Biomarkers for Risk Stratification After STEMI
1 other identifier
observational
136
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for all trials
Started Apr 2014
Longer than P75 for all trials
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
April 1, 2014
CompletedPrimary Completion
Last participant's last visit for primary outcome
May 1, 2018
CompletedFirst Submitted
Initial submission to the registry
November 5, 2018
CompletedFirst Posted
Study publicly available on registry
November 8, 2018
CompletedStudy Completion
Last participant's last visit for all outcomes
January 1, 2021
CompletedOctober 1, 2019
November 1, 2018
4.1 years
November 5, 2018
September 30, 2019
Conditions
Keywords
Outcome Measures
Primary Outcomes (5)
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
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
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
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
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 Outcomes (3)
Correlation of serum biomarkers concentrations with cardiac remodeling
12 months after STEMI
Correlation of serum biomarkers concentrations with a inflammation
12-months observation
comparison to control subjects
baseline assessment
Study Arms (2)
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.
Eligibility Criteria
Study will include patients with first ST-elevation myocardial infarction treated with primary percutaneous coronary intervention.
You may qualify if:
- \>= 18 years
- signed consent
- first STEMI treated with PCI
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
1st Chair and Department of Cardiology, Medical University of Warsaw
Warsaw, 02-097, Poland
Related Publications (2)
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.
PMID: 31687050DERIVEDTyminska 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.
PMID: 31642446DERIVED
Biospecimen
From each patient will be collected 10 ml of venous blood which will be centrifugated to obtain serum.
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- 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
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
November 5, 2018
First Posted
November 8, 2018
Study Start
April 1, 2014
Primary Completion
May 1, 2018
Study Completion
January 1, 2021
Last Updated
October 1, 2019
Record last verified: 2018-11