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BiomarkersNCT03735719

Biomarkers for Risk Stratification After STEMI

An observational study of Biomarkers and ST Segment Elevation Myocardial Infarction, run by Medical University of Warsaw 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 The sponsor has not verified this record for over two years, so it may be out of date.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

Despite modern reperfusion strategies, myocardial infarction leads to deleterious processes resulting in left ventricular remodelling (LVR) and heart failure (HF). Several biomarkers i.e. galectin-3 (Gal-3) and soluble ST-2 protein are involved in LVR as a result of inflammatory processes and fibrosis. Read more about this study

Who is it for?
Ages 18 years and older
How many people
136 participants
Where
1 sitePoland
Study dates
Apr 2014to Jan 2021
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 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Study population: Study will include patients with first ST-elevation myocardial infarction treated with primary percutaneous coronary intervention.

Who may be able to join

  • >= 18 years
  • signed consent
  • first STEMI treated with PCI

Who cannot join

  • previous STEMI/non-STEMI,
  • pre-existing HF,
  • severe renal dysfunction (plasma creatinine level >220 mmol/L and/or creatinine clearance <30 mL/min),
  • severe liver disease,
  • chronic inflammatory disease,
  • current neoplastic disease,
  • life expectancy <1 year.

Trial locations and contacts

1 site in 1 country.

Poland1 site

  • 1st Chair and Department of Cardiology, Medical University of Warsaw

    Warsaw, 02-097

Other trials in Poland

About this study

Official title: Biomarkers for Risk Stratification of Patients With ST-elevation Myocardial Infarction Treated With Primary Percutaneous Coronary Intervention

Despite modern reperfusion strategies, myocardial infarction leads to deleterious processes resulting in left ventricular remodelling (LVR) and heart failure (HF). Several biomarkers i.e. galectin-3 (Gal-3) and soluble ST-2 protein are involved in LVR as a result of inflammatory processes and fibrosis. There is an evidence of a high prognostic value of both biomarkers in prediction of outcomes in HF patients. This study will further investigate the role of Gal-3 and ST-2 in patients with ST-segment elevation myocardial infarction (STEMI) treated with primary percutaneous coronary intervention (PCI) and without prior HF in prediction of unfavourable outcomes.

Read the detailed description

Heart failure is nowadays one of the leading problems in cardiology. Heart failure is associated with high morbidity and mortality, as well as high social costs, resulting mainly from a large number of hospitalizations. Galectin-3 and ST-2 have an important role in remodeling and fibrosis of the left ventricle, one of the key pathophysiological mechanisms leading to the development of heart failure. Galectin-3 is a protein secreted by activated macrophages, that stimulate inflammation and fibrosis of the myocardium. ST2 molecule is a soluble glycoprotein belonging to the family of interleukin-1 receptor, secreted by inflammatory cells, cardiomyocytes and endothelium. The ST2 has two clinically relevant isoforms - transmembrane (ST-2L, ST-2 ligand) and soluble (sST-2, soluble ST-2) circulating in the bloodstream. sST2 is present in the extracellular environment and through competitive binding with IL-33 prevents its connection with ST2L, and triggers myocardial fibrosis.

There is evidence of a prognostic value of both biomarkers in prediction of outcomes in heart failure patients. However, studies evaluating the role of Gal-3 and ST-2 in patients with ST-segment elevation myocardial infarction (STEMI) are lacking.

The study will include consecutive patients with first STEMI treated with percutaneous coronary intervention (PCI) in 1st Chair and Department of Cardiology, Medical University of Warsaw. The control group will consist of patients with risk factors for cardiovascular risk factors, but without history of coronary artery disease or heart failure. Patients will be followed for 12 months.

Blood will be sampled twice during the study: 72-96 hours after hospital admission and during a follow-up visit at 12 months. Blood will be collected for routine laboratory tests, Gal-3, ST-2 and other biomarkers: cardiac troponin I (cTnI), C-reactive protein (CRP) and N-terminal pro-B-type natriuretic peptide (NT-proBNP). Two-dimensional echocardiography will be performed 24-48 hours after PCI and during a follow-up visit at 12 months.

The aim of the study is to assess the prognostic value of Gal-3 and ST-2 in patients after first STEMI treated with PCI in prediction of left ventricular systolic and diastolic dysfunction, development of heart failure, need for cardiovascular hospitalization and death during one year follow-up after STEMI.

Furthermore, the baseline concentrations of biomarkers in the study and control groups will be compare.

