xml: <clinical_study>
    <!-- This xml conforms to an XML Schema at:
      https://clinicaltrials.gov/ct2/html/images/info/public.xsd -->
    <required_header>
      <download_date>ClinicalTrials.gov processed this data on September 20, 2023</download_date>
      <link_text>Link to the current ClinicalTrials.gov record.</link_text>
      <url>https://clinicaltrials.gov/ct2/show/NCT06000930</url>
    </required_header>
    <id_info>
      <org_study_id>13.06.2023/207</org_study_id>
      <nct_id>NCT06000930</nct_id>
    </id_info>
    <brief_title>Cardiac Troponin Fragmentation After Heavy Physical Exercise The MaraCat2 Study</brief_title>
    <acronym>MaraCat2</acronym>
    <official_title>Cardiac Troponin Fragmentation After Heavy Physical Exercise The MaraCat2 Study</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>University of Turku</agency>
        <agency_class>Other</agency_class>
      </lead_sponsor>
      <collaborator>
        <agency>Turku University Hospital</agency>
        <agency_class>Other</agency_class>
      </collaborator>
    </sponsors>
    <source>University of Turku</source>
    <oversight_info>
      <has_dmc>No</has_dmc>
      <is_fda_regulated_drug>No</is_fda_regulated_drug>
      <is_fda_regulated_device>No</is_fda_regulated_device>
    </oversight_info>
    <brief_summary>
      <textblock>
        Cardiac troponins are highly sensitive and specific biomarkers of cardiac injury and are in a&#xD;
        key role in the diagnosis of acute myocardial infarction (MI). Minor troponin elevations are&#xD;
        common after prolonged strenuous exercise without clinical symptoms of MI or myocardial&#xD;
        injury. Importantly, currently used high-sensitivity troponin T (cTnT) test detects also&#xD;
        smaller troponin fragments which may cause troponin elevation after exercise and lead to&#xD;
        false diagnosis of MI.&#xD;
  &#xD;
        In the present study protocol, we compare the characteristics troponin release after marathon&#xD;
        race and Type 1 MI with the improved version of our novel troponin fragmentation test&#xD;
        (SuperTropo test) and the commercial cTnT test.&#xD;
  &#xD;
        A total of 65 recreational runners participating in the 2023 Paavo Nurmi Marathon in Turku&#xD;
        are recruited. All participants give a blood sample during the post-race visit (within 30 min&#xD;
        after finishing the marathon).&#xD;
  &#xD;
        A control group of 90 patients with acute Type 1 MI are recruited among patients admitted to&#xD;
        Heart Centre of Turku University Hospital.&#xD;
  &#xD;
        Commercial cTnT and long troponin component of cTnT analyzed witha novel immunoassay are&#xD;
        dtermined in all subjects to assess cTnT fragmentation. TYhe main aims of the study are:&#xD;
  &#xD;
        To assess how often cTnT is elevated after marathon running and which factors affect the cTnT&#xD;
        rise? Is the fragmentation of troponin more common after marathon race compared with Type 1&#xD;
        MI and can the novel Supertropo test separate execise-induced troponin rise from those caused&#xD;
        by MI ?&#xD;
      </textblock>
    </brief_summary>
    <detailed_description>
      <textblock>
        Cardiac troponins are highly sensitive and specific biomarkers of cardiac injury and are in a&#xD;
        key role in the diagnosis of acute myocardial infarction (MI). Minor troponin elevations are&#xD;
        common after prolonged strenuous exercise without clinical symptoms of MI or myocardial&#xD;
        injury.&#xD;
  &#xD;
        Based on a small gel filtration chromatography study the released troponin in this condition&#xD;
        seems to be predominantly in the form of small fragments. These smaller cytosolic troponin&#xD;
        fragments may more easily traverse across cell membranes that have become leaky but not&#xD;
        irreversibly damaged. Importantly, currently used high-sensitivity troponin T (cTnT) test&#xD;
        detects also smaller troponin fragments which may lead to false diagnosis of MI.&#xD;
  &#xD;
        In a Proof-of-Principle study we developed a novel immunoassay which is much simpler and more&#xD;
        sensitive than previously used laboratory methods for studying cTnT fragmentation. In the&#xD;
        present study protocol, we compare the characteristics troponin release after marathon race&#xD;
        and Type 1 MI with the improved version of our novel troponin fragmentation test (SuperTropo&#xD;
        test) and the commercial cTnT test.&#xD;
  &#xD;
        A total of 65 recreational runners participating in the 2023 Paavo Nurmi Marathon in Turku&#xD;
