the Effect of HCG Treatment as a Cardiovascular Disease Morbidity Factor in Sjogren Syndrome Patients

• Conditions: Primary Sjogren Syndrome With Multisystem Involvement

• Registration Number: NCT02381587
• Lead Sponsor: Meir Medical Center

Brief Summary

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

Detailed Description

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:

1. Thrombosis of peripheral veins

2. Arterial cardiovascular events

3. Cardiac events (myocardial infarction

4. Stroke (stroke and TIA)

4. Venous thrombosis events 5. Pulmonary embolism In the study will be 500 patients

Inclusion criteria:

1. 18 years old

2. Both sexes

3. Patients that diagnosis in sjogren in treated in Meir Medical center in the years 2003-2014 And treated in Hydroxychloroquine at least a month.

Exclusion criteria:

1. Minors and special populations

2. Patients that treated in Hydroxychloroquine at less than a month.

3. Patient that participate in clinical trial and treat with investigational product

Basic Information
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Recruitment & Eligibility
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Study & Design

Study Timeline

• Study First Submitted: 2015-02-16
• Status Verified: 2015-03
• Study First Submitted QC: 2015-03-02
• Last Update Submitted: 2015-03-02
• Study First Posted: 2015-03-06
• Last Update Posted: 2015-03-06
• Study Start: 2015-04
• Primary Completion: 2016-04
• Study Completion: 2016-04

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 500

Inclusion Criteria

1. 18 years old
2. Both sexes
3. Patients that diagnosis in sjogren in treated in Meir Medical center in the years 2003-2014 And treated in Hydroxychloroquine at least a month.

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Exclusion Criteria

1. Minors and special populations
2. Patients that treated in Hydroxychloroquine at less than a month.
3. Patient that participate in clinical trial and treat with investigational product

Read More

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Arterial cardiovascular events	15 years since the first dose of hydroxychloroquine

Secondary Outcome Measures

Name	Time	Method
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