NCT05388682

Brief Summary

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

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
200

participants targeted

Target at P75+ for all trials

Timeline
202mo left

Started Jan 2014

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress42%
Jan 2014Dec 2042

Study Start

First participant enrolled

January 19, 2014

Completed
8.3 years until next milestone

First Submitted

Initial submission to the registry

May 19, 2022

Completed
5 days until next milestone

First Posted

Study publicly available on registry

May 24, 2022

Completed
20.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2042

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2042

Last Updated

December 20, 2023

Status Verified

January 1, 2023

Enrollment Period

29 years

First QC Date

May 19, 2022

Last Update Submit

December 14, 2023

Conditions

Keywords

Percutaneous transluminal pulmonary angioplasty, Takayasu Arteritis with Pulmonary Artery Involvement

Outcome Measures

Primary Outcomes (8)

  • all cause death

    all cause death

    2014/1/1-2042/12/31

  • mean pulmonary arterial pressure change

    change of mean pulmonary arterial pressure after treatment

    2014/1/1-2042/12/31

  • pulmonary vascular resistance change

    chagne of pulmonary vascular resistance after treatment

    2014/1/1-2042/12/31

  • 6MWD change

    change of six minute walk distance after treatment

    2014/1/1-2042/12/31

  • peak VO2 change

    change of peak oxygen consumption after treatment

    2014/1/1-2042/12/31

  • NT-proBNP change

    change of NT-proBNP after treatment

    2014/1/1-2042/12/31

  • RV/LV change

    change of right ventricular end-diastolic diameter versus laboratory left ventricular end-diastolic diameterafter treatment

    2014/1/1-2042/12/31

  • CI change

    change of cardiac index after treatment

    2014/1/1-2042/12/31

Interventions

Percutaneous transluminal pulmonary angioplasty

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

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

You may qualify if:

  • patients diagnosed with Takayasu arteries with pulmonary arteries involvement

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Fuwai Hospital, National Center for Cardiovascular Diseases, Chinese Academy of Medical Sciences and Peking Union Medical College

Beijing, 100000, China

RECRUITING

Study Officials

  • zhihong Liu, doctor

    Fuwai Hospital, National Center for Cardiovascular Diseases, Chinese Academy of Medical Sciences and Peking Union Medical College

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Zhihong Liu, doctor

CONTACT

Study Design

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

Study Record Dates

First Submitted

May 19, 2022

First Posted

May 24, 2022

Study Start

January 19, 2014

Primary Completion (Estimated)

December 31, 2042

Study Completion (Estimated)

December 31, 2042

Last Updated

December 20, 2023

Record last verified: 2023-01

Data Sharing

IPD Sharing
Will not share

Locations