COPDNCT03185377
Registry for Chronic Obstructive Pulmonary Disease With Pulmonary Thromboembolism in China
An observational study of COPD and PTE - Pulmonary Thromboembolism, run by Chinese Academy of Medical Sciences, Fuwai Hospital at 1 site in China.
Trial 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. Read more about this study
- Who is it for?
- Ages 40 years and older
- Conditions the study is for
- COPD, PTE - Pulmonary Thromboembolism
- How many people
- 1,708 participants
- Where
- 1 siteChina
- Study dates
- 15 Mar 2017to 31 Dec 2020
- How long will I take part?
- 3 Years
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 40 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: COPD patients
Who may be able to join
- Patients hospitalized for chronic obstructive pulmonary disease (COPD) exacerbation
Who cannot join
- Stable COPD patients
- COPD hospitalized for definite causes other than pulmonary thromboembolism
- Patients with malignant tumor
- Patients with contraindications for CT pulmonary angiography
- Psychopath
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Beijing Chaoyang Hospital
Beijing, Beijing Municipality, 100043
Yuanhua Yang, MD, 13911773607, yyh1031@sina.com
About this study
Official title: 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.
- Conditions
- COPD, PTE - Pulmonary Thromboembolism
- Medical subject headings
- Pulmonary Disease, Chronic Obstructive, Pulmonary Embolism
What is being measured
The primary outcome is the main question the study is designed to answer.
All-cause mortality
mortality in %
Measured: 3 years
Secondary outcomes (3)
COPD exacerbations
Total times
Measured: 3 years
venous thromboembolism recurrence
total times
Measured: 3 years
major bleeding
total times
Measured: 3 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Jun 2017
- Study start15 Mar 2017
- Primary completion31 Dec 2020 (estimated)
- Study completion31 Dec 2020 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for COPDStudies of the same condition, open and under way.
- More trials run by Chinese Academy of Medical Sciences, Fuwai HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 1,708 participants (estimated)
- Target duration
- 3 Years
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Jianguo He, Chinese Academy of Medical Sciences, Fuwai Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03185377
- Sponsor's protocol ID
- 2016YFC1304402A
- Status last verified
- Jun 2017
- First submitted
- 11 Jun 2017
- Last updated
- 14 Jun 2017
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 14 Jun 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Study of Early Detection, Disease Course and Prognosis of Pulmonary Thromboembolism in Chronic Pulmonary Hypertension
- ClinicalTrials.gov ID
- NCT03185377
- Acronym / sponsor ID
- 2016YFC1304402A
- Conditions
- COPD, PTE - Pulmonary Thromboembolism
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 1,708 participants (estimated)
- Lead sponsor
- Chinese Academy of Medical Sciences, Fuwai HospitalUniversity, hospital or other
- Study start
- 15 Mar 2017 (actual)
- Primary completion
- 31 Dec 2020 (estimated)
- Study completion
- 31 Dec 2020 (estimated)
- First posted
- 14 Jun 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 3 Years
Who may qualify
- Ages
- 40 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- COPD patients
Key inclusion criteria (1 listed)
- Patients hospitalized for chronic obstructive pulmonary disease (COPD) exacerbation
Key exclusion criteria (5 listed)
- Stable COPD patients
- COPD hospitalized for definite causes other than pulmonary thromboembolism
- Patients with malignant tumor
- Patients with contraindications for CT pulmonary angiography
- Psychopath
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
All-cause mortality
Time frame: 3 years
mortality in %
3 secondary outcomes
COPD exacerbations
Time frame: 3 years
venous thromboembolism recurrence
Time frame: 3 years
major bleeding
Time frame: 3 years
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Jun 2017.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of COPD and PTE - Pulmonary Thromboembolism, run by Chinese Academy of Medical Sciences, Fuwai Hospital at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 14 Jun 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Yuanhua Yang, MD (13911773607, yyh1031@sina.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
All-cause mortality (time frame: 3 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Jun 2017.