Cardiac Troponin Fragmentation After Heavy Physical Exercise The MaraCat2 Study (MaraCat2)

August 18, 2023 updated by: Juhani Airaksinen, University of Turku

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 ?

Study Overview

Status

Enrolling by invitation

Conditions

Intervention / Treatment

Detailed Description

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.

Based on a small gel filtration chromatography study the released troponin in this condition seems to be predominantly in the form of small fragments. These smaller cytosolic troponin fragments may more easily traverse across cell membranes that have become leaky but not irreversibly damaged. Importantly, currently used high-sensitivity troponin T (cTnT) test detects also smaller troponin fragments which may lead to false diagnosis of MI.

In a Proof-of-Principle study we developed a novel immunoassay which is much simpler and more sensitive than previously used laboratory methods for studying cTnT fragmentation. 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 to the MaraCat2 Study with an open email invitation. All participants give a blood sample during the post-race visit (within 60 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. Coronary angiography is performed in all included patients to confirm culprit lesion and the MI diagnosis. All included patients are treated with primary or urgent percutaneous coronary intervention. Only patients with <24 delay from symptom onset to blood sample are included to avoid the effects of later gradual fragmentation of cTnT in the circulation.

Certified laboratory services by Turku University Hospital (TYKSLAB) take care of blood samples. After centrifugation, serum is aliquoted, frozen and stored at -70 °C for later analysis. Analysis is performed on a single day using the same calibration and set-up to minimize variation.

cTnT was analyzed using a commercial high-sensitive assay (Roche Diagnostics GmbH, Mannheim, Germany).

A novel sensitive time-resolved immunofluorometric assay is used for the detection of long cTnT forms (long cTnT). The long cTnT assay follows the sandwich type immunoassay format and utilizes time-resolved-fluorescence (TRF) as the measurement platform.

The 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 complex (assessed by long cTnT/ total cTnT ratio) more common after marathon race compared with Type 1 MI? Is the novel Supertropo test able to separate exercise-induced troponin elevations from those caused by MI ? All participants provide written informed consent. The study complies with Declaration of Helsinki as revised in 2002 and the study protocol was approved by the Medical Ethics Committee of the Hospital District of Southwest Finland.

Statistical analysis Continuous variables are reported as mean ± standard deviation when normally distributed, and as median [inter-quartile range (IQR)] if they were skewed unless stated otherwise. The normality of the data distribution is examined by the Shapiro-Wilk test. Statistical significance was assumed at a p value < 0.05. Categorical variables were described with absolute and relative (percentage) frequencies. Chi-squared test and Fisher's exact test are used for categorical variables as appropriate. Independent samples t-test and Mann-Whitney U test are used for univariate analysis. Correlation between continuous variables are estimated using the Spearman test. Linear regression analysis with backward selection is used to identify factors significantly relating to post-race cTnT levels. All predictors with a P value < 0.1 in univariate analysis were included in the final regression model.

Study Type

Observational

Enrollment (Estimated)

170

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Finland
      • Turku, Finland, 20300
        • University of Turku

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

Yes

Sampling Method

Non-Probability Sample

Study Population

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

Description

Inclusion Criteria:

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

Exclusion Criteria:

-

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
marathon runners
Marathon runners
Diagnostic test: Troponin fragmentation
laboratory test from blood sample
myocardial infarction
Patients with Type 1 myocardial infarction
Diagnostic test: Troponin fragmentation
laboratory test from blood sample

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Magnitude of Troponin fragmentation in the post-race and post-MI (<24h) blood samples
Time Frame: < 1 hour after marathon race and < 24 hours after myocardial infarction
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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Turku

Collaborators

Turku University Hospital

Investigators

  • Principal Investigator: Juhani K Airaksinen, Md, PhD, Turku University Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

August 19, 2023

Primary Completion (Estimated)

September 1, 2024

Study Completion (Estimated)

September 1, 2024

Study Registration Dates

First Submitted

August 13, 2023

First Submitted That Met QC Criteria

August 18, 2023

First Posted (Actual)

August 21, 2023

Study Record Updates

Last Update Posted (Actual)

August 21, 2023

Last Update Submitted That Met QC Criteria

August 18, 2023

Last Verified

August 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 13.06.2023/207

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Myocardial Infarction

Clinical Trials on Troponin fragmentation

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Equatorial Guinea

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

3
Subscribe