Registry for Chronic Obstructive Pulmonary Disease With Pulmonary Thromboembolism in China

June 13, 2017 updated by: Jianguo He, Chinese Academy of Medical Sciences, Fuwai Hospital

The Study of Early Detection, Disease Course and Prognosis of Pulmonary Thromboembolism in Chronic Pulmonary Hypertension

Chronic obstructive pulmonary disease (COPD) is closely related to venous thromboembolism (VTE). But it is difficult to identify VTE in COPD patients in clinical practice. Therefore, the prevalence data of PTE in COPD is limited. Pulmonary thromboembolism (PTE) is an important factor effecting patients outcomes, but existing researches only have short follow-up time less than 1 year. This study aim to develop an early detection system of PTE in COPD and explore the disease course and prognosis.

Study Overview

Status

Unknown

Conditions

Study Type

Observational

Enrollment (Anticipated)

1708

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • China
    • Beijing
      • Beijing, Beijing, China, 100043
        • Recruiting
        • Beijing Chaoyang Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

40 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

COPD patients

Description

Inclusion Criteria:

  • Patients hospitalized for chronic obstructive pulmonary disease (COPD) exacerbation

Exclusion Criteria:

  • Stable COPD patients
  • COPD hospitalized for definite causes other than pulmonary thromboembolism
  • Patients with malignant tumor
  • Patients with contraindications for CT pulmonary angiography
  • Psychopath

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
All-cause mortality
Time Frame: 3 years
mortality in %
3 years

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
COPD exacerbations
Time Frame: 3 years
Total times
3 years
venous thromboembolism recurrence
Time Frame: 3 years
total times
3 years
major bleeding
Time Frame: 3 years
total times
3 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Chinese Academy of Medical Sciences, Fuwai Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

March 15, 2017

Primary Completion (Anticipated)

December 31, 2020

Study Completion (Anticipated)

December 31, 2020

Study Registration Dates

First Submitted

June 11, 2017

First Submitted That Met QC Criteria

June 11, 2017

First Posted (Actual)

June 14, 2017

Study Record Updates

Last Update Posted (Actual)

June 14, 2017

Last Update Submitted That Met QC Criteria

June 13, 2017

Last Verified

June 1, 2017

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2016YFC1304402A

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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