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

NCT04923074 | Unknown

• 1 other identifier: 2020-162
• Study Type: observational
• Target: 50
• Locations: 1 country
• Sites: 1

Brief Summary

1. 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. 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. 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

Conditions

ANCA Associated Vasculitis

Keywords

peripheral neuropathy

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (2)

• the association between normative diffusion value of DTI (FA and ADC value) and disease activity activity score of AAV (BVAS).

  2 years

• the association between normative diffusion value of DTI (FA and ADC value) and serum biomarkers of AAV associated neuropathy

  2 years

Study Arms (2)

DTI group

the patient in this group will receive DTI evaluation

Other: diffusion tensor imaging(DTI) evaluation

routine group

the patient in this group will receive routine evaluation

Interventions

diffusion tensor imaging(DTI) evaluation OTHER

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

DTI group

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

adult AAV patients with peripheral neuropathy

You may qualify if:

• age between 18-80 years old；
• must fulfill 2012 criteria of ANCA associated vasculitis
• presented with peripheral neuropathy diagnosed by specialists

You may not qualify if:

• 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

Sponsors & Collaborators

• Second Affiliated Hospital, School of Medicine, Zhejiang University: lead

Study Sites (1)

2nd affiliated hospital of Zhejiang University, School of Medicine

Hangzhou, Zhejiang, 310000, China

RECRUITING

MeSH Terms

Conditions

Anti-Neutrophil Cytoplasmic Antibody-Associated Vasculitis; Peripheral Nervous System Diseases

Condition Hierarchy (Ancestors)

Systemic Vasculitis; Vasculitis; Vascular Diseases; Cardiovascular Diseases; Skin Diseases, Vascular; Skin Diseases; Skin and Connective Tissue Diseases; Autoimmune Diseases; Immune System Diseases; Neuromuscular Diseases; Nervous System Diseases

Study Officials

• Jing Xue

  2nd affiliated hospital of Zhejiang University, School of Medicine

  STUDY CHAIR

Central Study Contacts

wenjia sun

CONTACT

86 15869029727; sunwinjoy@zju.edu.cn

ting zhang

CONTACT

86 15888819691; zhangtingpumc@163.com

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 1, 2021
• First Posted: June 11, 2021
• Study Start: July 1, 2021
• Primary Completion: July 1, 2023
• Study Completion: July 1, 2023
• Last Updated: June 11, 2021

Record last verified: 2021-06

Locations

CN (1)