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ST Elevation Myocardial InfarctionNCT05700773

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

An observational study of ST Elevation Myocardial Infarction, run by Michał Jaśkiewicz at 1 site in Poland.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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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. Read more about this study

Who is it for?
Ages 18 to 80 years
Conditions the study is for
ST Elevation Myocardial Infarction
How many people
100 participants
Where
1 sitePoland
Study dates
1 Jan 2023to 31 May 2026
Phase
Observational
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 80 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

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.

Who may be able to join

  • symptoms of acute coronary syndrome
  • acute ST segment elevation in two or more leads in ECG
  • primary PCI

Who cannot join

  • 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
Show all 10Show fewer
  • 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

Trial locations and contacts

1 site in 1 country.

Michał Jaśkiewicz, MD contact

+48 606613129

mich.jask@gmail.com

Poland1 site, 1 recruiting

  • Voivodeship Hospital in Elblag

    Elblag, Warmian-Masurian Voivodeship, 82-300

    Michal Jaskiewicz, MD, +606613129, mich.jask@gmail.com

    Recruiting

Other trials in Poland

About this study

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

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
Read the 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.

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
Medical subject headings
ST Elevation Myocardial Infarction

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 30-day mortality

    All-cause mortality

    Measured: 30 days

  2. 12-month mortality

    All-cause mortality

    Measured: 12 months

  3. Myocardial infarction

    Any myocardial infarction during follow-up

    Measured: 12 months

  4. Stroke

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

    Measured: 12 months

  5. Bleeding

    Any registered clinically significant bleeding

    Measured: 12 months

Secondary outcomes (5)

  1. Left Ventricular Ejection Fraction

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

    Measured: up to 7 days and 12 months

  2. Cardiac Troponin T

    Highest registered concentration of high sensitive Cardiac Troponin T during hospitalization

    Measured: up to 7 days

  3. 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

    Measured: up to 7 days and 12 months

  4. Length of hospitalization

    Length of in-hospital stay (LOS)

    Measured: 30 days

  5. Myonectin serum concentration

    Change of myonectin concentration after 12 months

    Measured: up to 7 days and 12 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted26 Jan 2023
  2. Study start1 Jan 2023
  3. Primary completion31 Dec 2025 (estimated)
  4. Study completion31 May 2026 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Case only
Time perspective
Prospective
Enrolment
100 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05700773
Sponsor's protocol ID
wszz0001
Status last verified
Apr 2024
First submitted
26 Dec 2022
Last updated
30 Apr 2024
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Undecided

Questions about this trial

What is this clinical trial studying?

An observational study of ST Elevation Myocardial Infarction, run by Michał Jaśkiewicz at 1 site in Poland.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 3 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: status not confirmed, as of the sponsor's last update on 30 Apr 2024. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Poland. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

Contact Michał Jaśkiewicz, MD (+48 606613129, mich.jask@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

30-day mortality (time frame: 30 days). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05700773.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Apr 2024.

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