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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT03189602
Other study ID # PUMCH-Pulmonary arteritis
Secondary ID
Status Completed
Phase N/A
First received June 15, 2017
Last updated June 15, 2017
Start date January 1, 2014
Est. completion date December 31, 2015

Study information

Verified date June 2017
Source Peking Union Medical College Hospital
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

The purpose of this study is to analyze the clinical manifestations, imaging features, and prognosis-related factors of pulmonary artery (PA) involvement in Takayasu's arteritis (TA), and to explore the early clinical features of PA involvement in TA patients.


Description:

Takayasu's arteritis patients with pulmonary artery involvement were enrolled into this study. The demographic information of the patients (age, sex, course of disease), symptoms at their admissions (cough, hemoptysis, dyspnea, palpitations, fever), laboratory examinations (blood lab routines, erythrocyte sedimentation rate, C-reactive protein), and imaging examinations (vascular ultrasonography, computed tomographic angiography, echocardiography, chest CT, CTPA, pulmonary perfusion imaging, pulmonary angiography, PET/CT) were collected by reviewing the cases. The prognostic information was collected by telephone follow-up. The follow-up end point was December 2015.


Recruitment information / eligibility

Status Completed
Enrollment 51
Est. completion date December 31, 2015
Est. primary completion date December 31, 2015
Accepts healthy volunteers No
Gender All
Age group 14 Years to 67 Years
Eligibility Inclusion Criteria:

- 1.Meet the diagnostic criteria of TA as defined by the American College of Rheumatology (ACR).

- 2.PA involvement: meet at least one of three items: (1) at least one of computed tomographic pulmonary angiography (CTPA), pulmonary perfusion imaging, or pulmonary arteriography suggests thickening of vessel wall, stenosis, aneurysm, or occlusion; (2) 18F-fluorodeoxyglucose positron emission tomography/computed tomography (PET/CT) suggests high intake of local radioactive material in pulmonary artery wall; (3) pulmonary artery systolic blood pressure is higher than 50 mmHg assessed by transthoracic echocardiography (defined as PAH), without left ventricular disease.

Exclusion Criteria:

Study Design


Locations

Country Name City State
China Peking Union Medical College Hospital Beijing Beijing

Sponsors (1)

Lead Sponsor Collaborator
Peking Union Medical College Hospital

Country where clinical trial is conducted

China, 

Outcome

Type Measure Description Time frame Safety issue
Primary Pulmonary Artery Systolic Blood Pressure Pulmonary artery systolic blood pressure(PASP) assessed by transthoracic echocardiography when admission. PASP>50mmHg is defined as pulmonary hypertension. 1day
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