ANCA Associated Vasculitis Clinical Trial
Official title:
the Application of Diffusion Tensor Imaging(DTI) in the Evaluation of Peripheral Neuropathy in Anti-neutrophil Cytoplasmic Antibodies Associated Vasculitis(AAV)
NCT number | NCT04923074 |
Other study ID # | 2020-162 |
Secondary ID | |
Status | Recruiting |
Phase | |
First received | |
Last updated | |
Start date | July 2021 |
Est. completion date | July 2023 |
1. Include qualified 50 ANCA-associated vasculitis(AAV) patients; and the first 27 patients will be divided into 3 groups with different diffused tension image (DTI) parameters and to choose the best strategy; 2. On baseline, 6 months after treatment and 24 months after treatment, the AAV patients will accomplish the Birming-ham vasculitis activity score(BVAS) besides DTI; 3. The new serum biomarkers of AAV associated peripheral neuropathy will be measured by ELISA; (4) Another cohort with 50 patients with AAV associated peripheral neuropathy who were evaluated by traditional methods (electromyogram) and compared to the patients cohort that evaluated using DTI by cost-benefit analysis
Status | Recruiting |
Enrollment | 50 |
Est. completion date | July 2023 |
Est. primary completion date | July 2023 |
Accepts healthy volunteers | |
Gender | All |
Age group | 18 Years to 80 Years |
Eligibility | Inclusion Criteria: - age between 18-80 years old; - must fulfill 2012 criteria of ANCA associated vasculitis - presented with peripheral neuropathy diagnosed by specialists Exclusion Criteria: - the ANCA associated vasculitis is already in the stable stage after treatments - any vital organ dysfunction - active infection or cancer - can not finish DTI scan |
Country | Name | City | State |
---|---|---|---|
China | 2nd affiliated hospital of Zhejiang University, School of Medicine | Hangzhou | Zhejiang |
Lead Sponsor | Collaborator |
---|---|
Second Affiliated Hospital, School of Medicine, Zhejiang University |
China,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | To assess the optimal b-value (a key parameter) for DTI in AAV associated peripheral neuropathy | b-value is a key technique parameter for DTI, which will decide the quality of DTI image | 2 years | |
Secondary | the association between normative diffusion value of DTI (FA and ADC value) and disease activity activity score of AAV (BVAS). | Birmingham Vasculitis Activity Score (BVAS) is a index of vasculitis disease activity, with the score range 0-63. Fractional anisotropy(FA) and apparent diffusion coefficient(ADC) are two parameters that can be read through DTI image . | 2 years | |
Secondary | the association between normative diffusion value of DTI (FA and ADC value) and serum biomarkers of AAV associated neuropathy | sCD163, Nfl(neurofilament light polypeptide)and OPN(osteopontin)are new biomarkers of peripheral neuropathy | 2 years |
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