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

NCT00658060 | Unknown

• 1 other identifier: SHEBA-07-4632-IE-CTIL
• Study Type: observational
• Target: 20
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Familial Mediterranean Fever

Keywords

FMF, Exertional leg pain

Outcome Measures

Primary Outcomes (1)

• change in spectroscopic appearance of muscle after exertion of muscle thigh

  1 hour

Secondary Outcomes (2)

• change in muscle intensity signal after exertion

  1 hour

• change in joint effusion status after exertion

  1 hour

Study Arms (2)

1

* 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

2

Control group * 1.Healthy subjects * 2.18-45 years old * 3.Non-smokers

Eligibility Criteria

• Age: 18 Years - 45 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)
• Sampling Method: Non-Probability Sample

Study Population

Patients with FMF, fulfilling the Tel Hashomer criteria for the diagnosis of FMF, suffering from episodes of exertional leg pain and or exertional ankle edema, 18-45 years old, on a stable (≥ 2 weeks) dose of oral colchicine therapy, Non-smokers

You may qualify if:

• Fulfilling the Tel Hashomer criteria for the diagnosis of FMF \[5\].
• Suffering from episodes of exertional leg pain and or exertional ankle edema
• years old
• On a stable (≥ 2 weeks) dose of oral colchicine therapy
• Non-smokers

You may not qualify if:

• with known peripheral vascular disease (PVD) and/or multiple risk factors for PVD (such as diabetes, hypertension, hyperlipidemia)
• Suffering from muscular or neurological diseases not related to FMF
• With elevated serum creatinine / liver enzymes/ creatine phosphokinase (CPK) levels.
• Suffering from claustrophobia, or with metal fragments in body tissue, or with other contraindications for MRI.

Sponsors & Collaborators

• Sheba Medical Center: lead

Study Sites (1)

Sheba Medical Center

Ramat Gan, 52621, Israel

RECRUITING

Related Publications (2)

• 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. doi: 10.1002/1529-0131(200106)44:63.0.CO;2-6.

  PMID: 11407703 BACKGROUND

• 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. doi: 10.1016/s0035-3787(06)75038-x. French.

  PMID: 16585908 BACKGROUND

MeSH Terms

Conditions

Familial Mediterranean Fever

Condition Hierarchy (Ancestors)

Hereditary Autoinflammatory Diseases; Genetic Diseases, Inborn; Congenital, Hereditary, and Neonatal Diseases and Abnormalities

Study Officials

• Iris Eshed, MD

  Sheba Medical Center

  PRINCIPAL INVESTIGATOR

• Tammi Kushnir, PhD

  Sheba Medical Center

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Merav Lidar, MD

CONTACT

+972-54-4721675; merav.lidar@sheba.health.gov.il

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: OTHER GOV

Study Record Dates

• First Submitted: April 8, 2008
• First Posted: April 14, 2008
• Study Start: September 1, 2007
• Last Updated: April 14, 2008

Record last verified: 2008-04

Locations

IL (1)