NCT03897803|Unknown
Elastography in Patients With Idiopathic Inflammatory Myopathies
Elastography as a Follow up Imaging Tool in Patients With Idiopathic Inflammatory Myopathies
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Elastography as a Follow up Imaging Tool in Patients With Idiopathic Inflammatory Myopathies
Sponsor study identifier
observational
80
1 country
1
Study Start
April 15, 2019
Actual (reported)Primary Completion
November 1, 2020
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
Study Completion
November 1, 2020
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
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.
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
November 1, 2020
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
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Some registry-reported names shown below are not yet linked in this graph.
Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
March 29, 2019
Actual (reported)April 1, 2019
Actual (reported)April 15, 2019
Actual (reported)November 1, 2020
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
November 1, 2020
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
Manual muscle testing
Kendall's 0 -10 point scale measures strength of each muscle group score 0 is the weakest (worst) and 10 is the strongest (best). The following muscles were tested bilaterally: the biceps brachii muscle (BB), the forearm flexors(FF), the rectus femoris muscle (RF), the tibialis anterior muscle (TA)
6 months
Serum creatine kinase (CK) levels
CK measured in U/L using ELISA
6 months
Serum Lactate dehydrogenase (LDH) levels
LDHmeasured in IU/L using ELISA
6 months
alanine aminotransferase (ALT)
ALT measured in U/L using ELISA
6 months
Aspartate aminotransferase (AST)
AST measured in U/L using ELISA
6 months
motor unit potential (MUP) duration
quantitative electromyography (QEMG) in the most affected rectus femoris and biceps brachii muscles will be performed and The motor unit potentials will be reviewed offline for the needle-detected EMG signals will be analyzed by the device software for the MUP duration measured in milliseconds.
6 months
motor unit peak-to-peak amplitude
quantitative electromyography (QEMG) in the most affected rectus femoris and biceps brachii muscles will be performed and The motor unit potentials will be reviewed offline for the needle-detected EMG signals will be analyzed by the device software for the peak-to-peak amplitude measured in microvolt
6 months
motor unit area to amplitude ratio (AAR)
quantitative electromyography (QEMG) in the most affected rectus femoris and biceps brachii muscles will be performed and The motor unit potentials will be reviewed offline for the needle-detected EMG signals will be analyzed by the device software for the motor unit AAR .
6 months
muscle echo intenisity (EI)
EI is assessed during muscle ultrasound evaluation means of computer-assisted grayscale histogram analysis of Adobe Photoshop . echo intensity was calculated based on a histogram analysis which expresses every pixel as a value between 0 (black) and 255 (white)..he following muscles were tested bilaterally: the biceps brachii muscle (BB), the forearm flexors(FF), the rectus femoris muscle (RF), the tibialis anterior muscle (TA)
6 MONTHS
Childhood myositis assessment scale
used to assess the severity of muscle involvement in children with dermatomyositis. The scores for the 14 items are summated to give a total score ranging from 0 (worst) to 52 (best)
6 months
MYOSITIS DISEASE ACTIVITY ASSESSMENT TOOL (MDAAT)
The MDAAT is a combined tool that includes the Myositis Disease Activity Assessment visual analog scale (VAS) (MYOACT) and the Myositis Intention to Treat Activities Index (MITAX).it Assesses 6 extramuscular organs to produce a global extramuscular score, and the muscle score, which gives a total disease activity index score. Scores range from 0-60 for the extramuscular MYOACT score and 0-70 for the total MYOACT score, and they range from 0-54 for the Extramuscular MITAX score and 0-63 for the total MITAX score. higher scores indicates worse outcome
6 months
CHILDHOOD HEALTH ASSESSMENT QUESTIONNAIRE (CHAQ)
There are 30 items in the Disability Index; one item each in the Discomfort Index and Health Status Index. Score range. The range is 0-3. Higher scores reflect greater disability.
6 months
HEALTH ASSESSMENT QUESTIONNAIRE (HAQ)
20 questions grouped into eight subscales (dressing and grooming, arising, eating, walking, hygiene, reach, grip, activities). (score = 0 to 3 with higher score means worse outcome ). The highest score for any question determines the score for the subscale in question. The HAQ disability index is calculated as the sum of the scores for various subscales,divided by the number of subscales responded to, and results in a score between 0 and 3. higher score means worse outcome
6months
MYOSITIS DAMAGE INDEX (MDI)
The MDI measures specific manifestations in 11 organ systems The MDI also includes a series of visual analog scales (VAS) to quantify damage severity in a given organ system. The VAS are summed together for a potential score of 0-110 with higher scores has worse prognosis
6months
PHYSICIAN GLOBAL ACTIVITY assessment
visual analogue scale rating, a score of 0-10 (down to 1 decimal place) is used, higher score means worse outcome
6 months
PATIENT/PARENT GLOBAL ACTIVITY assessment
visual analogue scale rating, a score of 0-10 (down to 1 decimal place) is used, higher score means worse outcome
6 months
Group (I): twenty children diagnosed to have juvenile dermatomyositis (JDM) Who will be evaluated using using strain elastography to assess muscle stiffness at baseline and after 4 months. .
Group (II): twenty adults diagnosed to have idiopathic inflammatory myopathies(IIM) Who will be evaluated using using strain elastography to assess muscle stiffness at baseline and after 4 months. * •
20 healthy children matching age and sex as first control group to children with JDM .Who will be evaluated at baseline using using strain elastography to assess muscle stiffness . .
20 healthy adults matching age and sex as second control group to adults with IIM. Who will be evaluated at baseline using using strain elastography to assess muscle stiffness .
strain elastography as apart of muscle ultrasound examination of the biceps brachii and rectus femoris muscles will be performed to the patients and control groups at baseline evaluation and after 4 months follow up in the patients groups only.
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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.
Benha University Hospital
Banhā, Qalyubia Governorate, 13518, Egypt
Waleed A Hassan, MD
Benha university- Qaluibya- Egypt
First Submitted
March 29, 2019
First Posted
April 1, 2019
Study Start
April 15, 2019
Actual (reported)Primary Completion
November 1, 2020
Estimated (date passed)JAK 1/2 Inhibitor, Baricitinib, in the Treatment of Adult IIM
Contact the study team to confirm eligibility.
This estimate has passed. The registry has not confirmed an actual date for this milestone.
Study Completion
November 1, 2020
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
Last Updated
October 19, 2020
Record last verified: 2020-10
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