NCT03185377

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
1,708

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Mar 2017

Typical duration for all trials

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 15, 2017

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

June 11, 2017

Completed
3 days until next milestone

First Posted

Study publicly available on registry

June 14, 2017

Completed
3.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2020

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2020

Completed
Last Updated

June 14, 2017

Status Verified

June 1, 2017

Enrollment Period

3.8 years

First QC Date

June 11, 2017

Last Update Submit

June 13, 2017

Conditions

COPDPTE - Pulmonary Thromboembolism

Outcome Measures

Primary Outcomes (1)

  • All-cause mortality

    mortality in %

    3 years

Secondary Outcomes (3)

  • COPD exacerbations

    3 years

  • venous thromboembolism recurrence

    3 years

  • major bleeding

    3 years

Eligibility Criteria

Age40 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

COPD patients

You may qualify if:

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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Beijing Chaoyang Hospital

Beijing, Beijing Municipality, 100043, China

RECRUITING

Biospecimen

Retention: SAMPLES WITH DNA

Serum and blood cell

MeSH Terms

Conditions

Pulmonary Disease, Chronic ObstructivePulmonary Embolism

Condition Hierarchy (Ancestors)

Lung Diseases, ObstructiveLung DiseasesRespiratory Tract DiseasesChronic DiseaseDisease AttributesPathologic ProcessesPathological Conditions, Signs and SymptomsEmbolismEmbolism and ThrombosisVascular DiseasesCardiovascular Diseases

Central Study Contacts

Yuanhua Yang, MD

CONTACT

13911773607yyh1031@sina.com

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Target Duration
3 Years
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Chief of Pulmonary Vascular Disease Center

Study Record Dates

First Submitted

June 11, 2017

First Posted

June 14, 2017

Study Start

March 15, 2017

Primary Completion

December 31, 2020

Study Completion

December 31, 2020

Last Updated

June 14, 2017

Record last verified: 2017-06

Locations

CN(1)