Ignite Creation Date:
2025-12-24 @ 4:06 PM
Ignite Modification Date:
2025-12-25 @ 2:07 PM
Study NCT ID:
NCT04349566
Status:
COMPLETED
Last Update Posted:
2022-10-27
First Post:
2020-04-14
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Fast Troponin as a Biomarker to Assess Exercise-induced Muscle Damage in Muscle Diseases
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D020388', 'term': 'Muscular Dystrophy, Duchenne'}, {'id': 'D006012', 'term': 'Glycogen Storage Disease Type V'}, {'id': 'C535895', 'term': 'Limb-girdle muscular dystrophy type 2A'}], 'ancestors': [{'id': 'D009136', 'term': 'Muscular Dystrophies'}, {'id': 'D020966', 'term': 'Muscular Disorders, Atrophic'}, {'id': 'D009135', 'term': 'Muscular Diseases'}, {'id': 'D009140', 'term': 'Musculoskeletal Diseases'}, {'id': 'D009468', 'term': 'Neuromuscular Diseases'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}, {'id': 'D040181', 'term': 'Genetic Diseases, X-Linked'}, {'id': 'D030342', 'term': 'Genetic Diseases, Inborn'}, {'id': 'D009358', 'term': 'Congenital, Hereditary, and Neonatal Diseases and Abnormalities'}, {'id': 'D006008', 'term': 'Glycogen Storage Disease'}, {'id': 'D002239', 'term': 'Carbohydrate Metabolism, Inborn Errors'}, {'id': 'D008661', 'term': 'Metabolism, Inborn Errors'}, {'id': 'D008659', 'term': 'Metabolic Diseases'}, {'id': 'D009750', 'term': 'Nutritional and Metabolic Diseases'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'CASE_CONTROL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 36}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2020-06-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2022-10', 'completionDateStruct': {'date': '2021-12-20', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2022-10-26', 'studyFirstSubmitDate': '2020-04-14', 'studyFirstSubmitQcDate': '2020-04-14', 'lastUpdatePostDateStruct': {'date': '2022-10-27', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2020-04-16', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2021-12-20', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Change in biomarkers', 'timeFrame': '24 hours', 'description': 'Change in Fast and slow Troponin I after muscle damage'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Becker Muscular Dystrophy', 'McArdle Disease', 'Limb-Girdle Muscular Dystrophy Type 2']}, 'descriptionModule': {'briefSummary': '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'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '50 Years', 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Patients with McArdle disease and patients with two sub-typesof Limb-girdle and Becker muscular dystrophies will be included as well as healthy controls.', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* The ability to cycle\n* No concurrent medical condition that could interfere with interpretation of the results\n* Molecular diagnosis of the specific condition in specified patient groups or healthy control\n* No active muscle injury on the test day (caused by recent exercise, seizures, trauma, etc.)\n\nExclusion Criteria:\n\n* Competing conditions at risk of compromising the results of the study\n* Cardiac or pulmonary disease contraindicating peak exercise testing or strenuous exercise\n* Veins that are too difficult to puncture for blood sampling, evaluated by the investigator\n* Severe muscle weakness, that prevents the subject completing the exercise test, evaluated by the investigator'}, 'identificationModule': {'nctId': 'NCT04349566', 'briefTitle': 'Fast Troponin as a Biomarker to Assess Exercise-induced Muscle Damage in Muscle Diseases', 'organization': {'class': 'OTHER', 'fullName': 'Rigshospitalet, Denmark'}, 'officialTitle': 'Fast Troponin as a Biomarker to Assess Exercise-induced Muscle Damage in Muscle Diseases', 'orgStudyIdInfo': {'id': 'FAST TROPONIN'}}, 'contactsLocationsModule': {'locations': [{'zip': 'DK-2100', 'city': 'Copenhagen', 'country': 'Denmark', 'facility': 'Neuromuscular Research Unit, 3342', 'geoPoint': {'lat': 55.67594, 'lon': 12.56553}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Mads Peter Godtfeldt Stemmerik', 'class': 'OTHER'}, 'collaborators': [{'name': 'Edgewise Therapeutics, Inc.', 'class': 'INDUSTRY'}], 'responsibleParty': {'type': 'SPONSOR_INVESTIGATOR', 'investigatorTitle': 'MD', 'investigatorFullName': 'Mads Peter Godtfeldt Stemmerik', 'investigatorAffiliation': 'Rigshospitalet, Denmark'}}}}