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

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

Status

Active, not recruiting

Phases

Unknown

Study type

Observational

Source

NL-OMON

Registry ID

NL-OMON42996

Enrollment

140

Registered

2016-08-31

Start date

2016-11-29

Completion date

Unknown

Last updated

2024-04-23

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

ANCA-associated vasculitis granulomatosis with polyangitis Wegener's disease

Interventions

None listed

Eligibility

Age

18 Years to 99 Years

Inclusion criteria

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

Exclusion criteria: Not willing or able to participate

Design outcomes

Primary

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

Measure

Time frame

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

—

Secondary

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

Countries

Netherlands

Outcome results