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

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Статус

Спонзори

Sheba Medical Center

КЛИНИЧКО ИСПИТУВАЊЕ: NCT00658060

BioSeek: nct00658060

Клучни зборови

фамилијарна медитеранска треска

Апстракт

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.

Датуми

Последен пат проверено:	03/31/2008
Прво доставено:	04/07/2008
Поднесено е проценето запишување:	04/10/2008
Прво објавено:	04/13/2008
Последното ажурирање е доставено:	04/10/2008
Последно ажурирање објавено:	04/13/2008
Крај на датумот на започнување на студијата:	08/31/2007

Состојба или болест

Familial Mediterranean Fever

Фаза

Групи за раце

Рака	Интервенција / третман
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

Критериуми за подобност

Возраст подобни за студии	18 Years До 18 Years
Полови квалификувани за студии	All
Метод на земање примероци	Non-Probability Sample
Прифаќа здрави волонтери	Да
Критериуми	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.

Исход

Мерки на примарниот исход

1. change in spectroscopic appearance of muscle after exertion of muscle thigh [1 hour]

Секундарни мерки на исходот

1. change in muscle intensity signal after exertion [1 hour]

2. change in joint effusion status after exertion [1 hour]

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

Клучни зборови

бруцелоза

peritonitis

pleurisy

abdominal pain

треска

edema

миалгија