Magnetic Resonance (MR) Spectroscopy In Familial Mediterranean Fever (FMF) Patients

Familial Mediterranean Fever Clinical Trial

Official title:

Exertional Muscle Fatigue In FMF Patients Evaluated By MRI And MR Spectroscopy Of The Thigh

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT00658060
• Other study ID #: SHEBA-07-4632-IE-CTIL
• Status: Recruiting
• Phase: N/A
• First received: April 8, 2008
• Last updated: April 11, 2008
• Start date: September 2007

Study information

• Verified date: April 2008
• Source: Sheba Medical Center
• Contact: Merav Lidar, MD
• Phone: +972-54-4721675
• Email: merav.lidar[@]sheba.health.gov.il
• Is FDA regulated: No
• Health authority: Israel: Israeli Health Ministry Pharmaceutical Administration
• Study type: Observational

Clinical Trial Summary

Familial Mediterranean fever (FMF) is an inherited disorder of unknown etiology, characterized by recurrent episodes of fever, peritonitis and/or pleuritis.

Fever is the cardinal manifestation of FMF and is present in most attacks accompanied by abdominal pain.

Another clinical manifestation in patients with FMF is exertional muscle pain, usually in the thigh, which appears even after minor exercise or physical activity in young patients with generally good health (other than FMF) and in good physical condition. Some patients also complain of ankle edema after relatively minor physical activity, which subsides after a night rest. Although these manifestations are quite common in FMF patients and form part of the minor criteria for the diagnosis, the etiopathogenesis has not been examined.

The purpose of the suggested study is to evaluate and characterize the anatomical and biochemical changes in the muscles of the thigh and in the ankle triggered by physical activity in FMF patients complaining of exertional lower leg myalgias and edema after minor physical exercise.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 20
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years to 45 Years

Eligibility

Inclusion Criteria:

1. Fulfilling the Tel Hashomer criteria for the diagnosis of FMF [5].

2. Suffering from episodes of exertional leg pain and or exertional ankle edema

3. 18-45 years old

4. On a stable (= 2 weeks) dose of oral colchicine therapy

5. Non-smokers

Exclusion Criteria:

1. with known peripheral vascular disease (PVD) and/or multiple risk factors for PVD (such as diabetes, hypertension, hyperlipidemia)

2. Suffering from muscular or neurological diseases not related to FMF

3. With elevated serum creatinine / liver enzymes/ creatine phosphokinase (CPK) levels.

4. Suffering from claustrophobia, or with metal fragments in body tissue, or with other contraindications for MRI.

Study Design

Observational Model: Cohort, Time Perspective: Cross-Sectional

Related Conditions & MeSH terms

• Brucellosis
• Familial Mediterranean Fever
• Hereditary Autoinflammatory Diseases

Locations

Country	Name	City	State
Israel	Sheba Medical Center	Ramat Gan

Sponsors (1)

Lead Sponsor	Collaborator
Sheba Medical Center

Country where clinical trial is conducted

Israel, 

References & Publications (2)

Bendahan D, Mattei JP, Guis S, Kozak-Ribbens G, Cozzone PJ. [Non-invasive investigation of muscle function using 31P magnetic resonance spectroscopy and 1H MR imaging]. Rev Neurol (Paris). 2006 Apr;162(4):467-84. Review. French. — View Citation

Brik R, Shinawi M, Kasinetz L, Gershoni-Baruch R. The musculoskeletal manifestations of familial Mediterranean fever in children genetically diagnosed with the disease. Arthritis Rheum. 2001 Jun;44(6):1416-9. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	change in spectroscopic appearance of muscle after exertion of muscle thigh		1 hour	No
Secondary	change in muscle intensity signal after exertion		1 hour	No
Secondary	change in joint effusion status after exertion		1 hour	No