To construct an optimal diagnostic algorithm with the best possible accuracy, and the least patient burden, for patients suspected for idiopathic inflammatory myopathy who need treatment with corticosteroids.
ID
Source
Brief title
Condition
- Neuromuscular disorders
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
Diagnostic accuracy of various strategies, taking patient burden into account.
Secondary outcome
Costs of diagnostic tests in the respective testing strategies.
Background summary
Idiopathic inflammatory myopathies (IIMs) are a heterogeneous group of
immune-related diseases, that need to be treated with prednisone (with the
exception of sIBM). Because of heterogeneity, patients present with a range of
clinical features, which makes it often hard to diagnose patients with this
disease. Several diagnostic guidelines exist, and many diagnostic tools are
recommended for diagnosis, although gold standard does not exist.
The full panel of diagnostic tools includes, beside clinical history, anamnesis
and plane laboratory tests (including sCK), electromyography (EMG),
muscle-ultrasound (US), MRI, (MRI guided) muscle biopsy and determination of
antibodies.
We hypothesize that an evidence based diagnostic algorithm, using fewer and
preferably the least invasive diagnostic modalities can approach the accuracy
of the complete panel of diagnostic tests.
Study objective
To construct an optimal diagnostic algorithm with the best possible accuracy,
and the least patient burden, for patients suspected for idiopathic
inflammatory myopathy who need treatment with corticosteroids.
Study design
Prospective, fully paired diagnostic accuracy study, with a complete diagnostic
protocol for patients suspected of having idiopathic inflammatory myopathy with
an indication for corticosteroid therapy.
Study burden and risks
Patients will be admitted to the neurology department for maximum 1.5 day. This
will be out of patient care, so they don't neet to travel to the hospital five
times, for five separate diagnostic tests. Thereby, diagnosis can be given at
the end of these 1.5 dat, and patients can start treatment earlier.
The panel of diagnostic tests is equal to the normal diagnostic tests, with
some variation between the Dutch hospitals. The risk of the diagnostic thest is
equal to these test out of study context. The EMG is an unpleasant test, and
takes about 30 minutes of time. Muscle ultrasound is a non-invasive diagnostic
test. MRI is a safe radiologic test, the protocol takes about 30-45 minutes of
time. The muscle biopsy is an invasive, sometimes painfull, but short
intervention. It will be perfomed under local anesthesia. Risks of the muscle
biopsy consist of infection and bleeding, but they rarely occur. Antibodies
will be tested after venipuncture, 150uL is needed for the analysis.
Meibergdreef 9
Amsterdam 1105 AZ
NL
Meibergdreef 9
Amsterdam 1105 AZ
NL
Listed location countries
Age
Inclusion criteria
In order to be eligible to participate in this study, a patient must be adult
(>=18 years of age) and suspected of an idiopathic inflammatory myopathy based
on signs and symptoms. The latter include:
• Symmetrical proximal muscle weakness causing functional limitation to justify
treatment with corticosteroids, without significant sensory abnormalities.
• Start of symptoms <=24 months
Exclusion criteria
• Other clear cause for proximal muscle weakness, i.e. the use of myotoxic
medication, high suspicion for an inflammatory neuropathy (CIDP) or a positive
family history for a hereditary neuromuscular disease
• A high suspicion for sporadic inclusion body myositis (sIBM) based on
clinical symptoms, including: combination of slow onset of asymmetrically,
predominantly distal weakness, atrophy of quadriceps and forearms and age >50
years.3
• High suspicion on a neurogenic cause, based on more severe distal weakness
than proximal weakness, asymmetric weakness, fasciculations in >1 region
• No availability for follow-up of 6 months
• Immunosuppressive treatment
• Previous history of myositis
• Contraindications for MRI, claustrophobia
• No consent for muscle biopsy
Design
Recruitment
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
In other registers
| Register | ID |
|---|---|
| CCMO | NL72219.018.19 |