Ignite Creation Date:
2024-05-05 @ 11:20 AM
Last Modification Date:
2024-10-26 @ 9:02 AM
Study NCT ID:
NCT00001265
Status:
COMPLETED
Last Update Posted:
2024-04-17
First Post:
1999-11-03
Brief Title:
Study and Treatment of Inflammatory Muscle Diseases
Sponsor:
National Institute of Arthritis and Musculoskeletal and Skin Diseases NIAMS
Organization:
National Institutes of Health Clinical Center CC
Study Overview
Official Title:
Studies on the Natural History and Pathogenesis of Polymyositis Dermatomyositis and Related Diseases
Status:
COMPLETED
Status Verified Date:
2024-04
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
This study of inflammatory muscle diseases-polymyositis and dermatomyositis and related disorders-will examine what causes these diseases and describe the clinical features signs and symptoms associated with them Inflammation and degeneration of skeletal muscles in these disorders leads to weakness and muscle wasting The skin lungs and other organs may also be involved
Patients 16 years of age and older with polymyositis dermatomyositis or a related disorder may be eligible for this study Participants will undergo a complete history and physical examination including routine blood and urine tests Additional procedures for diagnosis treatment or research may include
1 Blood sample for genetic studies
2 Muscle biopsy-removal of a tissue sample for microscopic examination Under local anesthetic a 12- to 1-inch long incision is made in the thigh or upper arm and a small piece of muscle is removed
3 Electromyography-measurement of the electrical activity of a muscle A needle is inserted through the skin into a muscle to record its electrical activity
4 Magnetic resonance imaging-visualization of organs or tissues using a magnetic field and radio waves The patient lies on a table inside a narrow cylinder the MRI scanner with a strong magnetic field for the scanning
5 Manual muscle strength testing by a physiotherapist
6 Swallowing studies using ultrasound imaging using sound waves and X-rays barium swallow to evaluate swallowing and speaking abilities
7 Questionnaires on swallowing ability and ability to perform daily living activities
8 Pulmonary function tests-measurement of movement of air in and out of the lungs The patient breathes into a machine to evaluate lung function
9 Chest X-rays to evaluate lung function
10 Electrocardiogram and if necessary Holter monitoring measurement of the electrical activity of the heart and echocardiogram ultrasound imaging of the heart to evaluate heart function
11 Apheresis-collection of white blood cells for research Whole blood is collected through a needle placed in an arm vein The blood circulates through a machine that separates it into its components The white cells are removed and the rest of the blood is returned to the body through the same needle or through a second one placed in the other arm
12 MR guided muscle biopsy-measurement of glycogen in muscle tissue using magnetic resonance imaging Certain patients may undergo this experimental procedure to compare MRI findings with those of muscle biopsy The affected muscles are identified using MRI and the biopsy incision is made MRI is then used to guide the biopsy needle to the muscle and a small piece is removed
Patients who are eligible for experimental treatment studies will be offered the opportunity to join them Others will be advised of treatment recommendations
Patients 16 years of age and older with polymyositis dermatomyositis or a related disorder may be eligible for this study Participants will undergo a complete history and physical examination including routine blood and urine tests Additional procedures for diagnosis treatment or research may include
1 Blood sample for genetic studies
2 Muscle biopsy-removal of a tissue sample for microscopic examination Under local anesthetic a 12- to 1-inch long incision is made in the thigh or upper arm and a small piece of muscle is removed
3 Electromyography-measurement of the electrical activity of a muscle A needle is inserted through the skin into a muscle to record its electrical activity
4 Magnetic resonance imaging-visualization of organs or tissues using a magnetic field and radio waves The patient lies on a table inside a narrow cylinder the MRI scanner with a strong magnetic field for the scanning
5 Manual muscle strength testing by a physiotherapist
6 Swallowing studies using ultrasound imaging using sound waves and X-rays barium swallow to evaluate swallowing and speaking abilities
7 Questionnaires on swallowing ability and ability to perform daily living activities
8 Pulmonary function tests-measurement of movement of air in and out of the lungs The patient breathes into a machine to evaluate lung function
9 Chest X-rays to evaluate lung function
10 Electrocardiogram and if necessary Holter monitoring measurement of the electrical activity of the heart and echocardiogram ultrasound imaging of the heart to evaluate heart function
11 Apheresis-collection of white blood cells for research Whole blood is collected through a needle placed in an arm vein The blood circulates through a machine that separates it into its components The white cells are removed and the rest of the blood is returned to the body through the same needle or through a second one placed in the other arm
12 MR guided muscle biopsy-measurement of glycogen in muscle tissue using magnetic resonance imaging Certain patients may undergo this experimental procedure to compare MRI findings with those of muscle biopsy The affected muscles are identified using MRI and the biopsy incision is made MRI is then used to guide the biopsy needle to the muscle and a small piece is removed
Patients who are eligible for experimental treatment studies will be offered the opportunity to join them Others will be advised of treatment recommendations
Detailed Description:
Polymyositis dermatomyositis and related disorders also known as the idiopathic inflammatory myopathies IIM are an uncommon heterogeneous group of diseases This is an omnibus protocol designed to continue our description of this rare group of diseases further delineate important groups of patients and obtain useful material for further study of immunological abnormalities pathogenesis and etiology of IIM Often the diagnosis of an IIM can be confused with other illness such as adult-onset dystrophies and therefore we will be evaluating patients with other illnesses who are referred with a preliminary diagnosis of an IIM 1 Patients evaluated with IIM will receive with informed consent the best standard therapies available and consideration for entry into any therapeutic protocols MRI will be performed on healthy volunteers to help develop a mathematical method for quantitating edema of muscle MRI in patients 2 MRIPET will be performed on some patients and on healthy volunteers to evaluate its role in understanding muscle disease
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| 91-AR-0196 | None | None | None |