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

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

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

Study Overview

• Status: Recruiting
• Conditions: ST Elevation Myocardial Infarction

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.

• Study Type: Observational
• Enrollment (Estimated): 100

Contacts and Locations

• Study Contact: Name: Michał Jaśkiewicz, MD; Phone Number: +48 606613129; Email: mich.jask@gmail.com

Study Locations

• Poland
  • Warminsko-mazurskie
    • Elblag, Warminsko-mazurskie, Poland, 82-300
      • Recruiting
      • Voivodeship Hospital in Elblag
      • Contact: Michal Jaskiewicz, MD; Phone Number: +606613129; Email: mich.jask@gmail.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 80 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No

• 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.

Description

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

Study Plan

How is the study designed?

Design Details

• Observational Models: Case-Only
• Time Perspectives: Prospective

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Michał Jaśkiewicz
• Collaborators: Jan Biziel University Hospital No 2 in Bydgoszcz
• Investigators: Principal Investigator: Michał Jaśkiewicz, MD, Voivodeship Hospital in Elblag, Poland; Department of Cardiology; Principal Investigator: Jacek Budzyński, MD PhD, 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

Study record dates

Study Major Dates

• Study Start (Actual): January 1, 2023
• Primary Completion (Estimated): December 31, 2025
• Study Completion (Estimated): May 31, 2026

Study Registration Dates

• First Submitted: December 26, 2022
• First Submitted That Met QC Criteria: January 17, 2023
• First Posted (Actual): January 26, 2023

Study Record Updates

• Last Update Posted (Actual): April 30, 2024
• Last Update Submitted That Met QC Criteria: April 27, 2024
• Last Verified: April 1, 2024

More Information

Terms related to this study

• Keywords: echocardiography; ejection fraction; skeletal muscle mass; primary percutaneous coronary intervention; 30-day mortality; myonectin; CTRP15; troponin concentration; One-year mortality; Physical Activity Questionnaire Short Form
• Additional Relevant MeSH Terms: Ischemia; Pathologic Processes; Necrosis; Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Vascular Diseases; Myocardial Infarction; Infarction; ST Elevation Myocardial Infarction
• Other Study ID Numbers: wszz0001

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No