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

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Brief Title

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

Official Title

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

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.
    



Study Type

Observational


Primary Outcome

change in spectroscopic appearance of muscle after exertion of muscle thigh

Secondary Outcome

 change in muscle intensity signal after exertion

Condition

Familial Mediterranean Fever


Study Arms / Comparison Groups

 1
Description:  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

Publications

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information



Estimated Enrollment

20

Start Date

September 2007



Eligibility Criteria

        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.
      

Gender

All

Ages

18 Years - 45 Years

Accepts Healthy Volunteers

Accepts Healthy Volunteers

Contacts

Iris Eshed, MD, +972-54-4721675, [email protected]

Location Countries

Israel

Location Countries

Israel

Administrative Informations


NCT ID

NCT00658060

Organization ID

SHEBA-07-4632-IE-CTIL



Study Sponsor

Sheba Medical Center


Study Sponsor

Iris Eshed, MD, Principal Investigator, Sheba Medical Center


Verification Date

April 2008