Epidemiological Study of Chronic Thromboembolic Pulmonary Hypertension in China

NCT ID: NCT01717092

Last Updated: 2014-02-27

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Total Enrollment

400 participants

Study Classification

OBSERVATIONAL

Study Start Date

2012-10-31

Study Completion Date

2015-10-31

Brief Summary

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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.

Detailed Description

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Conditions

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

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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Consecutive patients with acute PE

No interventions assigned to this group

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Air Force Military Medical University, China

OTHER

Sponsor Role lead

Responsible Party

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Shengqing Li

MD, PhD, Associate Chief Physician, Associate Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Tangdu hospital

Xi'an, Shaanxi, China

Site Status RECRUITING

Xijing hospital

Xi'an, Shaanxi, China

Site Status RECRUITING

Countries

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China

Central Contacts

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Shengqing Li, MD, PhD

Role: CONTACT

+86-29-84771132

Facility Contacts

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Yonghong Xie, MD

Role: primary

+86-29-84777725

Yongping Yu, MD

Role: primary

+86-29-84771132

Other Identifiers

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XJ-CTPH20121026

Identifier Type: -

Identifier Source: org_study_id

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