Treatment of Patients With Takayasu Arteritis Complicated With Pulmonary Artery Involvement

December 14, 2023 updated by: Chinese Pulmonary Vascular Disease Research Group

Observation of Long Term Effect of Medical and PTPA Treatment on Patients With Takayasu Arteritis Complicated With Pulmonary Artery Involvement

  1. Evaluate the effect of medical treatment and percutaneous transluminal pulmonary angioplasty on takayasu arteritis with pulmonary artery involvement
  2. evaluate the efficacy of FAPI in predicting the activity and treatment efficacy of takayasu arteritis with pulmonary artery involvement

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed Description

At baseline, FAPI and FDG are performed to evaluate the activity of takayasu arteritis with pulmonary artery involvement. FAPI is also used to predict the treatment efficacy and prognosis of takayasu arteritis with pulmonary artery involvement.

Study Type

Observational

Enrollment (Estimated)

200

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • China
      • Beijing, China, 100000
        • Recruiting
        • Fuwai Hospital, National Center for Cardiovascular Diseases, Chinese Academy of Medical Sciences and Peking Union Medical College
        • Contact:
          • Zhihong Liu, doctor
          • Phone Number: 13269276067

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

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

patients diagnosed with Takayasu arteries with pulmonary arteries involvement received either medical or percutaneous transluminal pulmonary angioplasty

Description

Inclusion Criteria:

  • patients diagnosed with Takayasu arteries with pulmonary arteries involvement

Exclusion Criteria:

  • Patients had pulmonary artery stenosis arising from CTEPH, fibrosing mediastinitis and congenital pulmonary artery stenosis

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: Cohort
  • Time Perspectives: Prospective

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
all cause death
Time Frame: 2014/1/1-2042/12/31
all cause death
2014/1/1-2042/12/31
mean pulmonary arterial pressure change
Time Frame: 2014/1/1-2042/12/31
change of mean pulmonary arterial pressure after treatment
2014/1/1-2042/12/31
pulmonary vascular resistance change
Time Frame: 2014/1/1-2042/12/31
chagne of pulmonary vascular resistance after treatment
2014/1/1-2042/12/31
6MWD change
Time Frame: 2014/1/1-2042/12/31
change of six minute walk distance after treatment
2014/1/1-2042/12/31
peak VO2 change
Time Frame: 2014/1/1-2042/12/31
change of peak oxygen consumption after treatment
2014/1/1-2042/12/31
NT-proBNP change
Time Frame: 2014/1/1-2042/12/31
change of NT-proBNP after treatment
2014/1/1-2042/12/31
RV/LV change
Time Frame: 2014/1/1-2042/12/31
change of right ventricular end-diastolic diameter versus laboratory left ventricular end-diastolic diameterafter treatment
2014/1/1-2042/12/31
CI change
Time Frame: 2014/1/1-2042/12/31
change of cardiac index after treatment
2014/1/1-2042/12/31

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Chinese Pulmonary Vascular Disease Research Group

Investigators

  • Principal Investigator: zhihong Liu, doctor, Fuwai Hospital, National Center for Cardiovascular Diseases, Chinese Academy of Medical Sciences and Peking Union Medical College

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 19, 2014

Primary Completion (Estimated)

December 31, 2042

Study Completion (Estimated)

December 31, 2042

Study Registration Dates

First Submitted

May 19, 2022

First Submitted That Met QC Criteria

May 19, 2022

First Posted (Actual)

May 24, 2022

Study Record Updates

Last Update Posted (Estimated)

December 20, 2023

Last Update Submitted That Met QC Criteria

December 14, 2023

Last Verified

January 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • TAPAI

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

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.

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