        are recruited to the MaraCat2 Study with an open email invitation. All participants give a&#xD;
        blood sample during the post-race visit (within 60 min after finishing the marathon).&#xD;
  &#xD;
        A control group of 90 patients with acute Type 1 MI are recruited among patients admitted to&#xD;
        Heart Centre of Turku University Hospital. Coronary angiography is performed in all included&#xD;
        patients to confirm culprit lesion and the MI diagnosis. All included patients are treated&#xD;
        with primary or urgent percutaneous coronary intervention. Only patients with &lt;24 delay from&#xD;
        symptom onset to blood sample are included to avoid the effects of later gradual&#xD;
        fragmentation of cTnT in the circulation.&#xD;
  &#xD;
        Certified laboratory services by Turku University Hospital (TYKSLAB) take care of blood&#xD;
        samples. After centrifugation, serum is aliquoted, frozen and stored at -70 °C for later&#xD;
        analysis. Analysis is performed on a single day using the same calibration and set-up to&#xD;
        minimize variation.&#xD;
  &#xD;
        cTnT was analyzed using a commercial high-sensitive assay (Roche Diagnostics GmbH, Mannheim,&#xD;
        Germany).&#xD;
  &#xD;
        A novel sensitive time-resolved immunofluorometric assay is used for the detection of long&#xD;
        cTnT forms (long cTnT). The long cTnT assay follows the sandwich type immunoassay format and&#xD;
        utilizes time-resolved-fluorescence (TRF) as the measurement platform.&#xD;
  &#xD;
        The main aims of the study are:&#xD;
  &#xD;
        To assess how often cTnT is elevated after marathon running and which factors affect the cTnT&#xD;
        rise? Is the fragmentation of troponin complex (assessed by long cTnT/ total cTnT ratio) more&#xD;
        common after marathon race compared with Type 1 MI? Is the novel Supertropo test able to&#xD;
        separate exercise-induced troponin elevations from those caused by MI ? All participants&#xD;
        provide written informed consent. The study complies with Declaration of Helsinki as revised&#xD;
        in 2002 and the study protocol was approved by the Medical Ethics Committee of the Hospital&#xD;
        District of Southwest Finland.&#xD;
  &#xD;
        Statistical analysis Continuous variables are reported as mean ± standard deviation when&#xD;
        normally distributed, and as median [inter-quartile range (IQR)] if they were skewed unless&#xD;
        stated otherwise. The normality of the data distribution is examined by the Shapiro-Wilk&#xD;
        test. Statistical significance was assumed at a p value &lt; 0.05. Categorical variables were&#xD;
        described with absolute and relative (percentage) frequencies. Chi-squared test and Fisher's&#xD;
        exact test are used for categorical variables as appropriate. Independent samples t-test and&#xD;
        Mann-Whitney U test are used for univariate analysis. Correlation between continuous&#xD;
        variables are estimated using the Spearman test. Linear regression analysis with backward&#xD;
        selection is used to identify factors significantly relating to post-race cTnT levels. All&#xD;
        predictors with a P value &lt; 0.1 in univariate analysis were included in the final regression&#xD;
        model.&#xD;
      </textblock>
    </detailed_description>
    <overall_status>Enrolling by invitation</overall_status>
    <start_date type="Anticipated">August 19, 2023</start_date>
    <completion_date type="Anticipated">September 1, 2024</completion_date>
    <primary_completion_date type="Anticipated">September 1, 2024</primary_completion_date>
    <study_type>Observational</study_type>
    <has_expanded_access>No</has_expanded_access>
    <study_design_info>
      <observational_model>Cohort</observational_model>
      <time_perspective>Cross-Sectional</time_perspective>
    </study_design_info>
    <primary_outcome>
      <measure>Magnitude of Troponin fragmentation in the post-race and post-MI (&lt;24h) blood samples</measure>
      <time_frame>&lt; 1 hour after marathon race and &lt; 24 hours after myocardial infarction</time_frame>
      <description>Ratio of long troponin component to total troponin T in the post-race and post-MI (&lt;24h) blood sample</description>
    </primary_outcome>
    <number_of_groups>2</number_of_groups>
    <enrollment type="Anticipated">170</enrollment>
    <condition>Myocardial Infarction</condition>
    <condition>Myocardial Injury</condition>
    <arm_group>
      <arm_group_label>marathon runners</arm_group_label>
      <description>Marathon runners</description>
    </arm_group>
    <arm_group>
      <arm_group_label>myocardial infarction</arm_group_label>
