the Application of Diffusion Tensor Imaging in the Evaluation of Peripheral Neuropathy in ANCA Associated Vasculitis

NCT ID: NCT04923074

Last Updated: 2021-06-11

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Total Enrollment

50 participants

Study Classification

OBSERVATIONAL

Study Start Date

2021-07-31

Study Completion Date

2023-07-31

Brief Summary

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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

Detailed Description

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Conditions

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ANCA Associated Vasculitis

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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DTI group

the patient in this group will receive DTI evaluation

diffusion tensor imaging(DTI) evaluation

Intervention Type OTHER

DTI is a new kind of MRI technique to evaluate peripheral neuropathy

routine group

the patient in this group will receive routine evaluation

No interventions assigned to this group

Interventions

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diffusion tensor imaging(DTI) evaluation

DTI is a new kind of MRI technique to evaluate peripheral neuropathy

Intervention Type OTHER

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Second Affiliated Hospital, School of Medicine, Zhejiang University

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Jing Xue

Role: STUDY_CHAIR

2nd affiliated hospital of Zhejiang University, School of Medicine

Locations

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2nd affiliated hospital of Zhejiang University, School of Medicine

Hangzhou, Zhejiang, China

Site Status RECRUITING

Countries

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China

Central Contacts

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wenjia sun

Role: CONTACT

86 15869029727

ting zhang

Role: CONTACT

86 15888819691

Facility Contacts

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wenjia sun

Role: primary

86 15869029727

Other Identifiers

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2020-162

Identifier Type: -

Identifier Source: org_study_id

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