evaluation of atherosclerotic vascular lesions and terminal diseases as well as cardiovascular risk factors and experimental biomarkers in patients with primary sjögren-syndrome
- Conditions
- M35.0I70.9Sicca syndrome [Sjögren]Generalized and unspecified atherosclerosis
- Registration Number
- DRKS00026261
- Lead Sponsor
- Medizinische Hochschule Hannover in Kooperation mit der Else-Kröner-Fresenius-Stiftung
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Complete
- Sex
- All
- Target Recruitment
- 317
Inclusion criteria for patient population:
- Age of majority (>18)
- ability to give informed consent is given
- confirmed diagnosis of primary Sjögren's syndrome (at least 2/3 criteria from the classification criteria for pSS of the American College of Rheumatology/European League Against Rheumatism 2016)
- At least 5 years cancer free survival
Inclusion criteria for control subjects:
- Age of majority (>18)
- Ability to give informed consent is given
(matched recruitment by age and sex to patient population).
Exclusion criteria for pSS patients
- Active cancer or cancer that occurred less than five years ago.
- Incapable of giving informed consent
- not at the age of majority (>18 yrs.)
- Pregnancy
- Not fulfilling at least 2/3 classification criteria as defined by the American College of Rheumatology/European League Against Rheumatism of 2016.
- known arterial occlusive diseases (peripheral arterial occlusive disease, coronary heart disease, stroke, myocardial infarction)
Exclusion criteria for control subjects
- not at the age of majority (>18 yrs.)
- Incapable of giving informed consent
- Active cancer or cancer that occurred less than five years ago
- Pregnancy
- known arterial occlusive diseases (peripheral arterial occlusive disease, coronary heart disease)
- known underlying rheumatic/inflammatory diseases, especially vasculitides, rheumatoid arthritis or systemic lupus erythematosus
Study & Design
- Study Type
- observational
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method