      <description>Patients with Type 1 myocardial infarction</description>
    </arm_group>
    <intervention>
      <intervention_type>Diagnostic Test</intervention_type>
      <intervention_name>Troponin fragmentation</intervention_name>
      <description>laboratory test from blood sample</description>
      <arm_group_label>marathon runners</arm_group_label>
      <arm_group_label>myocardial infarction</arm_group_label>
    </intervention>
    <eligibility>
      <study_pop>
        <textblock>
          Marathon runners and patients with acute myocardial infarction as a control group&#xD;
        </textblock>
      </study_pop>
      <sampling_method>Non-Probability Sample</sampling_method>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
            -  participating marathon race or treated for Type 1 myocardial infarction and giving&#xD;
               informed consent&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
          -&#xD;
        </textblock>
      </criteria>
      <gender>All</gender>
      <minimum_age>18 Years</minimum_age>
      <maximum_age>80 Years</maximum_age>
      <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
    </eligibility>
    <overall_official>
      <last_name>Juhani K Airaksinen, Md, PhD</last_name>
      <role>Principal Investigator</role>
      <affiliation>Turku University Hospital</affiliation>
    </overall_official>
    <location>
      <facility>
        <name>University of Turku</name>
        <address>
          <city>Turku</city>
          <zip>20300</zip>
          <country>Finland</country>
        </address>
      </facility>
    </location>
    <location_countries>
      <country>Finland</country>
    </location_countries>
    <verification_date>August 2023</verification_date>
    <study_first_submitted>August 13, 2023</study_first_submitted>
    <study_first_submitted_qc>August 18, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">August 21, 2023</study_first_posted>
    <last_update_submitted>August 18, 2023</last_update_submitted>
    <last_update_submitted_qc>August 18, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">August 21, 2023</last_update_posted>
    <responsible_party>
      <responsible_party_type>Principal Investigator</responsible_party_type>
      <investigator_affiliation>University of Turku</investigator_affiliation>
      <investigator_full_name>Juhani Airaksinen</investigator_full_name>
      <investigator_title>Professor</investigator_title>
    </responsible_party>
    <keyword>exercise</keyword>
    <keyword>troponin</keyword>
    <keyword>myocardial infarction</keyword>
    <keyword>myocardial injury</keyword>
    <condition_browse>
      <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
      <mesh_term>Myocardial Infarction</mesh_term>
      <mesh_term>Infarction</mesh_term>
    </condition_browse>
    <patient_data>
      <sharing_ipd>Undecided</sharing_ipd>
    </patient_data>
    <!-- Results have not yet been posted for this study                                          -->
  </clinical_study>
  
  
text: download date: ClinicalTrials.gov processed this data on September 20, 2023
  link text: Link to the current ClinicalTrials.gov record.
  url: https://clinicaltrials.gov/ct2/show/NCT06000930
  org study id: 13.06.2023/207
  nct id: NCT06000930
  lead sponsor: 
  collaborator: 
  has dmc: No
  is fda regulated drug: No
  is fda regulated device: No
  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 ?
  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.
  observational model: Cohort
  time perspective: Cross-Sectional
  measure: 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
  description: Ratio of long troponin component to total troponin T in the post-race and post-MI (<24h) blood sample
  arm group label: marathon runners
  description: Marathon runners
  arm group label: myocardial infarction
  description: Patients with Type 1 myocardial infarction
  intervention type: Diagnostic Test
  intervention name: Troponin fragmentation
  description: laboratory test from blood sample
  arm group label: marathon runners
  arm group label: myocardial infarction
  study pop: 
  sampling method: Non-Probability Sample
  criteria: 
  gender: All
  minimum age: 18 Years
  maximum age: 80 Years
  healthy volunteers: Accepts Healthy Volunteers
  last name: Juhani K Airaksinen, Md, PhD
  role: Principal Investigator
  affiliation: Turku University Hospital
  facility: 
  country: Finland
  responsible party type: Principal Investigator
  investigator affiliation: University of Turku
  investigator full name: Juhani Airaksinen
  investigator title: Professor
  mesh term: Myocardial Infarction
  mesh term: Infarction
  sharing ipd: Undecided