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| Name | Class |
|---|---|
| Central South University | OTHER |
| The Third Xiangya Hospital of Central South University | OTHER |
| Hunan Provincial People's Hospital | OTHER |
| Xiangtan Central Hospital |
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This study aimed to explore the incidence of Anti-neutrophil cytoplasmic antibody (ANCA）-associated vasculitis (AAV) progression and its association with adverse consequences. It will enroll approximately 500 AAV patients in Hunan province of China and follow-up for at least 5 years. Demographic characteristics, clinical and laboratory data will be collected at baseline and every follow-up. The principal clinical outcomes of the study consist of end stage renal disease (ESRD) and death.
The study is a multicenter prospective cohort study, aimed to explore the incidence of AAV and its progression and association with adverse consequences. The study will establish a baseline cohort of 500 AAV patients in Hunan province of China. The follow-up will be conducted for at least 5 years until death or starting renal replacement therapy or dropout. Their demographic characteristics, clinical data, laboratory and imaging examinations will be collected at baseline and every follow-up.
The baseline visit includes the following items: detailed demographics, medical and family history, medication history, health behaviors, physical activity, and anthropometric measures. The laboratory parameters of chemistry test. After the baseline visit, participants will return annually for follow-up visits and evaluation. The evaluating items of follow-up visits are similar to the baseline visit, and sample collection.
The principal clinical outcomes of the study can be broadly categorized as end stage renal disease and death. Death is further clarified as cardiac, infectious, renal, others, or unknown.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Xiangya Hospital |
| ||
| The Second Xiangya Hospital |
| ||
| The Third Xiangya Hospital |
| ||
| Hunan Provincial People's Hospital |
| ||
| Xiangtan Central Hospital |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| No Intervention | Other | No Intervention |
|
| Measure | Description | Time Frame |
|---|---|---|
| Death | death from any cause | from date of baseline examination until the date of death from any cause, up to 60 months |
| End stage renal disease or significant loss of renal function | start of chronic dialysis or renal transplantation or irreversible development of glomerular filtration rate <15 ml/minute per 1.73m(2) | from date of baseline examination until the date of first documented end stage renal disease or date of death from any cause, whichever came first, up to 60 months |
| Measure | Description | Time Frame |
|---|---|---|
| Disease activity | assessed by the proportion of patients with severe flares | Five years |
| Adverse events | a. deaths (from all causes); b. grade 3 or higher infections; c. malignant conditions; d. venous thromboembolic events; e. cardiovascular events; f. hospitalizations |
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Inclusion Criteria:
Exclusion Criteria:
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The study enrolled all the AAV patients that fulfill 2012 criteria of ANCA associated vasculitis and agree to sign informed
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Yong Zhong, doctor | Contact | +86073189753025 | zhongyong121@163.com | |
| Ting Meng, doctor | Contact | +86073184327431 | mengting252@163.com |
| Name | Affiliation | Role |
|---|---|---|
| Xiangcheng Xiao, doctor | Xiangya Hospital of Central South University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Xiangya hospital | Recruiting | Changsha | Hunan | 410008 | China |
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| ID | Term |
|---|---|
| D056648 | Anti-Neutrophil Cytoplasmic Antibody-Associated Vasculitis |
| D007676 | Kidney Failure, Chronic |
| ID | Term |
|---|---|
| D056647 | Systemic Vasculitis |
| D014657 | Vasculitis |
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
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| OTHER |
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| Five years |
| D017445 |
| Skin Diseases, Vascular |
| D012871 | Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |
| D001327 | Autoimmune Diseases |
| D007154 | Immune System Diseases |
| D051436 | Renal Insufficiency, Chronic |
| D051437 | Renal Insufficiency |
| D007674 | Kidney Diseases |
| D014570 | Urologic Diseases |
| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D052801 | Male Urogenital Diseases |
| D002908 | Chronic Disease |
| D020969 | Disease Attributes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |