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

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ClinicalTrials.gov Identifier: NCT00658060
Recruitment Status : Unknown
Verified April 2008 by Sheba Medical Center.
Recruitment status was:  Recruiting
First Posted : April 14, 2008
Last Update Posted : April 14, 2008
Sponsor:
Information provided by:
Sheba Medical Center

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.


Condition or disease
Familial Mediterranean Fever

Study Type : Observational
Estimated Enrollment : 20 participants
Observational Model: Cohort
Time Perspective: Cross-Sectional
Official Title: Exertional Muscle Fatigue In FMF Patients Evaluated By MRI And MR Spectroscopy Of The Thigh
Study Start Date : September 2007


Group/Cohort
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



Primary Outcome Measures :
  1. change in spectroscopic appearance of muscle after exertion of muscle thigh [ Time Frame: 1 hour ]

Secondary Outcome Measures :
  1. change in muscle intensity signal after exertion [ Time Frame: 1 hour ]
  2. change in joint effusion status after exertion [ Time Frame: 1 hour ]


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Ages Eligible for Study:   18 Years to 45 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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
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.

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): NCT00658060


Contacts
Contact: Merav Lidar, MD +972-54-4721675 merav.lidar@sheba.health.gov.il

Locations
Israel
Sheba Medical Center Recruiting
Ramat Gan, Israel, 52621
Contact: Iris Eshed         
Sponsors and Collaborators
Sheba Medical Center
Investigators
Principal Investigator: Iris Eshed, MD Sheba Medical Center
Principal Investigator: Tammi Kushnir, PhD Sheba Medical Center

Publications:
Responsible Party: Eshed Iris, MD, Sheba Medical Center
ClinicalTrials.gov Identifier: NCT00658060     History of Changes
Other Study ID Numbers: SHEBA-07-4632-IE-CTIL
First Posted: April 14, 2008    Key Record Dates
Last Update Posted: April 14, 2008
Last Verified: April 2008

Keywords provided by Sheba Medical Center:
FMF, Exertional leg pain

Additional relevant MeSH terms:
Familial Mediterranean Fever
Hereditary Autoinflammatory Diseases
Fever
Brucellosis
Body Temperature Changes
Signs and Symptoms
Gram-Negative Bacterial Infections
Bacterial Infections
Genetic Diseases, Inborn
Skin Diseases, Genetic
Skin Diseases