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Elastography in Patients With Idiopathic Inflammatory Myopathies

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03897803
Recruitment Status : Recruiting
First Posted : April 1, 2019
Last Update Posted : January 6, 2020
Sponsor:
Information provided by (Responsible Party):
Waleed Ahmed Salaheldeen Hassan, Benha University

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.

Condition or disease Intervention/treatment
Idiopathic Inflammatory Myopathies Diagnostic Test: strain elastography

Detailed Description:

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):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 & 6-months follow up using Semi-Quantitative strain elastography

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Study Type : Observational
Estimated Enrollment : 120 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Elastography as a Follow up Imaging Tool in Patients With Idiopathic Inflammatory Myopathies
Actual Study Start Date : April 15, 2019
Estimated Primary Completion Date : June 15, 2020
Estimated Study Completion Date : June 15, 2020


Group/Cohort Intervention/treatment
Group (I):juvenile dermatomyositis (JDM)

Group (I): thirty children diagnosed to have juvenile dermatomyositis (JDM) Who will be evaluated using using strain elastography to assess muscle stiffness at baseline and after 6 months.

.

Diagnostic Test: strain elastography
strain elastography as apart of muscle ultrasound examination of the biceps brachii, forearm flexor, rectus femoris and tibialis anterior muscles will be performed to the patients and control groups at baseline evaluation and after 6 months follow up in the patients groups only.

Group (II):idiopathic inflammatory myopathies(IIM)

Group (II): thirty adults diagnosed to have idiopathic inflammatory myopathies(IIM) Who will be evaluated using using strain elastography to assess muscle stiffness at baseline and after 6 months.

Diagnostic Test: strain elastography
strain elastography as apart of muscle ultrasound examination of the biceps brachii, forearm flexor, rectus femoris and tibialis anterior muscles will be performed to the patients and control groups at baseline evaluation and after 6 months follow up in the patients groups only.

Group (III): juvenile control group

30 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 .

.

Diagnostic Test: strain elastography
strain elastography as apart of muscle ultrasound examination of the biceps brachii, forearm flexor, rectus femoris and tibialis anterior muscles will be performed to the patients and control groups at baseline evaluation and after 6 months follow up in the patients groups only.

Group (VI):adult control group
30 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 .
Diagnostic Test: strain elastography
strain elastography as apart of muscle ultrasound examination of the biceps brachii, forearm flexor, rectus femoris and tibialis anterior muscles will be performed to the patients and control groups at baseline evaluation and after 6 months follow up in the patients groups only.




Primary Outcome Measures :
  1. 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)

  2. Serum creatine kinase (CK) levels [ Time Frame: 6 months ]
    CK measured in U/L using ELISA

  3. Serum Lactate dehydrogenase (LDH) levels [ Time Frame: 6 months ]
    LDHmeasured in IU/L using ELISA

  4. alanine aminotransferase (ALT) [ Time Frame: 6 months ]
    ALT measured in U/L using ELISA

  5. Aspartate aminotransferase (AST) [ Time Frame: 6 months ]
    AST measured in U/L using ELISA

  6. 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.

  7. 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

  8. 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 .

  9. 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)

  10. 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)

  11. 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

  12. 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.

  13. 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

  14. 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

  15. 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

  16. 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



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   2 Years and older   (Child, Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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.
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03897803


Contacts
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Contact: Waleed Hassan, MD 01095000886 ext +2 waleed22101979@yahoo.com
Contact: Marwa Mahgoup, MD 01005530882 ext +2 marwayahiamlm@gmail.com

Locations
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Egypt
Benha University Hospital Recruiting
Banhā, Qalubiya, Egypt, 13518
Contact: Marwa Y Mahgoup, MD    01005530882 ext +2    marwayahiamlm@gmail.com   
Contact: Waleed Hassan, MD    00201095000886 ext +2    waleed22101979@yahoo.com   
Principal Investigator: Waleed A Hassan, MD         
Sub-Investigator: Marwa Y Mahgoup, MD         
Sub-Investigator: Shorouk Z Abdelshafy, MD         
Sponsors and Collaborators
Benha University
Investigators
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Principal Investigator: Waleed A Hassan, MD Benha university- Qaluibya- Egypt

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Responsible Party: Waleed Ahmed Salaheldeen Hassan, Assistant professor, Benha University
ClinicalTrials.gov Identifier: NCT03897803    
Other Study ID Numbers: BenhaU2022019
First Posted: April 1, 2019    Key Record Dates
Last Update Posted: January 6, 2020
Last Verified: July 2019

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Muscular Diseases
Myositis
Musculoskeletal Diseases
Neuromuscular Diseases
Nervous System Diseases