Trials / Unknown

UnknownNCT02126098

Observation Study of Clinical Manifestation and Outcome in Chinese Patients With Pulmonary Vasculitis

Cohort Study of Chinese Patients With Pulmonary Vasculitis

Status: Unknown
Phase: —
Study type: Observational
Enrollment: 100 (estimated)

Sponsor: Peking Union Medical College Hospital · Academic / Other
Sex: All
Age: 18 Years – 75 Years
Healthy volunteers: Not accepted

Summary

The purpose of this study is to observe the clinical manifestation, Lab findings including chest CT scans, pathological findings and outcomes in chinese patients with pulminary vasculitis.

Detailed description

Presentation of patient with suspected vasculitis 1. Established diagnosis Clinical findings Laboratory workup Tissue biopsy Angiogram where appropriate 2. Evaluating respiratory system Chest HRCT Pulmonary function test Bronchoscopy exam(BALF, TBB) Lung biopsy(needle biopsy, VAST) 3. screening underlying damage to other system Paranasal sinus, vision \& audition Nervous system Kidney Gastrointestinal tract Heart \& vessel Skin Hematology Muscle, bone \& joint 4. Treatment 5. Prognosis Evaluation 1. Study visits occurred at baseline; at weeks 4; and at 2, 4, 6,12,18,24,30 months. 2. Disease activity was measured on the basis of the BVAS/WG and the physician's global assessment. 3. Damage related to disease or treatment was scored according to the Vasculitis Damage Index (scores for this index range from 0 to 64, with higher scores in- dicating more severe damage). 4. Health related quality of life was scored with the use of the Med- ical Outcomes Study 36-Item Short-Form Health Survey (SF-36).Scores on this scale range from 0 to 100, with higher scores indicating better health. 5. Serial serum samples were tested for proteinase 3-ANCA and myeloperoxidase-ANCA by means of a direct enzyme-linked immunosorbent assay (ELISA).

Conditions

Timeline

Start date: 2014-05-01
Primary completion: 2017-11-01
Completion: 2017-12-01
First posted: 2014-04-29
Last updated: 2014-04-29

Locations

1 site across 1 country: China

Source: ClinicalTrials.gov record NCT02126098. Inclusion in this directory is not an endorsement.