Clinical trial NCT05700773: The Relationship Between Myonectin Concentration and the Course of ST-segment Elevation Myocardial Infarction
Official title: 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
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: ST Elevation Myocardial Infarction
Keywords: 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
Lead sponsor: Wojewodzki Szpital Zespolony w Elblagu
Sponsor class: OTHER
Collaborators: name: Jan Biziel University Hospital No 2 in Bydgoszcz
First posted: 2023-01-26
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: All patients admitted to the study site with a diagnosis of STEMI treated with primary PCI who consent to follow-up during the scheduled enrollment window.

Brief summary: 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:

1. 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
2. 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,
3. 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: 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.

Eligibility criteria: 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

Primary outcomes:
measure: 30-day mortality
timeFrame: 30 days
measure: 12-month mortality
timeFrame: 12 months
measure: Myocardial infarction
timeFrame: 12 months
measure: Stroke
timeFrame: 12 months
measure: Bleeding
timeFrame: 12 months
Secondary outcomes:
measure: Left Ventricular Ejection Fraction
timeFrame: up to 7 days and 12 months
measure: Cardiac Troponin T
timeFrame: up to 7 days
measure: Left Ventricular Internal Dimension at End of Diastole (LVIDd)
timeFrame: up to 7 days and 12 months
measure: Length of hospitalization
timeFrame: 30 days
measure: Myonectin serum concentration
timeFrame: up to 7 days and 12 months
Other outcomes:
Locations:
city: Elblag
country: Poland
facility: Voivodeship Hospital in Elblag
state: Warminsko-mazurskie
Study officials:
affiliation: Voivodeship Hospital in Elblag, Poland; Department of Cardiology
name: Michał Jaśkiewicz, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Jan Biziel University Hospital No 2 in Bydgoszcz, Poland; Department of Vascular and Internal Diseases, Nicolaus Copernicus University in Torun, Collegium Medicum in Bydgoszcz, Poland
name: Jacek Budzyński, MD PhD
role: PRINCIPAL_INVESTIGATOR
References: