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

ST Elevation Myocardial Infarction Clinical Trial

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05700773
• Other study ID #: wszz0001
• Status: Recruiting
• Start date: January 1, 2023
• Est. completion date: May 31, 2026

Study information

• Verified date: April 2024
• Source: Wojewodzki Szpital Zespolony w Elblagu
• Contact: Michal Jaskiewicz, MD
• Phone: +48 606613129
• Email: mich.jask[@]gmail.com
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 100
• Est. completion date: May 31, 2026
• Est. primary completion date: December 31, 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

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

Related Conditions & MeSH terms

• Infarction
• Myocardial Infarction
• ST Elevation Myocardial Infarction

Locations

Country	Name	City	State
Poland	Voivodeship Hospital in Elblag	Elblag	Warminsko-mazurskie

Sponsors (2)

Lead Sponsor	Collaborator
Michal Jaskiewicz	Jan Biziel University Hospital No 2 in Bydgoszcz

Country where clinical trial is conducted

Poland, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	30-day mortality	All-cause mortality	30 days
Primary	12-month mortality	All-cause mortality	12 months
Primary	Myocardial infarction	Any myocardial infarction during follow-up	12 months
Primary	Stroke	Any stroke or transient ischaemic attack (TIA) during follow-up	12 months
Primary	Bleeding	Any registered clinically significant bleeding	12 months
Secondary	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
Secondary	Cardiac Troponin T	Highest registered concentration of high sensitive Cardiac Troponin T during hospitalization	up to 7 days
Secondary	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
Secondary	Length of hospitalization	Length of in-hospital stay (LOS)	30 days
Secondary	Myonectin serum concentration	Change of myonectin concentration after 12 months	up to 7 days and 12 months