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

Sponsor
Michał Jaśkiewicz (Other)
Overall Status
Recruiting
CT.gov ID
NCT05700773
Collaborator
Jan Biziel University Hospital No 2 in Bydgoszcz (Other)
100
1
28.9
3.5

Study Details

Study Description

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

Condition or Disease Intervention/Treatment Phase

    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 Design

    Study Type:
    Observational
    Anticipated Enrollment :
    100 participants
    Observational Model:
    Case-Only
    Time Perspective:
    Prospective
    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
    Actual Study Start Date :
    Jan 1, 2023
    Anticipated Primary Completion Date :
    Dec 31, 2024
    Anticipated Study Completion Date :
    May 31, 2025

    Outcome Measures

    Primary Outcome Measures

    1. 30-day mortality [30 days]

      All-cause mortality

    2. 12-month mortality [12 months]

      All-cause mortality

    3. Myocardial infarction [12 months]

      Any myocardial infarction during follow-up

    4. Stroke [12 months]

      Any stroke or transient ischaemic attack (TIA) during follow-up

    5. Bleeding [12 months]

      Any registered clinically significant bleeding

    Secondary Outcome Measures

    1. Left Ventricular Ejection Fraction [up to 7 days and 12 months]

      Left Ventricular Ejection Fraction in echocardiography, the absolute value and change after 12 months

    2. Cardiac Troponin T [up to 7 days]

      Highest registered concentration of high sensitive Cardiac Troponin T during hospitalization

    3. Left Ventricular Internal Dimension at End of Diastole (LVIDd) [up to 7 days and 12 months]

      Left Ventricular Internal Dimension at End of Diastole (LVIDd) in echocardiography, the absolute value and change after 12 months

    4. Length of hospitalization [30 days]

      Length of in-hospital stay (LOS)

    5. Myonectin serum concentration [up to 7 days and 12 months]

      Change of myonectin concentration after 12 months

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years to 80 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    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

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Voivodeship Hospital in Elblag Elblag Warminsko-mazurskie Poland 82-300

    Sponsors and Collaborators

    • Michał Jaśkiewicz
    • 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 Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Michał Jaśkiewicz, Principal Investigator; Consultant in Interventional Cardiology, Wojewodzki Szpital Zespolony w Elblagu
    ClinicalTrials.gov Identifier:
    NCT05700773
    Other Study ID Numbers:
    • wszz0001
    First Posted:
    Jan 26, 2023
    Last Update Posted:
    Jan 26, 2023
    Last Verified:
    Jan 1, 2023
    Individual Participant Data (IPD) Sharing Statement:
    Undecided
    Plan to Share IPD:
    Undecided
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Keywords provided by Michał Jaśkiewicz, Principal Investigator; Consultant in Interventional Cardiology, Wojewodzki Szpital Zespolony w Elblagu
    Additional relevant MeSH terms:

    Study Results

    No Results Posted as of Jan 26, 2023