An observational study in Myositis and Muscular Disorders, Atrophic, sponsored by University of Warwick. Status unknown at 3 sites in United Kingdom. Open to participants aged 18 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2012-10-18.
Sponsored by University of Warwick · Observational
A prospective observational study to determine the effectiveness of magnetic resonance (MR) imaging in the diagnosis and monitoring of idiopathic myopathy in adult humans.
Idiopathic inflammatory myopathies are a heterogeneous group of conditions characterised by skeletal muscle inflammation leading to proximal muscle weakness, often with tenderness, and occasionally dermatological manifestations. Diagnosis is clinical and is based on the Bohan and Peter criteria which comprises clinical examination, serological markers, electromyography (EMG) and muscle biopsy. This has relatively poor sensitivity and specificity. Muscle biopsy in particular has a false negative rate of 10-15% and is invasive. Clinical criteria also lack the discriminatory power to differentiate between recurrent (or breakthrough) myopathy and myopathy secondary to treatment with corticosteroid.
Magnetic resonance (MR) imaging has the advantage of being non-invasive, and is able to discriminate between different tissues, and to identify areas of inflammation. The aim of this study is to assess the effectiveness of MR sequences in the diagnosis of myopathy, monitoring of treatment response, and in differentiating between breakthrough myopathy and steroid-induced myopathy.
242 studies on the registry are indexed under Myositis; 103 are open to participants now.
This study's planned enrollment of 70 is below the median of 226 across 72 observational studies indexed under Myositis.
Browse Myositis studies →University of Warwick is the lead sponsor of 26 studies on the registry; 3 are open to participants now.
Counted across the registry records on this site, refreshed daily.
The study group will be patients attendeing rheumatology outpoatient clinics with a suspected diagnosis of myopathy based on clinical criteria
Exclusion Criteria:
Participants with suspected myositis based on clinical criteria (Bohan and Peters criteria) referred for Magnetic resonance imaging
Procedure: Magnetic Resonance Imaging
Normal volunteers without myositis, who will undergo MR imaging to establish normal ranges of MR signal in health muscle
Procedure: Magnetic Resonance Imaging
Also known as: Magnetic Resonance Imaging of the thighs
MR signal (T1w, T2w and STIR sequences) in muscle.
The correlation between MR signal and the clinical criteria will be measured
Time frame: 2 years
Correlation between MR appearances (T1w, T2w and STIR signal on MR)and the symptom severity (Bohan and Peter criteria)
Time frame: 2 years
Difference in MR signal between myopathy and steroid-induced myopathy, with sensitivity and specificity
Time frame: 2 years
Sensitivity and specificity of MR against the gold standard of clinical criteria
The MR signal will be compared against the Bohan and Peters criteria (the current gold standard) to determine sensitivity and specificity of the technique
Time frame: 2 years
This study is status unknown, as verified in Oct 2012. You cannot join it, but the record below documents what was studied.
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University of Warwick