CClinicalTrials.gg
Status unknownNCT02381587HASUpdated Mar 6, 2015

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

An observational study in Primary Sjogren Syndrome With Multisystem Involvement, sponsored by Meir Medical Center. Status unknown. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2015-03-06.

Sponsored by Meir Medical Center · Observational

The sponsor has not verified this record recently (last verified Mar 2015), so the status shown — last known as Not yet recruiting — may be out of date.
Study type
Observational
Model
Case-only
Time perspective
Retrospective
Enrollment
500
Ages
18 Years and older
Sex
All
01

Study 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

Read the 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)
  1. 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
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Conditions studied

  • Primary Sjogren Syndrome With Multisystem Involvement
03

In context

Sjogren's Syndrome

371 studies on the registry are indexed under Sjogren's Syndrome; 104 are open to participants now.

This study's planned enrollment of 500 is above the median of 114 across 113 observational studies indexed under Sjogren's Syndrome.

Browse Sjogren's Syndrome studies →

Lead sponsor

Meir Medical Center is the lead sponsor of 389 studies on the registry; 34 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Non-probability sample

Study population

Patients that diagnosis in sjogren in treated in Meir Medical center

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

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
05

Study design

Observational model
Case-only
Time perspective
Retrospective
Enrollment
500 participants (estimated)
Patient registry
No

Interventions

  • OtherRetrospective study

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

06

What researchers measure

Primary outcomes

  1. Arterial cardiovascular events

    Time frame: 15 years since the first dose of hydroxychloroquine

Secondary outcomes

  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

07

Study locations

No study locations are listed for this record.

08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Mar 6, 2015, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT02381587
Lead sponsor
Meir Medical Center
Responsible party
yair levy (professor - head of internal medicine department, Meir Medical Center) — Principal investigator
First posted
Mar 6, 2015
Start date
Apr 2015
Primary completion
Apr 2016 (estimated)
Completion
Apr 2016 (estimated)
Last update
Mar 6, 2015

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is status unknown, as verified in Mar 2015. You cannot join it, but the record below documents what was studied.

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