Comment Period Extended to 3/23/2015 for Notice of Proposed Rulemaking (NPRM) for FDAAA 801 and NIH Draft Reporting Policy for NIH-Funded Trials

Epidemiological Study of Chronic Thromboembolic Pulmonary Hypertension in China

This study is currently recruiting participants. (see Contacts and Locations)
Verified February 2014 by Fourth Military Medical University
Information provided by (Responsible Party):
Shengqing Li, Fourth Military Medical University Identifier:
First received: October 26, 2012
Last updated: February 26, 2014
Last verified: February 2014

Chronic thromboembolic pulmonary hypertension (CTPH) is associated with considerable morbidity and mortality. Its incidence after pulmonary embolism and associated risk factors are not well documented in Chinese population. We conducted a prospective, long-term, follow-up study to assess the incidence of symptomatic CTPH in consecutive patients with an acute episode of pulmonary embolism but without prior venous thromboembolism. Patients with unexplained persistent dyspnea during follow-up underwent transthoracic echocardiography and, if supportive findings were present, ventilation-perfusion lung scanning and pulmonary angiography. CTPH was considered to be present if systolic and mean pulmonary-artery pressures exceeded 40 mm Hg and 25 mm Hg, respectively; pulmonary-capillary wedge pressure was normal; and there was angiographic evidence of disease.

To Assess the Long-term Risk for Adverse Events After PE.

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective

Resource links provided by NLM:

Further study details as provided by Fourth Military Medical University:

Primary Outcome Measures:
  • The cumulative incidence of symptomatic CTEPH [ Time Frame: 2 years ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Risk factors for Recurrent VTE and CTEPH [ Time Frame: 2 years ] [ Designated as safety issue: No ]

Estimated Enrollment: 400
Study Start Date: October 2012
Estimated Study Completion Date: October 2015
Estimated Primary Completion Date: October 2015 (Final data collection date for primary outcome measure)
Consecutive patients with acute PE


Ages Eligible for Study:   18 Years to 80 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population

Consecutive patients with an acute episode of pulmonary embolism but without prior venous thromboembolism.


Inclusion Criteria:

  • Patients with an episode of acute symptomatic pulmonary embolism without prior pulmonary embolism or venous thrombosis

Exclusion Criteria:

  • Have other diseases (e.g., systemic sclerosis or severe emphysema) that could have caused nonthromboembolic pulmonary hypertension,
  • Have preexisting exertional dyspnea,
  • Geographically inaccessible for follow-up,
  • Decline to participate in the study.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its identifier: NCT01717092

Contact: Shengqing Li, MD, PhD +86-29-84771132

China, Shaanxi
Tangdu hospital Recruiting
Xi'an, Shaanxi, China, 710032
Contact: Yonghong Xie, MD    +86-29-84777725   
Xijing hospital Recruiting
Xi'an, Shaanxi, China, 710032
Contact: Yongping Yu, MD    +86-29-84771132   
Sub-Investigator: Yongping Yu, MD         
Sub-Investigator: Xinpeng Han, MD         
Sponsors and Collaborators
Fourth Military Medical University
  More Information

No publications provided

Responsible Party: Shengqing Li, MD, PhD, Associate Chief Physician, Associate Professor, Fourth Military Medical University Identifier: NCT01717092     History of Changes
Other Study ID Numbers: XJ-CTPH20121026
Study First Received: October 26, 2012
Last Updated: February 26, 2014
Health Authority: China: Food and Drug Administration processed this record on February 27, 2015