Pulmonary EmbolismNCT02214043
Clinical Characteristics of Acute Pulmonary Embolism in Chinese Population
An observational study of Pulmonary Embolism, run by Chinese Pulmonary Vascular Disease Research Group at 1 site in China.
Trial summary
There are no special clinical characteristics of acute pulmonary embolism in Chinese population. Read more about this study
- Who is it for?
- Ages 15 to 85 years
- Conditions the study is for
- Pulmonary Embolism
- How many people
- 600 participants
- Where
- 1 siteChina
- Study dates
- Jan 2012to Dec 2017
- How long will I take part?
- 5 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 15 to 85 years
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: Acute pulmonary embolism in Chinese population
Who may be able to join
- the symptomatic acute PE confirmed by objective examination
Who cannot join
- congestive heart failure
- chronic obstructive pulmonary disease;
- a prior documented episode of PE or DVT
- renal dysfunction;
- a life expectancy of less than 6 months
Trial locations and contacts
1 site in 1 country.
About this study
There are no special clinical characteristics of acute pulmonary embolism in Chinese population.
- Conditions
- Pulmonary Embolism
- Medical subject headings
- Pulmonary Embolism
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Group 2 | Not described | |
| group 1 | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
The primary end point of the present study was symptomatic, objectively confirmed recurrent fatal or nonfatal VTE.
Measured: 60 months
Secondary outcomes (1)
The second end point was death (all cause death and PE-related death).
If the participant died, the relatives need provided the written medical record on the death.
Measured: 60 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Aug 2014 (estimated)
- Study startJan 2012
- Primary completionDec 2017
- Study completionDec 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pulmonary EmbolismStudies of the same condition, open and under way.
- 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
- 600 participants (actual)
- Target duration
- 5 Years
Sponsor and investigators
- Lead sponsor
- Chinese Pulmonary Vascular Disease Research Group
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Zhihong Liu, Doctor, Study chair, Chinese pulmonary vascular disease organization group
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02214043
- Sponsor's protocol ID
- APEINCP
- Status last verified
- Jul 2016
- First submitted
- 3 Feb 2014
- Last updated
- 30 Jan 2018
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 30 Jan 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Characteristics of Acute Pulmonary Embolism in Chinese Population
- ClinicalTrials.gov ID
- NCT02214043
- Acronym / sponsor ID
- APEINCP
- Conditions
- Pulmonary Embolism
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 600 participants (actual)
- Lead sponsor
- Chinese Pulmonary Vascular Disease Research GroupUniversity, hospital or other
- Study start
- Jan 2012
- Primary completion
- Dec 2017 (actual)
- Study completion
- Dec 2017 (actual)
- First posted
- 12 Aug 2014 (estimated)
- 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.
There are no special clinical characteristics of acute pulmonary embolism in Chinese population.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 5 Years
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Group 2 | – | – |
| group 1 | – | – |
Who may qualify
- Ages
- 15 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Acute pulmonary embolism in Chinese population
Key inclusion criteria (1 listed)
- the symptomatic acute PE confirmed by objective examination
Key exclusion criteria (5 listed)
- congestive heart failure
- chronic obstructive pulmonary disease;
- a prior documented episode of PE or DVT
- renal dysfunction;
- a life expectancy of less than 6 months
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
The primary end point of the present study was symptomatic, objectively confirmed recurrent fatal or nonfatal VTE.
Time frame: 60 months
1 secondary outcome
The second end point was death (all cause death and PE-related death).
Time frame: 60 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Jan 2018.
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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.
Zhihong Liu, Doctor study chair
Chinese pulmonary vascular disease organization group
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 Pulmonary Embolism, run by Chinese Pulmonary Vascular Disease Research Group 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: finished, as of the sponsor's last update on 30 Jan 2018. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The primary end point of the present study was symptomatic, objectively confirmed recurrent fatal or nonfatal VTE. (time frame: 60 months). 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 30 Jan 2018.