To Assess the Long-term Risk for Adverse Events After PE.NCT01717092
Epidemiological Study of Chronic Thromboembolic Pulmonary Hypertension in China
An observational study of To Assess the Long-term Risk for Adverse Events After PE., run by Air Force Military Medical University, China at 2 sites in China.
Trial summary
Chronic thromboembolic pulmonary hypertension (CTPH) is associated with considerable morbidity and mortality. Its incidence after pulmonary embolism and associated risk factors are not well documented in Chinese population. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- To Assess the Long-term Risk for Adverse Events After PE.
- How many people
- 400 participants
- Where
- 2 sitesChina
- Study dates
- Oct 2012to Oct 2015
- 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 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Consecutive patients with an acute episode of pulmonary embolism but without prior venous thromboembolism.
Who may be able to join
- Patients with an episode of acute symptomatic pulmonary embolism without prior pulmonary embolism or venous thrombosis
Who cannot join
- Have other diseases (e.g., systemic sclerosis or severe emphysema) that could have caused nonthromboembolic pulmonary hypertension,
- Have preexisting exertional dyspnea,
- Geographically inaccessible for follow-up,
- Decline to participate in the study.
Trial locations and contacts
2 sites in 1 country.
China2 sites, 2 recruiting
- Recruiting
Tangdu hospital
Xi'an, Shaanxi, 710032
Yonghong Xie, MD, +86-29-84777725, xieyh65@yahoo.com.cn
- Recruiting
Xijing hospital
Xi'an, Shaanxi, 710032
Yongping Yu, MD, +86-29-84771132, yuyongping_6100@163.com
Yongping Yu, MD
About this study
Chronic thromboembolic pulmonary hypertension (CTPH) is associated with considerable morbidity and mortality. Its incidence after pulmonary embolism and associated risk factors are not well documented in Chinese population. We conducted a prospective, long-term, follow-up study to assess the incidence of symptomatic CTPH in consecutive patients with an acute episode of pulmonary embolism but without prior venous thromboembolism. Patients with unexplained persistent dyspnea during follow-up underwent transthoracic echocardiography and, if supportive findings were present, ventilation-perfusion lung scanning and pulmonary angiography. CTPH was considered to be present if systolic and mean pulmonary-artery pressures exceeded 40 mm Hg and 25 mm Hg, respectively; pulmonary-capillary wedge pressure was normal; and there was angiographic evidence of disease.
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 |
|---|---|---|
| Consecutive patients with acute PE | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
The cumulative incidence of symptomatic CTEPH
Measured: 2 years
Secondary outcomes (1)
Risk factors for Recurrent VTE and CTEPH
Measured: 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Oct 2012 (estimated)
- Study startOct 2012
- Primary completionOct 2015 (estimated)
- Study completionOct 2015 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for To Assess the Long-term Risk for Adverse Events After PE.Studies 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
- 400 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Air Force Military Medical University, China
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Shengqing Li, Air Force Military Medical University, China
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01717092
- Sponsor's protocol ID
- XJ-CTPH20121026
- Status last verified
- Feb 2014
- First submitted
- 26 Oct 2012
- Last updated
- 27 Feb 2014
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 27 Feb 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Epidemiological Study of Chronic Thromboembolic Pulmonary Hypertension in China
- ClinicalTrials.gov ID
- NCT01717092
- Acronym / sponsor ID
- XJ-CTPH20121026
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 400 participants (estimated)
- Lead sponsor
- Air Force Military Medical University, ChinaUniversity, hospital or other
- Study start
- Oct 2012
- Primary completion
- Oct 2015 (estimated)
- Study completion
- Oct 2015 (estimated)
- First posted
- 30 Oct 2012 (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.
Chronic thromboembolic pulmonary hypertension (CTPH) is associated with considerable morbidity and mortality. Its incidence after pulmonary embolism and associated risk factors are not well documented in Chinese population. We conducted a prospective, long-term, follow-up study to assess the incidence of symptomatic CTPH in consecutive patients with an acute episode of pulmonary embolism but without prior venous thromboembolism. Patients with unexplained persistent dyspnea during follow-up underwent transthoracic echocardiography and, if supportive findings were present, ventilation-perfusion lung scanning and pulmonary angiography. CTPH was considered to be present if systolic and mean pulmonary-artery pressures exceeded 40 mm Hg and 25 mm Hg, respectively; pulmonary-capillary wedge pressure was normal; and there was angiographic evidence of disease.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Consecutive patients with acute PE | – | – |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Consecutive patients with an acute episode of pulmonary embolism but without prior venous thromboembolism.
Key inclusion criteria (1 listed)
- Patients with an episode of acute symptomatic pulmonary embolism without prior pulmonary embolism or venous thrombosis
Key exclusion criteria (4 listed)
- Have other diseases (e.g., systemic sclerosis or severe emphysema) that could have caused nonthromboembolic pulmonary hypertension,
- Have preexisting exertional dyspnea,
- Geographically inaccessible for follow-up,
- Decline to participate in the study.
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 cumulative incidence of symptomatic CTEPH
Time frame: 2 years
1 secondary outcome
Risk factors for Recurrent VTE and CTEPH
Time frame: 2 years
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Feb 2014.
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.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of To Assess the Long-term Risk for Adverse Events After PE., run by Air Force Military Medical University, China at 2 sites 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 4 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 27 Feb 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites 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 Shengqing Li, MD, PhD (+86-29-84771132, shengqingli@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The cumulative incidence of symptomatic CTEPH (time frame: 2 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 27 Feb 2014.