Keywords
soluble ST2, galectin-3, prognosis, STEMI, primary PCI
Medical subject headings
ST Elevation Myocardial Infarction, Heart Diseases, Cardiovascular Diseases, Pathologic Processes, Heart Failure

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Study groups in NCT03735719
Study groupRoleWhat they receive
STEMI patientsPatients with first STEMI treated with primary PCI are recruited in this study.
Control groupThe control group will consist of patients with risk factors for cardiovascular diseases, but without history of coronary artery disease or heart failure.

What is being measured

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

  1. Biomarker-related risk stratification of heart failure occurrence after STEMI treated with PCI.

    Assessment of the prognostic value of Gal-3 and ST-2 in prediction of developing heart failure in one year observation after STEMI.

    Measured: 12 months after STEMI

  2. Biomarker-related risk stratification of one-year death occurrence after STEMI treated with PCI.

    Assessment of the prognostic value of Gal-3 and ST-2 in prediction of death in one year observation after STEMI.

    Measured: 12 months after STEMI

  3. Biomarker-related risk stratification of cardiovascular hospitalization occurrence after STEMI treated with PCI.

    Assessment of the prognostic value of Gal-3 and ST-2 in assessment of the risk of hospitalization for cardiovascular reasons in one year observation after STEMI.

    Measured: 12 months after STEMI

  4. Biomarker-related risk stratification of left ventricular systolic dysfunction occurrence after STEMI treated with PCI.

    Assessment of the prognostic value of Gal-3 and ST-2 in prediction of left ventricular systolic dysfunction in one year observation after STEMI.

    Measured: 12 months after STEMI

  5. Biomarker-related risk stratification of left ventricular diastolic dysfunction occurrence after STEMI treated with PCI.

    Assessment of the prognostic value of Gal-3 and ST-2 in prediction of left ventricular diastolic dysfunction in one year observation after STEMI.

    Measured: 12 months after STEMI

Secondary outcomes (3)

  1. Correlation of serum biomarkers concentrations with cardiac remodeling

    Assessment of the correlation between Gal-3 and ST-2 with a size of an infarct scar and echocardiographic parameters

    Measured: 12 months after STEMI

  2. Correlation of serum biomarkers concentrations with a inflammation

    Assessment of the correlation between Gal-3 and ST-2 with other biomarkers of inflammation (e.g C-reactive protein).

    Measured: 12-months observation

  3. comparison to control subjects

    Assessment of Gal-3 and ST-2 concentrations in comparison to the control group.

    Measured: baseline assessment

Timeline

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

  1. First posted8 Nov 2018
  2. Study startApr 2014
  3. Primary completionMay 2018
  4. Study completionJan 2021 (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
Cohort
Time perspective
Prospective
Enrolment
136 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03735719
Sponsor's protocol ID
BIOSTRAT
Status last verified
Nov 2018
First submitted
5 Nov 2018
Last updated
1 Oct 2019
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Undecided: The investigators will be able to share data for meta-analyses

Publications

  • Tyminska A, Kaplon-Cieslicka A, Ozieranski K, Budnik M, Wancerz A, Sypien P, Peller M, Balsam P, Opolski G, Filipiak KJ. Association of Galectin-3 and Soluble ST2, and Their Changes, with Echocardiographic Parameters and Development of Heart Failure after ST-Segment Elevation Myocardial Infarction. Dis Markers. 2019 Oct 10;2019:9529053. doi: 10.1155/2019/9529053. eCollection 2019.

    PubMed 31687050

  • Tyminska A, Kaplon-Cieslicka A, Ozieranski K, Budnik M, Wancerz A, Sypien P, Peller M, Maksym J, Balsam P, Opolski G, Filipiak KJ. Association of galectin-3 and soluble ST2 with in-hospital and 1-year outcomes in patients with ST-segment elevation myocardial infarction treated with primary percutaneous coronary intervention. Pol Arch Intern Med. 2019 Nov 29;129(11):770-780. doi: 10.20452/pamw.15030. Epub 2019 Oct 23.

    PubMed 31642446

Questions about this trial

What is this clinical trial studying?

An observational study of Biomarkers and ST Segment Elevation Myocardial Infarction, run by Medical University of Warsaw 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 7 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 1 Oct 2019. 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?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Biomarker-related risk stratification of heart failure occurrence after STEMI treated with PCI. (time frame: 12 months after STEMI). 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 NCT03735719, which also lists 2 linked publications.

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 1 Oct 2019.

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