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

Primary Sjogren Syndrome With Multisystem Involvement Clinical Trial

— HAS  

Official title:

Retrospective Study That Evaluate the Effect of HCG Treatment as a Cardiovascular Disease Morbidity Factor in Patients With Primary Sjogren Syndrome

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT02381587
• Other study ID #: HCQ and sjogren
• Status: Not yet recruiting
• Phase: N/A
• First received: February 16, 2015
• Last updated: March 2, 2015
• Start date: April 2015
• Est. completion date: April 2016

Study information

• Verified date: March 2015
• Source: Meir Medical Center
• Contact: n/a
• Is FDA regulated: No
• Health authority: Israel: Ethics Commission
• Study type: Observational

Clinical Trial 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

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

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 500
• Est. completion date: April 2016
• Est. primary completion date: April 2016
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Observational Model: Case-Only, Time Perspective: Retrospective

Related Conditions & MeSH terms

• Cardiovascular Diseases
• Primary Sjogren Syndrome With Multisystem Involvement
• Sjogren's Syndrome
• Syndrome

Intervention

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

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Meir Medical Center

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Arterial cardiovascular events		15 years since the first dose of hydroxychloroquine	No
Secondary	Cardiac events (myocardial infarction		15 years since the first dose of hydroxychloroquine	No
Secondary	Thrombosis of peripheral veins		15 years since the first dose of hydroxychloroquine	No
Secondary	Stroke (stroke and TIA)		15 years since the first dose of hydroxychloroquine	No
Secondary	Venous thrombosis events		15 years since the first dose of hydroxychloroquine	No
Secondary	Pulmonary embolism		15 years since the first dose of hydroxychloroquine	No