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Fast Troponin as a Biomarker to Assess Exercise-induced Muscle Damage in Muscle Diseases

Sponsor
Mads Peter Godtfeldt Stemmerik (Other)
Overall Status
Enrolling by invitation
CT.gov ID
NCT04349566
Collaborator
Edgewise Therapeutics, Inc. (Industry)
50
Enrollment
1
Location
22.9
Anticipated Duration (Months)
2.2
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

The purpose of the study is to explore the biomarker Fast Troponins response to exercise in patients with Becker muscular dystrophy, Limb-girdle muscular dystrophy and McArdle disease

Condition or Disease Intervention/Treatment Phase

    Study Design

    Study Type:
    Observational
    Anticipated Enrollment :
    50 participants
    Observational Model:
    Case-Control
    Time Perspective:
    Prospective
    Official Title:
    Fast Troponin as a Biomarker to Assess Exercise-induced Muscle Damage in Muscle Diseases
    Actual Study Start Date :
    Jun 1, 2020
    Anticipated Primary Completion Date :
    Apr 30, 2022
    Anticipated Study Completion Date :
    Apr 30, 2022

    Outcome Measures

    Primary Outcome Measures

    1. Change in biomarkers [24 hours]

      Change in Fast and slow Troponin I after muscle damage

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years to 50 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    Yes
    Inclusion Criteria:

    • The ability to cycle

    • No concurrent medical condition that could interfere with interpretation of the results

    • Molecular diagnosis of the specific condition in specified patient groups or healthy control

    • No active muscle injury on the test day (caused by recent exercise, seizures, trauma, etc.)

    Exclusion Criteria:

    • Competing conditions at risk of compromising the results of the study

    • Cardiac or pulmonary disease contraindicating peak exercise testing or strenuous exercise

    • Veins that are too difficult to puncture for blood sampling, evaluated by the investigator

    • Severe muscle weakness, that prevents the subject completing the exercise test, evaluated by the investigator

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Neuromuscular Research Unit, 3342 Copenhagen Denmark DK-2100

    Sponsors and Collaborators

    • Mads Peter Godtfeldt Stemmerik
    • Edgewise Therapeutics, Inc.

    Investigators

    None specified.

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Mads Peter Godtfeldt Stemmerik, MD, Rigshospitalet, Denmark
    ClinicalTrials.gov Identifier:
    NCT04349566
    Other Study ID Numbers:
    • FAST TROPONIN
    First Posted:
    Apr 16, 2020
    Last Update Posted:
    Dec 20, 2021
    Last Verified:
    Dec 1, 2021
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Additional relevant MeSH terms:
    Muscular Dystrophies
    Muscular Dystrophy, Duchenne
    Muscular Dystrophies, Limb-Girdle
    Glycogen Storage Disease Type V

    Study Results

    No Results Posted as of Dec 20, 2021