Retrospective Study That Evaluate the Effect of HCG Treatment as a Cardiovascular Disease Morbidity Factor in Patients With Primary Sjogren Syndrome
试验速览
- 阶段
- 不适用
- 入组人数
- 500
- 主要终点
- Arterial cardiovascular events
研究概览
简要总结
sjogren syndrome is an autoimmune disease that mainly affects the Salivary glands and Lacrimal gland In addition to the effects of this disease is characterized by overall systemic Muskals injury, pulmonary disease, peripheral neuropathy and vasculitis. In addition recent studies have shown that patients are at increased risk of the disease up to 2 cardiac events and stroke events Hydroxychloroquine is an RHEUMATIC DISEASE PROCESS SUPPRESSANTS-ANTIMALARIALS used to treat anti-inflammatory rheumatic diseases in many first-line treatment is sjogren syndrome.
A recent study of the treatment in Hydroxychloroquine effect on lipid profile sjogren syndrome patients showed a reduction in total cholesterol levels and increase in HDL. Further studies of the impact made Hydroxychloroquine systemic lupus patients erythematosus (SLE) showed in Atherosclerosis and morbidity and mortality reduction in cardiovascular. Studies of patients with rheumatoid arthritis (RA) demonstrated reduced risk of developing diabetes and improved lipid profile Research Goals valuate The effect of HCQ treatment in cardiovascular patients with primary sjogren syndrome
详细描述
Research Goals Valuate The effect of HCQ treatment in cardiovascular patients with primary sjogren syndrome Research Methods The study will included patients that diagnosed with sjogren syndrome and was treated in Meir Medical center during the years 2003-2014 During the study will collect information on confounding factors , Risk factors include cardiovascular acceptable such as diabetes, dyslipidemia, high blood pressure and the like, central nervous system involvement and steroid use
Study outcome will be one of the follow:
-
Thrombosis of peripheral veins
-
Arterial cardiovascular events
-
Cardiac events (myocardial infarction
-
Stroke (stroke and TIA)
-
Venous thrombosis events 5. Pulmonary embolism In the study will be 500 patients
Inclusion criteria:
研究设计
- 研究类型
- Observational
- 观察模型
- Case Only
- 时间视角
- Retrospective
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •18 years old
- •Patients that diagnosis in sjogren in treated in Meir Medical center in the years 2003-2014 And treated in Hydroxychloroquine at least a month.
排除标准
- •Minors and special populations
- •Patients that treated in Hydroxychloroquine at less than a month.
- •Patient that participate in clinical trial and treat with investigational product
结局指标
主要结局
Arterial cardiovascular events
时间窗: 15 years since the first dose of hydroxychloroquine
次要结局
- Stroke (stroke and TIA)(15 years since the first dose of hydroxychloroquine)
- Cardiac events (myocardial infarction(15 years since the first dose of hydroxychloroquine)
- Thrombosis of peripheral veins(15 years since the first dose of hydroxychloroquine)
- Venous thrombosis events(15 years since the first dose of hydroxychloroquine)
- Pulmonary embolism(15 years since the first dose of hydroxychloroquine)
研究者
yair levy
professor - head of internal medicine department
Meir Medical Center