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

NCT02381587 | Unknown

• 1 other identifier: HCQ and sjogren
• Study Type: observational
• Target: 500
• Locations: 0 countries
• Sites: N/A

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

Conditions

Primary Sjogren Syndrome With Multisystem Involvement

Outcome Measures

Primary Outcomes (1)

• Arterial cardiovascular events

  15 years since the first dose of hydroxychloroquine

Secondary Outcomes (5)

• Cardiac events (myocardial infarction

  15 years since the first dose of hydroxychloroquine

• Thrombosis of peripheral veins

  15 years since the first dose of hydroxychloroquine

• Stroke (stroke and TIA)

  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

Interventions

Retrospective study OTHER

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

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients that diagnosis in sjogren in treated in Meir Medical center

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• Meir Medical Center: lead

MeSH Terms

Interventions

Retrospective Studies

Intervention Hierarchy (Ancestors)

Case-Control Studies; Epidemiologic Studies; Epidemiologic Study Characteristics; Epidemiologic Methods; Investigative Techniques; Cohort Studies; Health Care Evaluation Mechanisms; Quality of Health Care; Health Care Quality, Access, and Evaluation; Public Health; Environment and Public Health

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: professor - head of internal medicine department

Study Record Dates

• First Submitted: February 16, 2015
• First Posted: March 6, 2015
• Study Start: April 1, 2015
• Primary Completion: April 1, 2016
• Study Completion: April 1, 2016
• Last Updated: March 6, 2015

Record last verified: 2015-03