Pulmonary Embolism and ThrombosisNCT05481242
An Observational Study About Adverse Outcomes in Acute Pulmonary Embolism Patients
An observational study of Pulmonary Embolism and Thrombosis and Deterioration, Clinical, run by Shengjing Hospital at 1 site in China.
Trial summary
This multi-center retrospective study collected clinical, laboratory, and CT pulmonary angiography parameters with acute pulmonary embolism patients from admission to predict adverse outcomes within 30 days after admission into hospital. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Pulmonary Embolism and Thrombosis, Deterioration, Clinical
- What is being tested?
- retrospective observational study
- How many people
- 2,000 participants
- Where
- 1 siteChina
- Study dates
- 1 Jan 2011to 31 Dec 2026
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Chinese
Who may be able to join
- age of ≥ 18 years and a pulmonary embolism diagnosis based on CT pulmonary angiography
Who cannot join
- pregnancy
- reception of reperfusion treatment before admission
- missing data regarding CT parameters, echocardiography, cardiac troponin I (c-Tn I), and N-terminal-pro brain natriuretic peptide (NT-pro BNP) levels.
Trial locations and contacts
1 site in 1 country.
About this study
This multi-center retrospective study collected clinical, laboratory, and CT pulmonary angiography parameters with acute pulmonary embolism patients from admission to predict adverse outcomes within 30 days after admission into hospital.
Read the detailed description
This multi-center retrospective study collected clinical, laboratory, and CT pulmonary angiography parameters with acute pulmonary embolism patients from admission to predict adverse outcomes within 30 days after admission into hospital.
Eligible patients were collected to develop and evaluate a simple predictive model for predicting the adverse outcomes. The discriminatory power was evaluated by comparing the nomogram to the established risk stratification systems. The consistency of the nomogram was evaluated using the validation cohort.
- Being tested
- retrospective observational study
- Medical subject headings
- Pulmonary Embolism, Thrombosis, Clinical Deterioration
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
retrospective observational studyOther
retrospective observational study
What is being measured
The primary outcome is the main question the study is designed to answer.
Adverse outcomes
The endpoints of deterioration in this study were defined as the occurrence of any adverse clinical outcomes from medical records and follow-up within 30 days of admission such as death, mechanical ventilation, cardiopulmonary resuscitation, and the need for life-saving vasopressor or reperfusion treatment .In each centre, the researchers for evaluating endpoints were blind to collect and to measure study parameters.
Measured: 30 days
Secondary outcomes (1)
Adverse outcomes
The endpoints of deterioration in this study were defined as the occurrence of any adverse clinical outcomes from medical records and follow-up within 2 years of admission such as death, mechanical ventilation, cardiopulmonary resuscitation, and the need for life-saving vasopressor or reperfusion treatment .In each centre, the researchers for evaluating endpoints were blind to collect and to measure study parameters.
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 posted1 Aug 2022
- Study start1 Jan 2011
- Primary completion31 Jan 2021
- Study completion31 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pulmonary Embolism and ThrombosisStudies of the same condition, open and under way.
- More trials run by Shengjing 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
- Retrospective
- Enrolment
- 2,000 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Shengjing Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, YIZHUO GAO, Shengjing Hospital
- Investigators
- DONG JIA, Principal investigator, Shenjing Hospital of CHINA MEDICAL UNIVERSITY
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05481242
- Sponsor's protocol ID
- AOAPE
- Status last verified
- Mar 2026
- First submitted
- 28 Jul 2022
- Last updated
- 11 Mar 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Observational Study About Adverse Outcomes in Acute Pulmonary Embolism Patients
- ClinicalTrials.gov ID
- NCT05481242
- Acronym / sponsor ID
- AOAPE
- Study type
- Observational
- Recruitment status
- Active, not recruiting
- Enrolment
- 2,000 participants (estimated)
- Lead sponsor
- Shengjing HospitalUniversity, hospital or other
- Study start
- 1 Jan 2011 (actual)
- Primary completion
- 31 Jan 2021 (actual)
- Study completion
- 31 Dec 2026 (estimated)
- First posted
- 1 Aug 2022 (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.
This multi-center retrospective study collected clinical, laboratory, and CT pulmonary angiography parameters with acute pulmonary embolism patients from admission to predict adverse outcomes within 30 days after admission into hospital.
Detailed description
This multi-center retrospective study collected clinical, laboratory, and CT pulmonary angiography parameters with acute pulmonary embolism patients from admission to predict adverse outcomes within 30 days after admission into hospital.
Eligible patients were collected to develop and evaluate a simple predictive model for predicting the adverse outcomes. The discriminatory power was evaluated by comparing the nomogram to the established risk stratification systems. The consistency of the nomogram was evaluated using the validation cohort.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Chinese
Key inclusion criteria (1 listed)
- age of ≥ 18 years and a pulmonary embolism diagnosis based on CT pulmonary angiography
Key exclusion criteria (3 listed)
- pregnancy
- reception of reperfusion treatment before admission
- missing data regarding CT parameters, echocardiography, cardiac troponin I (c-Tn I), and N-terminal-pro brain natriuretic peptide (NT-pro BNP) levels.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| retrospective observational studyretrospective observational study | Other | – |
Primary outcome
Adverse outcomes
Time frame: 30 days
The endpoints of deterioration in this study were defined as the occurrence of any adverse clinical outcomes from medical records and follow-up within 30 days of admission such as death, mechanical ventilation, cardiopulmonary resuscitation, and the need for life-saving vasopressor or reperfusion treatment .In each centre, the researchers for evaluating endpoints were blind to collect and to measure study parameters.
1 secondary outcome
Adverse outcomes
Time frame: 2 years
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Mar 2026.
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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.
DONG JIA principal investigator
Shenjing Hospital of CHINA MEDICAL UNIVERSITY
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 and Thrombosis and Deterioration, Clinical, run by Shengjing 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 3 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: under way, not looking for participants, as of the sponsor's last update on 11 Mar 2026. 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?
This study is still under way. Results are not available in the source record yet.
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?
Adverse outcomes (time frame: 30 days). 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 11 Mar 2026.