M35.0 I70.9
Conditions
Interventions
Group 1: Patients with pSS
- Carotid Doppler sonography with measurement of cIMT on both sides
Ankle-brachial index survey by pocket Doppler-assisted blood pressure measurement on all extremities
-
Sponsors
Medizinische Hochschule Hannover in Kooperation mit der Else-Kröner-Fresenius-Stiftung
Eligibility
Sex/Gender
All
Age
18 Years to 80 Years
Inclusion criteria
Inclusion criteria: 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
Exclusion criteria: 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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Proof of subclinical atherosclerosis based on detection of plaque in the common carotid artery, detection of increased intima-media thickness in the common carotid artery. (detection 1 and 2 are provided by carotid Doppler sonography) or the detection of a pathological ankle-brachial index by assessing the systolic blood pressure values via Doppler measurement of the pulses at the brachial, dorsal and posterior tibial arteries. These examinations will be performed in one examination block together with the study clarification, anamnesis and blood sampling within the inclusion period from 07.09.2021 to 31.03.2022. | — |
Secondary
| Measure | Time frame |
|---|---|
| - Presence of cardiovascular risk factors (determined by blood sampling and anamnesis questionnaire) - Presence of atherosclerotic terminal diseases (determined via anamnesis questionnaire) - Influence of hydrocholorquin (assessed by anamnesis) - Presence of increased concentrations of MAZ-antibodies or new biomarkers (After the blood sampling, the samples are professionally processed in the laboratory and analyzed by ELISA (Maz-AK) and other analytical methods (PCR and electrophoresis). Blood sampling and anamnesis will be performed in one examination block at one time within the inclusion period (07.09.21 to 31.03.22) | — |
Countries
Germany
Contacts
Public ContactNadine Zehrfeld
Klinik für Rheumatologie und Immunologie Medizinische Hochschule Hannover
Outcome results
None listed