVIDd) | Left Ventricular Internal Dimension at End of Diastole (LVIDd) in echocardiography, the absolute value and change after 12 months | up to 7 days and 12 months | 
| Length of hospitalization | Length of in-hospital stay (LOS) | 30 days | 
| Myonectin serum concentration | Change of myonectin concentration after 12 months | up to 7 days and 12 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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myonectin, CTRP15, primary percutaneous coronary intervention, troponin concentration, ejection fraction, echocardiography, 30-day mortality, One-year mortality, Physical Activity Questionnaire Short Form, skeletal muscle mass