- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03189602
Pulmonary Artery Involvement in Takayasu's Arteritis
June 15, 2017 updated by: Peking Union Medical College Hospital
Pulmonary Artery Involvement in Takayasu's Arteritis: a Retrospective Study in China
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.
Study Overview
Status
Completed
Conditions
Detailed 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.
Study Type
Observational
Enrollment (Actual)
51
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Beijing
-
Beijing, Beijing, China, 100730
- Peking Union Medical College Hospital
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
14 years to 67 years (Child, Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Sampling Method
Probability Sample
Study Population
Takayasu's arteritis patients with pulmonary artery involvement
Description
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 Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Observational Models: Case-Only
- Time Perspectives: Retrospective
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Pulmonary Artery Systolic Blood Pressure
Time Frame: 1day
|
Pulmonary artery systolic blood pressure(PASP) assessed by transthoracic echocardiography when admission.
PASP>50mmHg is defined as pulmonary hypertension.
|
1day
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Investigators
- Study Chair: Juhong Shi, M.D, Peking Union Medical College Hospital
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
January 1, 2014
Primary Completion (Actual)
December 31, 2015
Study Completion (Actual)
December 31, 2015
Study Registration Dates
First Submitted
June 15, 2017
First Submitted That Met QC Criteria
June 15, 2017
First Posted (Actual)
June 16, 2017
Study Record Updates
Last Update Posted (Actual)
June 16, 2017
Last Update Submitted That Met QC Criteria
June 15, 2017
Last Verified
June 1, 2017
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- PUMCH-Pulmonary arteritis
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Yes
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Takayasu Arteritis
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Assistance Publique - Hôpitaux de ParisChugai PharmaceuticalCompleted
-
Instituto Nacional de Cardiologia Ignacio ChavezCompleted
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AbbVieActive, not recruitingTakayasu Arteritis (TAK)Argentina, Brazil, China, Japan, Korea, Republic of, Turkey
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Assistance Publique - Hôpitaux de ParisRecruitingArteritis | Systemic Vasculitis | Arteritis, TakayasuFrance
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Chinese Pulmonary Vascular Disease Research GroupRecruitingTakayasu Arteritis With Pulmonary Artery Involvement | Percutaneous Transluminal Pulmonary Angioplasty | PAH Targeted MedicationChina
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Beijing Institute of Heart, Lung and Blood Vessel...Peking University People's Hospital; Shanghai Zhongshan HospitalRecruiting
-
University of Sao PauloFederal University of São PauloUnknown
-
University of PennsylvaniaNational Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS) and other collaboratorsCompletedTakayasu's ArteritisUnited States, Canada
-
Assistance Publique - Hôpitaux de ParisNot yet recruiting