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

• Sponsor: Meir Medical Center (Other)
• Overall Status: Unknown status
• CT.gov ID: NCT02381587
• Collaborator: (none)
• Enrollment: 500
• Duration (Months): 12

Study Details

Study Description

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

Condition or Disease	Intervention/Treatment	Phase
Primary Sjogren Syndrome With Multisystem Involvement	Other: Retrospective study

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)

5. 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

Study Design

• Study Type: Observational
• Anticipated Enrollment: 500 participants
• Observational Model: Case-Only
• Time Perspective: Retrospective
• Official Title: Retrospective Study That Evaluate the Effect of HCG Treatment as a Cardiovascular Disease Morbidity Factor in Patients With Primary Sjogren Syndrome
• Study Start Date: Apr 1, 2015
• Anticipated Primary Completion Date: Apr 1, 2016
• Anticipated Study Completion Date: Apr 1, 2016

Outcome Measures

Primary Outcome Measures

1. Arterial cardiovascular events [15 years since the first dose of hydroxychloroquine]

Secondary Outcome Measures

1. Cardiac events (myocardial infarction [15 years since the first dose of hydroxychloroquine]

2. Thrombosis of peripheral veins [15 years since the first dose of hydroxychloroquine]

3. Stroke (stroke and TIA) [15 years since the first dose of hydroxychloroquine]

4. Venous thrombosis events [15 years since the first dose of hydroxychloroquine]

5. Pulmonary embolism [15 years since the first dose of hydroxychloroquine]

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

• Meir Medical Center

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: yair levy, professor - head of internal medicine department, Meir Medical Center
• ClinicalTrials.gov Identifier: NCT02381587
• Other Study ID Numbers: HCQ and sjogren
• First Posted: Mar 6, 2015
• Last Update Posted: Mar 6, 2015
• Last Verified: Mar 1, 2015

• Additional relevant MeSH terms: Sjogren's Syndrome; Cardiovascular Diseases; Syndrome

Study Results

No Results Posted as of Mar 6, 2015