Biomarkers for Risk Stratification After STEMI

September 30, 2019 updated by: Medical University of Warsaw

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.

Study Overview

Status

Unknown

Conditions

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.

Study Type

Observational

Enrollment (Actual)

136

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Poland
      • Warsaw, Poland, 02-097
        • 1st Chair and Department of Cardiology, Medical University of Warsaw

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Probability Sample

Study Population

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

Description

Inclusion Criteria:

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

Exclusion Criteria:

  • 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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
STEMI patients
Patients with first STEMI treated with primary PCI are recruited in this study.
Control group
The control group will consist of patients with risk factors for cardiovascular diseases, but without history of coronary artery disease or heart failure.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Biomarker-related risk stratification of heart failure occurrence after STEMI treated with PCI.
Time Frame: 12 months after STEMI
Assessment of the prognostic value of Gal-3 and ST-2 in prediction of developing heart failure in one year observation after STEMI.
12 months after STEMI
Biomarker-related risk stratification of one-year death occurrence after STEMI treated with PCI.
Time Frame: 12 months after STEMI
Assessment of the prognostic value of Gal-3 and ST-2 in prediction of death in one year observation after STEMI.
12 months after STEMI
Biomarker-related risk stratification of cardiovascular hospitalization occurrence after STEMI treated with PCI.
Time Frame: 12 months after STEMI
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.
12 months after STEMI
Biomarker-related risk stratification of left ventricular systolic dysfunction occurrence after STEMI treated with PCI.
Time Frame: 12 months after STEMI
Assessment of the prognostic value of Gal-3 and ST-2 in prediction of left ventricular systolic dysfunction in one year observation after STEMI.
12 months after STEMI
Biomarker-related risk stratification of left ventricular diastolic dysfunction occurrence after STEMI treated with PCI.
Time Frame: 12 months after STEMI
Assessment of the prognostic value of Gal-3 and ST-2 in prediction of left ventricular diastolic dysfunction in one year observation after STEMI.
12 months after STEMI

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Correlation of serum biomarkers concentrations with cardiac remodeling
Time Frame: 12 months after STEMI
Assessment of the correlation between Gal-3 and ST-2 with a size of an infarct scar and echocardiographic parameters
12 months after STEMI
Correlation of serum biomarkers concentrations with a inflammation
Time Frame: 12-months observation
Assessment of the correlation between Gal-3 and ST-2 with other biomarkers of inflammation (e.g C-reactive protein).
12-months observation
comparison to control subjects
Time Frame: baseline assessment
Assessment of Gal-3 and ST-2 concentrations in comparison to the control group.
baseline assessment

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Medical University of Warsaw

Investigators

  • Study Chair: Agnieszka Kapłon-Cieślicka, PhD, 1st Chair and Department of Cardiology, Medical University of Warsaw
  • Study Chair: Grzegorz Opolski, Professor, 1st Chair and Department of Cardiology, Medical University of Warsaw
  • Study Chair: Krzysztof J Filipiak, Professor, 1st Chair and Department of Cardiology, Medical University of Warsaw

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

April 1, 2014

Primary Completion (Actual)

May 1, 2018

Study Completion (Anticipated)

January 1, 2021

Study Registration Dates

First Submitted

November 5, 2018

First Submitted That Met QC Criteria

November 7, 2018

First Posted (Actual)

November 8, 2018

Study Record Updates

Last Update Posted (Actual)

October 1, 2019

Last Update Submitted That Met QC Criteria

September 30, 2019

Last Verified

November 1, 2018

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • BIOSTRAT

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

IPD Plan Description

The investigators will be able to share data for meta-analyses

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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