Epidemiological Study of Chronic Thromboembolic Pulmonary Hypertension in China

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.

Study Overview

• Status: Unknown
• Conditions: To Assess the Long-term Risk for Adverse Events After PE.

• Study Type: Observational
• Enrollment (Anticipated): 400

Contacts and Locations

• Study Contact: Name: Shengqing Li, MD, PhD; Phone Number: +86-29-84771132; Email: shengqingli@gmail.com

Study Locations

• China
  • Shaanxi
    • Xi'an, Shaanxi, China, 710032
      • Recruiting
      • Xijing Hospital
      • Sub-Investigator: Xinpeng Han, MD
      • Sub-Investigator: Yongping Yu, MD
      • Contact: Yongping Yu, MD; Phone Number: +86-29-84771132; Email: yuyongping_6100@163.com
    • Xi'an, Shaanxi, China, 710032
      • Recruiting
      • Tangdu Hospital
      • Contact: Yonghong Xie, MD; Phone Number: +86-29-84777725; Email: xieyh65@yahoo.com.cn

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 80 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Probability Sample

Study Population

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

Description

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.

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort
Consecutive patients with acute PE

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
The cumulative incidence of symptomatic CTEPH	2 years

Secondary Outcome Measures

Outcome Measure	Time Frame
Risk factors for Recurrent VTE and CTEPH	2 years

Collaborators and Investigators

• Sponsor: Air Force Military Medical University, China

Study record dates

Study Major Dates

• Study Start: October 1, 2012
• Primary Completion (Anticipated): October 1, 2015
• Study Completion (Anticipated): October 1, 2015

Study Registration Dates

• First Submitted: October 26, 2012
• First Submitted That Met QC Criteria: October 26, 2012
• First Posted (Estimate): October 30, 2012

Study Record Updates

• Last Update Posted (Estimate): February 27, 2014
• Last Update Submitted That Met QC Criteria: February 26, 2014
• Last Verified: February 1, 2014

More Information

Terms related to this study

• Other Study ID Numbers: XJ-CTPH20121026