TROPOnin FRAGMentation in Myocardial Injury Study
Tropo-Fragm
Troponin T Fragmentation in the Assessment of Myocardial Injury Study
1 other identifier
observational
1,500
2 countries
2
Brief Summary
Troponin T (TnT) is a part of the troponin protein complex that principally exists in cardiac and skeletal muscle cells and is widely used as diagnostic biomarker for myocardial injury and, thus, myocardial infarction (MI). Elevated TnT levels can, however, be observed in the presence of other clinical conditions such as heart failure, sepsis and kidney failure and the contemporary high-sensitivity TnT test may yield false positive results when performing diagnostics for suspected MI in these patients. Recent data have demonstrated that in the presence of MI, TnT gradually undergoes fragmentation into smaller fragments. It has been suggested that in the presence of e.g. chronic kidney disease or physical exercise the released TnT is predominantly in the form of smaller fragments. However, the clinical significance of TnT fragmentation is unknown and, thus, we sought to investigate the prevalence of fragmentation of TnT in different patient cohorts.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started Apr 2020
Longer than P75 for all trials
2 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
April 2, 2020
CompletedFirst Submitted
Initial submission to the registry
July 7, 2020
CompletedFirst Posted
Study publicly available on registry
July 10, 2020
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 30, 2026
ExpectedStudy Completion
Last participant's last visit for all outcomes
December 31, 2026
August 14, 2023
August 1, 2023
6.7 years
July 7, 2020
August 11, 2023
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
The fragmentation rate of Troponin T
The proportion of fragmented Troponin T in patient cohort.
Baseline
Study Arms (2)
Myocardial infarction
Recruited patients with STEMI or NSTEMI and elevated Troponin T
Myocardial injury
Recruited patients with myocardial injury based on elevated Troponin T and associated with renal failure, severe infection, strenouos exercise, atrial fibrillation, myocarditis, takotsubo cardiomyopathy or other similar conditions
Interventions
laboratory test from blood sample
Eligibility Criteria
Patients are prospectively recruited from the Heart Center, Department of Medicine and Kidney Center of the study hospital. All patients aged 18 years are eligible.
You may qualify if:
- Troponin T fragmentation sample collected from a recruited patient.
You may not qualify if:
- Age \<18
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (2)
Turku University Hospital, Heart Center
Turku, Southwest Finland, 20521, Finland
University Hospital Zurich
Zurich, 8091 Zurich, Switzerland
Related Publications (4)
Aalto R, Lahtinen A, Airaksinen KEJ, Vasankari T, Hellman T, Koskimaki L, Wittfooth S. Design and Analytical Evaluation of an Immunoassay for Long Forms of Cardiac Troponin T. J Appl Lab Med. 2026 Jan 5;11(1):36-47. doi: 10.1093/jalm/jfaf143.
PMID: 41025697DERIVEDAiraksinen JKE, Tuominen T, Paana T, Hellman T, Vasankari T, Salonen S, Junes H, Linko-Parvinen A, Pallari HM, Strandberg M, Teppo K, Jaakkola S, Wittfooth S. Novel troponin fragmentation assay to discriminate between Takotsubo syndrome and acute myocardial infarction. Eur Heart J Acute Cardiovasc Care. 2024 Dec 3;13(11):782-788. doi: 10.1093/ehjacc/zuae115.
PMID: 39422200DERIVEDSalonen SM, Tuominen TJK, Raiko KIS, Vasankari T, Aalto R, Hellman TA, Lahtinen SE, Soukka T, Airaksinen KEJ, Wittfooth ST. Highly Sensitive Immunoassay for Long Forms of Cardiac Troponin T Using Upconversion Luminescence. Clin Chem. 2024 Aug 1;70(8):1037-1045. doi: 10.1093/clinchem/hvae075.
PMID: 38888909DERIVEDAiraksinen KEJ, Aalto R, Hellman T, Vasankari T, Lahtinen A, Wittfooth S. Novel Troponin Fragmentation Assay to Discriminate Between Troponin Elevations in Acute Myocardial Infarction and End-Stage Renal Disease. Circulation. 2022 Nov;146(18):1408-1410. doi: 10.1161/CIRCULATIONAHA.122.060845. Epub 2022 Oct 31. No abstract available.
PMID: 36315607DERIVED
Biospecimen
Heparin plasma: * Troponin T control sample * Troponin T fragmentation sample
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Juhani K Airaksinen, MD, PhD
University of Turku
Central Study Contacts
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- CROSS SECTIONAL
- Target Duration
- 1 Year
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Professor
Study Record Dates
First Submitted
July 7, 2020
First Posted
July 10, 2020
Study Start
April 2, 2020
Primary Completion (Estimated)
December 30, 2026
Study Completion (Estimated)
December 31, 2026
Last Updated
August 14, 2023
Record last verified: 2023-08