Clinical trial NCT03897803: Elastography in Patients With Idiopathic Inflammatory Myopathies
Official title: Elastography as a Follow up Imaging Tool in Patients With Idiopathic Inflammatory Myopathies
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Idiopathic Inflammatory Myopathies
Lead sponsor: Benha University
Sponsor class: OTHER
First posted: 2019-04-01
Enrollment: 80
Sex: ALL
Minimum age (years): 2
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: This study will be carried out on four groups:

Group (I): thirty children diagnosed to have idiopathic inflammatory myopathies(IIM)

* Group (II): thirty adults diagnosed to have IIM
* Group (III):30 healthy children matching age and sex as first control group to children with IIM .
* Group (VI):30 healthy adults matching age and sex as second control group to adults with IIM.

Brief summary: The aim of our study was to assess the performance of compression-strain US elastography in patients with idiopathic inflammatory myopathies over time and to study these findings with clinical and functional parameters as well as biochemical and electromyographic tests.

Detailed description: This study will be carried out on four groups:

Group (I): twenty children diagnosed to have idiopathic inflammatory myopathies(IIM)

* Group (II): twenty adults diagnosed to have IIM
* Group (III):20 healthy children matching age and sex as first control group to children with IIM .
* Group (VI):20 healthy adults matching age and sex as second control group to adults with IIM.

All patients will be evaluated at baseline at \& 4-months follow up using Semi-Quantitative strain elastography

Eligibility criteria: Inclusion Criteria:

* to fulfill criteria of diagnosis of childhood and adult idiopathic inflammatory myopathies

Exclusion Criteria:

* Patients with age less than 2 years were excluded from the study due to inability to perform manual muscle testing and functional scales.
* The presence of a associated illness that may result in nerve or muscle affection

Primary outcomes:
measure: Manual muscle testing
timeFrame: 6 months
measure: Serum creatine kinase (CK) levels
timeFrame: 6 months
measure: Serum Lactate dehydrogenase (LDH) levels
timeFrame: 6 months
measure: alanine aminotransferase (ALT)
timeFrame: 6 months
measure: Aspartate aminotransferase (AST)
timeFrame: 6 months
measure: motor unit potential (MUP) duration
timeFrame: 6 months
measure: motor unit peak-to-peak amplitude
timeFrame: 6 months
measure: motor unit area to amplitude ratio (AAR)
timeFrame: 6 months
measure: muscle echo intenisity (EI)
timeFrame: 6 MONTHS
measure: Childhood myositis assessment scale
timeFrame: 6 months
measure: MYOSITIS DISEASE ACTIVITY ASSESSMENT TOOL (MDAAT)
timeFrame: 6 months
measure: CHILDHOOD HEALTH ASSESSMENT QUESTIONNAIRE (CHAQ)
timeFrame: 6 months
measure: HEALTH ASSESSMENT QUESTIONNAIRE (HAQ)
timeFrame: 6months
measure: MYOSITIS DAMAGE INDEX (MDI)
timeFrame: 6months
measure: PHYSICIAN GLOBAL ACTIVITY assessment
timeFrame: 6 months
measure: PATIENT/PARENT GLOBAL ACTIVITY assessment
timeFrame: 6 months
Secondary outcomes:
Other outcomes:
Locations:
city: Banhā
country: Egypt
facility: Benha University Hospital
state: Qalubiya
Study officials:
affiliation: Benha university- Qaluibya- Egypt
name: Waleed A Hassan, MD
role: PRINCIPAL_INVESTIGATOR
References: