Idiopathic Inflammatory MyopathiesNCT03897803
Elastography in Patients With Idiopathic Inflammatory Myopathies
An observational study of Idiopathic Inflammatory Myopathies, run by Benha University at 1 site in Egypt.
Trial 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. Read more about this study
- Who is it for?
- Ages 2 years and olderHealthy volunteers can take part
- Conditions the study is for
- Idiopathic Inflammatory Myopathies
- What is being tested?
- strain elastography
- How many people
- 80 participants
- Where
- 1 siteEgypt
- Study dates
- 15 Apr 2019to 1 Nov 2020
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 2 years and older
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
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.
Who may be able to join
- to fulfill criteria of diagnosis of childhood and adult idiopathic inflammatory myopathies
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
Egypt1 site, 1 recruiting
- Recruiting
Benha University Hospital
Banhā, Qalyubia Governorate, 13518
Marwa Y Mahgoup, MD, 01005530882 ext. +2, marwayahiamlm@gmail.com
Waleed Hassan, MD, 00201095000886 ext. +2, waleed22101979@yahoo.com
About this study
Official title: Elastography as a Follow up Imaging Tool in Patients With Idiopathic Inflammatory Myopathies
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.
Read the 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
- Conditions
- Idiopathic Inflammatory Myopathies
- Being tested
- strain elastography
- Medical subject headings
- Myositis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
strain elastographyDiagnostic test
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.
| Study group | Role | What they receive |
|---|---|---|
| Group (I):juvenile dermatomyositis (JDM) | 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.
. Receives: Diagnostic Test: strain elastography | |
| Group (II):idiopathic inflammatory myopathies(IIM) | 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.
* • Receives: Diagnostic Test: strain elastography | |
| Group (III): juvenile control group | 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 .
. Receives: Diagnostic Test: strain elastography | |
| Group (VI):adult control group | 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 . Receives: Diagnostic Test: strain elastography |
What is being measured
The primary outcome is the main question the study is designed to answer.
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)
Measured: 6 months
Serum creatine kinase (CK) levels
CK measured in U/L using ELISA
Measured: 6 months
Serum Lactate dehydrogenase (LDH) levels
LDHmeasured in IU/L using ELISA
Measured: 6 months
alanine aminotransferase (ALT)
ALT measured in U/L using ELISA
Measured: 6 months
Aspartate aminotransferase (AST)
AST measured in U/L using ELISA
Measured: 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.
Measured: 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
Measured: 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 .
Measured: 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)
Measured: 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)
Measured: 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
Measured: 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.
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Apr 2019
- Study start15 Apr 2019
- Primary completion1 Nov 2020 (estimated)
- Study completion1 Nov 2020 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Idiopathic Inflammatory MyopathiesStudies of the same condition, open and under way.
- More trials run by Benha UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 80 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Benha University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Waleed Ahmed Salaheldeen Hassan, Benha University
- Investigators
- Waleed A Hassan, MD, Principal investigator, Benha university- Qaluibya- Egypt
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03897803
- Sponsor's protocol ID
- BenhaU2022019
- Status last verified
- Oct 2020
- First submitted
- 29 Mar 2019
- Last updated
- 19 Oct 2020
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Oct 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Elastography as a Follow up Imaging Tool in Patients With Idiopathic Inflammatory Myopathies
- ClinicalTrials.gov ID
- NCT03897803
- Acronym / sponsor ID
- BenhaU2022019
- Conditions
- Idiopathic Inflammatory Myopathies
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 80 participants (estimated)
- Lead sponsor
- Benha UniversityUniversity, hospital or other
- Study start
- 15 Apr 2019 (actual)
- Primary completion
- 1 Nov 2020 (estimated)
- Study completion
- 1 Nov 2020 (estimated)
- First posted
- 1 Apr 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Group (I):juvenile dermatomyositis (JDM) | – | Diagnostic Test: strain elastographyGroup (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):idiopathic inflammatory myopathies(IIM) | – | Diagnostic Test: strain elastographyGroup (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. * • |
| Group (III): juvenile control group | – | Diagnostic Test: strain elastography20 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 . . |
| Group (VI):adult control group | – | Diagnostic Test: strain elastography20 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 . |
Who may qualify
- Ages
- 2 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
- 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.
Key inclusion criteria (1 listed)
- to fulfill criteria of diagnosis of childhood and adult idiopathic inflammatory myopathies
Key exclusion criteria (2 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| strain elastographystrain 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. | Diagnostic test | Group (I):juvenile dermatomyositis (JDM), Group (II):idiopathic inflammatory myopathies(IIM), Group (III): juvenile control group, Group (VI):adult control group |
Primary outcome
Manual muscle testing
Time frame: 6 months
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)
Serum creatine kinase (CK) levels
Time frame: 6 months
CK measured in U/L using ELISA
Serum Lactate dehydrogenase (LDH) levels
Time frame: 6 months
LDHmeasured in IU/L using ELISA
alanine aminotransferase (ALT)
Time frame: 6 months
ALT measured in U/L using ELISA
Aspartate aminotransferase (AST)
Time frame: 6 months
AST measured in U/L using ELISA
motor unit potential (MUP) duration
Time frame: 6 months
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.
motor unit peak-to-peak amplitude
Time frame: 6 months
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
motor unit area to amplitude ratio (AAR)
Time frame: 6 months
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 .
muscle echo intenisity (EI)
Time frame: 6 MONTHS
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)
Childhood myositis assessment scale
Time frame: 6 months
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)
MYOSITIS DISEASE ACTIVITY ASSESSMENT TOOL (MDAAT)
Time frame: 6 months
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
CHILDHOOD HEALTH ASSESSMENT QUESTIONNAIRE (CHAQ)
Time frame: 6 months
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.
HEALTH ASSESSMENT QUESTIONNAIRE (HAQ)
Time frame: 6months
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
MYOSITIS DAMAGE INDEX (MDI)
Time frame: 6months
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
PHYSICIAN GLOBAL ACTIVITY assessment
Time frame: 6 months
visual analogue scale rating, a score of 0-10 (down to 1 decimal place) is used, higher score means worse outcome
PATIENT/PARENT GLOBAL ACTIVITY assessment
Time frame: 6 months
visual analogue scale rating, a score of 0-10 (down to 1 decimal place) is used, higher score means worse outcome
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Oct 2020.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Waleed A Hassan, MD principal investigator
Benha university- Qaluibya- Egypt
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Idiopathic Inflammatory Myopathies, run by Benha University at 1 site in Egypt.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 19 Oct 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Waleed Hassan, MD (01095000886 ext. +2, waleed22101979@yahoo.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Manual muscle testing (time frame: 6 months). The study lists 16 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Oct 2020.