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Currently, the traditional disease activity of Takayasu arteritis is mainly based on National Institutes of Health criteria and the inactive cases don't need anti-inflammatory treatment. However, pathologic findings showed that there was still inflammatory activity in the affected vessels, and the follow-up data also found significant lesion progression in some inactive cases. Sixty inactive Takayasu arteritis patients will be recruited to determine whether these individuals are active by screening new inflammatory markers in this study. New inflammatory markers included tumor necrosis factor,interleukin-2,interleukin-6,interleukin-8,interleukin-10,high-sensitivity C-reactive protein, and 18f-FDG positron emission tomograph. According to new inflammatory markers, sixty patients will be divided into two categories: inactive patients (n=20) and active patients (n=40). And then, Forty active patients diagnosed by new inflammatory markers will be randomly assigned to either anti-inflammatory therapy group or control group. The changes of inflammatory activity and lesion progression will be observed during one-year follow up in all 60 patients.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Anti-inflammatory treatment group | Experimental | Prednisone and/or cyclophosphamide |
|
| Control group | No Intervention | No intervention |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Prednisone, cyclophosphamide | Drug | Prednisone 0.5mg/(kg•d) and/or cyclophosphamide 2mg/kg |
|
| Measure | Description | Time Frame |
|---|---|---|
| Lesion progression | Progression of previous lesion degree>20% or new lesion | baseline and 12 months |
| Measure | Description | Time Frame |
|---|---|---|
| Lesion progression | Progression of previous lesion degree>20% or new lesion | baseline, 3 months, 6 months, 9 months |
| Changes in plasma concentration of tumor necrosis factor | baseline, 3 months, 6 months, 9 months and 12 months |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Xiongjing Jiang, MD | Contact | 86-1088322385 | jxj103@hotmail.com | |
| Hui Dong, MD | Contact | +8615810161393 | donghui666@sina.com |
| Name | Affiliation | Role |
|---|---|---|
| Xiongjing Jiang, MD | Fuwai Hospital, National Center for Cardiovascular Disease, Chinese Academy of Medical Sciences and Peking Union Medical College | Principal Investigator |
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| ID | Term |
|---|---|
| D013625 | Takayasu Arteritis |
| ID | Term |
|---|---|
| D001015 | Aortic Arch Syndromes |
| D001018 | Aortic Diseases |
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
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| ID | Term |
|---|---|
| D011241 | Prednisone |
| D003520 | Cyclophosphamide |
| ID | Term |
|---|---|
| D011244 | Pregnadienediols |
| D011245 | Pregnadienes |
| D011278 | Pregnanes |
| D013256 | Steroids |
| D000072473 |
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| Changes in plasma concentration of interleukin-2 | baseline, 3 months, 6 months, 9 months and 12 months |
| Changes in plasma concentration of interleukin-6 | baseline, 3 months, 6 months, 9 months and 12 months |
| Changes in plasma concentration of interleukin-8 | baseline, 3 months, 6 months, 9 months and 12 months |
| Changes in plasma concentration of interleukin-10 | baseline, 3 months, 6 months, 9 months and 12 months |
| Changes in plasma concentration of high-sensitivity C-reactive protein | baseline, 3 months, 6 months, 9 months and 12 months |
| Changes in 18F-fluorodeoxyglucose uptake by positron emission tomograph | baseline, 3 months, 6 months, 9 months and 12 months |
| D001167 |
| Arteritis |
| D014657 | Vasculitis |
| D017445 | Skin Diseases, Vascular |
| D012871 | Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |
| Fused-Ring Compounds |
| D011083 | Polycyclic Compounds |
| D010752 | Phosphoramide Mustards |
| D009588 | Nitrogen Mustard Compounds |
| D009150 | Mustard Compounds |
| D006846 | Hydrocarbons, Halogenated |
| D006838 | Hydrocarbons |
| D009930 | Organic Chemicals |
| D063088 | Phosphoramides |
| D009943 | Organophosphorus Compounds |