Epidemiological Study of Chronic Thromboembolic Pulmonary Hypertension in China

The recruitment status of this study is unknown because the information has not been verified recently.
Verified February 2014 by Fourth Military Medical University.
Recruitment status was  Recruiting
Information provided by (Responsible Party):
Shengqing Li, Fourth Military Medical University
ClinicalTrials.gov 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
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Please refer to this study by its ClinicalTrials.gov identifier: NCT01717092

Contact: Shengqing Li, MD, PhD +86-29-84771132 shengqingli@gmail.com

China, Shaanxi
Tangdu hospital Recruiting
Xi'an, Shaanxi, China, 710032
Contact: Yonghong Xie, MD    +86-29-84777725    xieyh65@yahoo.com.cn   
Xijing hospital Recruiting
Xi'an, Shaanxi, China, 710032
Contact: Yongping Yu, MD    +86-29-84771132    yuyongping_6100@163.com   
Sub-Investigator: Yongping Yu, MD         
Sub-Investigator: Xinpeng Han, MD         
Sponsors and Collaborators
Fourth Military Medical University
  More Information

Responsible Party: Shengqing Li, MD, PhD, Associate Chief Physician, Associate Professor, Fourth Military Medical University
ClinicalTrials.gov 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

ClinicalTrials.gov processed this record on May 26, 2016