Biomarkers for Risk Stratification After STEMI

Heart Failure Clinical Trial

Official title:

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT03735719
• Other study ID #: BIOSTRAT
• Status: Active, not recruiting
• Start date: April 2014
• Est. completion date: January 2021

Study information

• Verified date: November 2018
• Source: Medical University of Warsaw
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical 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. 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.

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 136
• Est. completion date: January 2021
• Est. primary completion date: May 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Biomarkers
• Cardiovascular Diseases
• Heart Diseases
• Heart Failure
• Infarction
• Myocardial Infarction
• Pathologic Processes
• Primary Percutaneous Coronary Intervention
• ST Elevation Myocardial Infarction
• ST Segment Elevation Myocardial Infarction

Locations

Country	Name	City	State
Poland	1st Chair and Department of Cardiology, Medical University of Warsaw	Warsaw

Sponsors (1)

Lead Sponsor	Collaborator
Medical University of Warsaw

Country where clinical trial is conducted

Poland, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	12 months after STEMI
Primary	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.	12 months after STEMI
Primary	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.	12 months after STEMI
Primary	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.	12 months after STEMI
Primary	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.	12 months after STEMI
Secondary	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	12 months after STEMI
Secondary	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).	12-months observation
Secondary	comparison to control subjects	Assessment of Gal-3 and ST-2 concentrations in comparison to the control group.	baseline assessment