Magnetic Resonance (MR) Spectroscopy In Familial Mediterranean Fever (FMF) Patients - Full Text View

Purpose

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

Familial Mediterranean Fever

Genetics Home Reference related topics:

familial Mediterranean fever

MedlinePlus related topics:

Fever

ChemIDplus related topics:

Brucellosis

U.S. FDA Resources

Study Type:	Observational
Study Design:	Cohort, Cross-Sectional

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

Further study details as provided by Sheba Medical Center:

Primary Outcome Measures:

change in spectroscopic appearance of muscle after exertion of muscle thigh [ Time Frame: 1 hour ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

change in muscle intensity signal after exertion [ Time Frame: 1 hour ] [ Designated as safety issue: No ]
change in joint effusion status after exertion [ Time Frame: 1 hour ] [ Designated as safety issue: No ]

Biospecimen Retention: None Retained

Biospecimen Description:

Estimated Enrollment:	20
Study Start Date:	September 2007

Groups/Cohorts

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

Ages Eligible for Study:	18 Years to 45 Years
Genders Eligible for Study:	Both
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:

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

Exclusion Criteria:

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.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: 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

More Information

Publications:

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.

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.

Responsible Party:	Sheba Medical Center ( Eshed Iris, MD )
Study ID Numbers:	SHEBA-07-4632-IE-CTIL
First Received:	April 8, 2008
Last Updated:	April 11, 2008
ClinicalTrials.gov Identifier:	NCT00658060
Health Authority:	Israel: Israeli Health Ministry Pharmaceutical Administration