Clinical trial NCT03735719: Biomarkers for Risk Stratification After STEMI
Official title: Biomarkers for Risk Stratification of Patients With ST-elevation Myocardial Infarction Treated With Primary Percutaneous Coronary Intervention
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Biomarkers
ST Segment Elevation Myocardial Infarction
Primary Percutaneous Coronary Intervention
Heart Diseases
Cardiovascular Diseases
Pathologic Processes
Heart Failure
Keywords: soluble ST2
galectin-3
prognosis
STEMI
primary PCI
Lead sponsor: Medical University of Warsaw
Sponsor class: OTHER
First posted: 2018-11-08
Enrollment: 136
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Study will include patients with first ST-elevation myocardial infarction treated with primary percutaneous coronary intervention.

Brief 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.

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Biomarker-related risk stratification of heart failure occurrence after STEMI treated with PCI.
timeFrame: 12 months after STEMI
measure: Biomarker-related risk stratification of one-year death occurrence after STEMI treated with PCI.
timeFrame: 12 months after STEMI
measure: Biomarker-related risk stratification of cardiovascular hospitalization occurrence after STEMI treated with PCI.
timeFrame: 12 months after STEMI
measure: Biomarker-related risk stratification of left ventricular systolic dysfunction occurrence after STEMI treated with PCI.
timeFrame: 12 months after STEMI
measure: Biomarker-related risk stratification of left ventricular diastolic dysfunction occurrence after STEMI treated with PCI.
timeFrame: 12 months after STEMI
Secondary outcomes:
measure: Correlation of serum biomarkers concentrations with cardiac remodeling
timeFrame: 12 months after STEMI
measure: Correlation of serum biomarkers concentrations with a inflammation
timeFrame: 12-months observation
measure: comparison to control subjects
timeFrame: baseline assessment
Other outcomes:
Locations:
city: Warsaw
country: Poland
facility: 1st Chair and Department of Cardiology, Medical University of Warsaw
Study officials:
affiliation: 1st Chair and Department of Cardiology, Medical University of Warsaw
name: Agnieszka Kapłon-Cieślicka, PhD
role: STUDY_CHAIR
affiliation: 1st Chair and Department of Cardiology, Medical University of Warsaw
name: Grzegorz Opolski, Professor
role: STUDY_CHAIR
affiliation: 1st Chair and Department of Cardiology, Medical University of Warsaw
name: Krzysztof J Filipiak, Professor
role: STUDY_CHAIR
References:
citation: 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.
citation: 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.