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

NCT ID: NCT02381587

Last Updated: 2015-03-06

Basic Information

• Recruitment Status: UNKNOWN
• Total Enrollment: 500 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2015-04-30
• Study Completion Date: 2016-04-30

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

Conditions

Primary Sjogren Syndrome With Multisystem Involvement

Study Design

• Observational Model Type: CASE_ONLY
• Study Time Perspective: RETROSPECTIVE

Interventions

Retrospective study

no interventional study - Retrospective study that valuate The effect of HCQ treatment in cardiovascular AVENTS IN patients with primary sjogren syndrome

Intervention Type: OTHER

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Meir Medical Center

OTHER

Sponsor Role: lead

Responsible Party

yair levy

professor - head of internal medicine department

Responsibility Role: PRINCIPAL_INVESTIGATOR

Other Identifiers

HCQ and sjogren

Identifier Type: -

Identifier Source: org_study_id