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Epidemiological Study of Chronic Thromboembolic Pulmonary Hypertension in China

This study is currently recruiting participants.
Verified October 2012 by Fourth Military Medical University
Sponsor:
Information provided by (Responsible Party):
Shengqing Li, Fourth Military Medical University
ClinicalTrials.gov Identifier:
NCT01717092
First received: October 26, 2012
Last updated: NA
Last verified: October 2012
History: No changes posted
  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:

U.S. FDA Resources

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 2014
Estimated Primary Completion Date: October 2014 (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
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.

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
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
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            
Tangdu hospital Recruiting
Xi'an, Shaanxi, China, 710032
Contact: Yonghong Xie, MD     +86-29-84777725     xieyh65@yahoo.com.cn    
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
ClinicalTrials.gov Identifier: NCT01717092     History of Changes
Other Study ID Numbers: XJ-CTPH20121026
Study First Received: October 26, 2012
Last Updated: October 26, 2012
Health Authority: China: Food and Drug Administration

Additional relevant MeSH terms:
Hypertension, Pulmonary
Lung Diseases
Respiratory Tract Diseases

ClinicalTrials.gov processed this record on May 22, 2013