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

NCT05700773 | Recruiting

• 1 other identifier: wszz0001
• Study Type: observational
• Target: 100
• Locations: 1 country
• Sites: 1

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. 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. 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. 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

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

Outcome Measures

Primary Outcomes (5)

• 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 Outcomes (5)

• Left Ventricular Ejection Fraction

  up to 7 days and 12 months

• Cardiac Troponin T

  up to 7 days

• Left Ventricular Internal Dimension at End of Diastole (LVIDd)

  up to 7 days and 12 months

• Length of hospitalization

  30 days

• Myonectin serum concentration

  up to 7 days and 12 months

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• Michał Jaśkiewicz: lead
• Jan Biziel University Hospital No 2 in Bydgoszcz: collaborator

Study Sites (1)

Voivodeship Hospital in Elblag

Elblag, Warmian-Masurian Voivodeship, 82-300, Poland

RECRUITING

Biospecimen

Retention: SAMPLES WITHOUT DNA

Serum

MeSH Terms

Conditions

ST Elevation Myocardial Infarction

Condition Hierarchy (Ancestors)

Myocardial Infarction; Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Vascular Diseases; Infarction; Ischemia; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Necrosis

Study Officials

• 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

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Michał Jaśkiewicz, MD

CONTACT

+48 606613129; mich.jask@gmail.com

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Principal Investigator; Consultant in Interventional Cardiology

Study Record Dates

• First Submitted: December 26, 2022
• First Posted: January 26, 2023
• Study Start: January 1, 2023
• Primary Completion: December 31, 2025
• Study Completion (Estimated): May 31, 2026
• Last Updated: April 30, 2024

Record last verified: 2024-04

Locations

PL (1)