NCT06000930

Brief Summary

Cardiac troponins are highly sensitive and specific biomarkers of cardiac injury and are in a key role in the diagnosis of acute myocardial infarction (MI). Minor troponin elevations are common after prolonged strenuous exercise without clinical symptoms of MI or myocardial injury. Importantly, currently used high-sensitivity troponin T (cTnT) test detects also smaller troponin fragments which may cause troponin elevation after exercise and lead to false diagnosis of MI. In the present study protocol, we compare the characteristics troponin release after marathon race and Type 1 MI with the improved version of our novel troponin fragmentation test (SuperTropo test) and the commercial cTnT test. A total of 65 recreational runners participating in the 2023 Paavo Nurmi Marathon in Turku are recruited. All participants give a blood sample during the post-race visit (within 30 min after finishing the marathon). A control group of 90 patients with acute Type 1 MI are recruited among patients admitted to Heart Centre of Turku University Hospital. Commercial cTnT and long troponin component of cTnT analyzed witha novel immunoassay are dtermined in all subjects to assess cTnT fragmentation. TYhe main aims of the study are: To assess how often cTnT is elevated after marathon running and which factors affect the cTnT rise? Is the fragmentation of troponin more common after marathon race compared with Type 1 MI and can the novel Supertropo test separate execise-induced troponin rise from those caused by MI ?

Trial Health

55
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
170

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Aug 2023

Geographic Reach
1 country

1 active site

Status
enrolling by invitation

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

First Submitted

Initial submission to the registry

August 13, 2023

Completed
6 days until next milestone

Study Start

First participant enrolled

August 19, 2023

Completed
2 days until next milestone

First Posted

Study publicly available on registry

August 21, 2023

Completed
1 year until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2024

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2024

Completed
Last Updated

May 8, 2024

Status Verified

May 1, 2024

Enrollment Period

1 year

First QC Date

August 13, 2023

Last Update Submit

May 7, 2024

Conditions

Keywords

exercisetroponinmyocardial infarctionmyocardial injury

Outcome Measures

Primary Outcomes (1)

  • Magnitude of Troponin fragmentation in the post-race and post-MI (<24h) blood samples

    Ratio of long troponin component to total troponin T in the post-race and post-MI (\<24h) blood sample

    < 1 hour after marathon race and < 24 hours after myocardial infarction

Study Arms (2)

marathon runners

Marathon runners

Diagnostic Test: Troponin fragmentation

myocardial infarction

Patients with Type 1 myocardial infarction

Diagnostic Test: Troponin fragmentation

Interventions

Troponin fragmentationDIAGNOSTIC_TEST

laboratory test from blood sample

marathon runnersmyocardial infarction

Eligibility Criteria

Age18 Years - 80 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Marathon runners and patients with acute myocardial infarction as a control group

You may qualify if:

  • participating marathon race or treated for Type 1 myocardial infarction and giving informed consent

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Turku

Turku, 20300, Finland

Location

Related Publications (1)

  • Airaksinen KEJ, Paana T, Vasankari T, Salonen S, Tuominen T, Linko-Parvinen A, Pallari HM, Hellman T, Teppo K, Heinonen OJ, Jaakkola S, Wittfooth S. Composition of cardiac troponin release differs after marathon running and myocardial infarction. Open Heart. 2024 Nov 17;11(2):e002954. doi: 10.1136/openhrt-2024-002954.

MeSH Terms

Conditions

Myocardial InfarctionMotor Activity

Condition Hierarchy (Ancestors)

Myocardial IschemiaHeart DiseasesCardiovascular DiseasesVascular DiseasesInfarctionIschemiaPathologic ProcessesPathological Conditions, Signs and SymptomsNecrosisBehavior

Study Officials

  • Juhani K Airaksinen, Md, PhD

    Turku University Hospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
CROSS SECTIONAL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

August 13, 2023

First Posted

August 21, 2023

Study Start

August 19, 2023

Primary Completion

September 1, 2024

Study Completion

September 1, 2024

Last Updated

May 8, 2024

Record last verified: 2024-05

Locations