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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified April 2008 by Sheba Medical Center.
Recruitment status was  Recruiting
Sponsor:
Information provided by:
Sheba Medical Center
ClinicalTrials.gov Identifier:
NCT00658060
First received: April 8, 2008
Last updated: April 11, 2008
Last verified: April 2008
  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

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Cross-Sectional
Official Title: Exertional Muscle Fatigue In FMF Patients Evaluated By MRI And MR Spectroscopy Of The Thigh

Resource links provided by NLM:


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 ]

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:

  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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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

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

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

ClinicalTrials.gov processed this record on July 20, 2014