Systemic damage and quality of life in patients with ANCA-associated vasculitis

Completed

Conditions: ANCA-associated vasculitis
granulomatosis with polyangitis
Wegener's disease
10027946
10029149
10057166

Registration Number: NL-OMON42996

Lead Sponsor: oordwest Ziekenhuisgroep

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Completed

Sex: Not specified

Target Recruitment: 140

Inclusion Criteria

In order to participate in this study, a subject must meet all of the following criteria:
* Diagnosis ANCA-associated vasculitis in accordance with the Chapel Hill Consensus Conference guidelines
* Age * 18 years

Exclusion Criteria

Not willing or able to participate

Study & Design

Study Type: Observational invasive

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>Main study parameter/endpoint<br /><br>1. Prevalence of cardiovascular disease in ANCA-associated vasculitis<br /><br>- Manifest cardiovascular disease: coronary artery disease,<br /><br>cerebrovascular disease, peripheral vascular disease, renal insufficiency, ECG<br /><br>abnormalities<br /><br>- Subclinical cardiovascular disease: advanced glycemic end products<br /><br>- Cardiovascular risk factors in ANCA-associated vasculitis: (regulated)<br /><br>hypertension, dyslipidemia, microalbuminuria, diabetes mellitus, renal<br /><br>insufficiency, smoking history<br /><br>- Cardiovascular risk management<br /><br><br /><br>2. QOL in ANCA-associated vasculitis<br /><br>- Quality of life (SF-36, EQ-5D-5L questionnaires)<br /><br>- Painscore (VAS)<br /><br>- Becks Depression Interventory (BDI)<br /><br>- Risk factors for depression: education level, marital status, employment<br /><br>status, drug/alcohol abuse.</p><br>

Secondary Outcome Measures

Name	Time	Method
<p>3. The association between point 1-2 and disease acitivity (BVAS, inflammation<br /><br>parameters, painscores, clinical manifestations). The association between point<br /><br>2 and damage (i.e. VDI, painscores)<br /><br>4. 5-year mortality and cardiovacular events in ANCA-associated vasculitis<br /><br>patients and the association between these endpoints and classical risk factors<br /><br>and disease characteristics. </p><br>