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Epidemiological Study of Chronic Thromboembolic Pulmonary Hypertension in China

The recruitment status of this study is unknown. The completion date has passed and the status has not been verified in more than two years.
Verified February 2014 by Fourth Military Medical University.
Recruitment status was:  Recruiting
Sponsor:
Information provided by (Responsible Party):
Shengqing Li, Fourth Military Medical University
ClinicalTrials.gov Identifier:
NCT01717092
First received: October 26, 2012
Last updated: February 26, 2014
Last verified: February 2014
  Purpose
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.

Condition
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 ]

Secondary Outcome Measures:
  • Risk factors for Recurrent VTE and CTEPH [ Time Frame: 2 years ]

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)
Groups/Cohorts
Consecutive patients with acute PE

  Eligibility

Ages Eligible for Study:   18 Years to 80 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population
Consecutive patients with an acute episode of pulmonary embolism but without prior venous thromboembolism.
Criteria

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 ClinicalTrials.gov identifier: NCT01717092

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

Locations
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

ClinicalTrials.gov processed this record on March 24, 2017