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Registry for Chronic Obstructive Pulmonary Disease With Pulmonary Thromboembolism in China

Sponsor
Chinese Academy of Medical Sciences, Fuwai Hospital (Other)
Overall Status
Unknown status
CT.gov ID
NCT03185377
Collaborator
(none)
1,708
Enrollment
1
Location
45.6
Anticipated Duration (Months)
37.5
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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.

Condition or Disease Intervention/Treatment Phase

    Study Design

    Study Type:
    Observational [Patient Registry]
    Anticipated Enrollment :
    1708 participants
    Observational Model:
    Cohort
    Time Perspective:
    Prospective
    Official Title:
    The Study of Early Detection, Disease Course and Prognosis of Pulmonary Thromboembolism in Chronic Pulmonary Hypertension
    Actual Study Start Date :
    Mar 15, 2017
    Anticipated Primary Completion Date :
    Dec 31, 2020
    Anticipated Study Completion Date :
    Dec 31, 2020

    Outcome Measures

    Primary Outcome Measures

    1. All-cause mortality [3 years]

      mortality in %

    Secondary Outcome Measures

    1. COPD exacerbations [3 years]

      Total times

    2. venous thromboembolism recurrence [3 years]

      total times

    3. major bleeding [3 years]

      total times

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    40 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    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

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Beijing Chaoyang Hospital Beijing Beijing China 100043

    Sponsors and Collaborators

    • Chinese Academy of Medical Sciences, Fuwai Hospital

    Investigators

    None specified.

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Jianguo He, Chief of Pulmonary Vascular Disease Center, Chinese Academy of Medical Sciences, Fuwai Hospital
    ClinicalTrials.gov Identifier:
    NCT03185377
    Other Study ID Numbers:
    • 2016YFC1304402A
    First Posted:
    Jun 14, 2017
    Last Update Posted:
    Jun 14, 2017
    Last Verified:
    Jun 1, 2017
    Individual Participant Data (IPD) Sharing Statement:
    Undecided
    Plan to Share IPD:
    Undecided
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Additional relevant MeSH terms:
    Pulmonary Embolism
    Thromboembolism

    Study Results

    No Results Posted as of Jun 14, 2017