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Main
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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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ClinicalTrials.gov |
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Last refreshed on:
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12 December 2020 |
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Main ID: |
NCT03018184 |
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Date of registration:
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10/01/2017 |
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Prospective Registration:
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No |
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Primary sponsor: |
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Public title:
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Contractile Cross Sectional Areas and Muscle Strength in Patients With Congenital Myopathies
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Scientific title:
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Contractile Cross Sectional Areas and Muscle Strength in Patients With Congenital Myopathies Compared to Healthy Controls |
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Date of first enrolment:
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December 2016 |
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Target sample size:
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200 |
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Recruitment status: |
Active, not recruiting |
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URL:
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https://clinicaltrials.gov/show/NCT03018184 |
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Study type:
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Observational |
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Study design:
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Phase:
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Countries of recruitment
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Denmark
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Contacts
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Name:
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John Vissing, MD DMSc |
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Address:
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Telephone:
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Email:
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Affiliation:
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Copenhagen Neuromuscular Center, Rigshospitalet |
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Key inclusion & exclusion criteria
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Inclusion Criteria:
- Verified inherited muscle disease.
- Age: Over 18 years old
Exclusion Criteria:
- Contraindications for an MRI.
- Claustrophobia.
- Pregnant or nursing women.
- Competing disorders (as arthritis) or other muscle disorders.
Age minimum:
18 Years
Age maximum:
80 Years
Gender:
All
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Health Condition(s) or Problem(s) studied
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Inherited Muscle Diseases
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RYR1-myopathy
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Congenital Myopathy
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Intervention(s)
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Other: MRI and Muscle Dynamometer
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Primary Outcome(s)
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Muscle CCSA, investigated by Dixon MRI techniques.
[Time Frame: MRI scan per subject lasts approximately 60 minutes.]
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Muscle strength, measured as peak torque, investigated by an isokinetic dynamometer (Biodex 4).
[Time Frame: The tests takes less than an hour per subject.]
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Secondary Outcome(s)
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Muscle Strength, MRC
[Time Frame: The exam lasts less than 15 min per subject.]
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Secondary ID(s)
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H-16045346
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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Results
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Results available:
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Date Posted:
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Date Completed:
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URL:
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