ClinicalTrials.gov
ClinicalTrials.gov Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT02381587
Recruitment Status : Unknown
Verified March 2015 by yair levy, Meir Medical Center.
Recruitment status was:  Not yet recruiting
First Posted : March 6, 2015
Last Update Posted : March 6, 2015
Sponsor:
Information provided by (Responsible Party):
yair levy, 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


Condition or disease Intervention/treatment
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)

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

Study Type : Observational
Estimated 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 : April 2015
Estimated Primary Completion Date : April 2016
Estimated Study Completion Date : April 2016

Resource links provided by the National Library of Medicine



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


Primary Outcome Measures :
  1. Arterial cardiovascular events [ Time Frame: 15 years since the first dose of hydroxychloroquine ]

Secondary Outcome Measures :
  1. Cardiac events (myocardial infarction [ Time Frame: 15 years since the first dose of hydroxychloroquine ]
  2. Thrombosis of peripheral veins [ Time Frame: 15 years since the first dose of hydroxychloroquine ]
  3. Stroke (stroke and TIA) [ Time Frame: 15 years since the first dose of hydroxychloroquine ]
  4. Venous thrombosis events [ Time Frame: 15 years since the first dose of hydroxychloroquine ]
  5. Pulmonary embolism [ Time Frame: 15 years since the first dose of hydroxychloroquine ]


Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Patients that diagnosis in sjogren in treated in Meir Medical center
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

Responsible Party: yair levy, professor - head of internal medicine department, Meir Medical Center
ClinicalTrials.gov Identifier: NCT02381587     History of Changes
Other Study ID Numbers: HCQ and sjogren
First Posted: March 6, 2015    Key Record Dates
Last Update Posted: March 6, 2015
Last Verified: March 2015

Additional relevant MeSH terms:
Cardiovascular Diseases
Disease
Joint Diseases
Musculoskeletal Diseases
Rheumatic Diseases
Salivary Gland Diseases
Mouth Diseases
Stomatognathic Diseases
Lacrimal Apparatus Diseases
Eye Diseases
Connective Tissue Diseases
Autoimmune Diseases
Immune System Diseases
Syndrome
Sjogren's Syndrome
Pathologic Processes
Arthritis, Rheumatoid
Arthritis
Xerostomia
Dry Eye Syndromes