CALCification as an early marker of vasculopathy and organ involvement in Systemic Sclerosis
- Conditions
- Scleroderma10010761
- Registration Number
- NL-OMON48902
- Lead Sponsor
- niversitair Medisch Centrum Groningen
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- Not specified
- Target Recruitment
- 120
SSc patients:;In order to be eligible to participate in this study as an SSc patient, a subject must meet all of the following criteria:;* 18 years and older;* Formal diagnosis of Systemic Sclerosis, as determined by a total of *9 from adding the maximum weight (score) in each of the following categories (2013 ACR/EULAR criteria):;o Skin thickening of the fingers of both hands extending proximal to the metacarpophalangeal joints (sufficient criterion) (9 points);o Skin thickening of the fingers (only count the higher score) ;* Puffy fingers (2 points);* Sclerodactyly of the fingers (distal to the metacarpophalangeal joints but proximal to the proximal interphalangeal joints) (4 points);o Fingertip lesions (only count the higher score) ;* Digital tip ulcers (2 points);* Fingertip pitting scars (3 points);o Telangiectasia (2 points);o Abnormal nailfold capillaries (2 points);o Pulmonary involvement (maximum score is 2);* Pulmonary arterial hypertension (2 points) ;* Interstitial lung disease (2 points);o Raynaud*s phenomenon (3 points);o SSc-related autoantibodies (maximum score is 3);* Anticentromere (3 points);* anti*topoisomerase I [anti*Scl-70] (3 points);* anti*RNA polymerase III (3 points);* Written informed consent;Controls:;In order to be eligible to participate in this study as a patient with primary Raynaud*s phenomenon, a subject must meet all of the following criteria:;* 18 years and older;* Negatieve antinuclear antibodies (ANA) ;* Normal nailfold capillairies ;* No underlying disease;* Written informed consent;Healthy controls:;In order to be eligible to participate in this study as a healthy control, a subject must meet all of the following criteria:;* 18 years and older;* No apparent underlying chronic disease;* No signs and symptoms suggesting Raynaud phenomenon or other vascular disease;* Written informed consent
A potential subject who meets any of the following criteria will be excluded from participation in this study:;* Women who are currently pregnant, planning to become pregnant, breastfeeding women, or women with child bearing potential not using appropriate contraceptive measures;* Patients who are mentally incompetent and cannot sign a Patient Informed Consent or are unwilling to sign a Patient Informed Consent;* Vascular event in the preceding 3 months;* Chemotherapy in the preceding 3 months;* Inflammation of unknown origin, sepsis, or vasculitis;The next criteria will also be used for the substudy concerning 18F-NaF PET/CT:;* Current active bone malignancy or in the previous 6 months ;* Disorders affecting bone metabolism, e.g. hyperparathyroidism, Paget*s disease ;* Patients who have claustrophobia
Study & Design
- Study Type
- Observational invasive
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method <p>1. Degree of serum T50;</p><br>
- Secondary Outcome Measures
Name Time Method