Pulmonary Embolism and ThrombosisNCT05098769
A Predictive Tool for Predicting Adverse Outcomes in Acute Pulmonary Embolism Patients Using CTPA.
An observational study of Pulmonary Embolism and Thrombosis and Deterioration, Clinical, run by Shengjing Hospital at 1 site in China.
Trial summary
This study collected clinical, laboratory, and CT parameters of acute patients with acute pulmonary embolism 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
- How many people
- 300 participants
- Where
- 1 siteChina
- Study dates
- 18 Jan 2021to 31 Dec 2026
- How long will I take part?
- 30 Days
- 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 PE 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. Contact the study team or a site near you to ask about taking part.
China1 site, 1 recruiting
- Recruiting
Shenjing Hospital of CHINA MEDICAL UNIVERSITY
Shenyang, Liaoning
YIZHUO GAO, +86-18940257523, gaoyizhuo.sy@hotmail.com
About this study
Official title: A Predictive Tool for Predicting Adverse Outcomes in Acute Pulmonary Embolism Patients Using Parameters Obtained by Computed Tomographic Pulmonary Angiography.
This study collected clinical, laboratory, and CT parameters of acute patients with acute pulmonary embolism from admission to predict adverse outcomes within 30 days after admission into hospital.
Read the detailed description
This study collected clinical, laboratory, and CT parameters of acute patients with acute pulmonary embolism from admission. The outcomes of interest were defined as the occurrence of adverse outcomes within 30 days after admission into hospital.
Eligible patients were randomized in some ratio into derivation and validation cohorts. The derivation cohort was used to develop and evaluate a multivariable logistic regression model for predicting the outcomes of interest. 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.
- Keywords
- Pulmonary Embolism and Thrombosis, Deterioration, Clinical
- 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.
| Study group | Role | What they receive |
|---|---|---|
| Acute pulmonary embolism | an age of ≥ 18 years and a PE diagnosis based on CT pulmonary angiography |
What is being measured
The primary outcome is the main question the study is designed to answer.
Adverse outcomes
The outcomes of interest were defined as the occurrence of adverse outcomes within 30 days after admission. Adverse outcomes were defined as PE-related deaths, the need for mechanical ventilation, the need for cardiopulmonary resuscitation, and the need for life-saving vasopressor and reperfusion treatment.
Measured: 7 days and 30 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Oct 2021
- Study start18 Jan 2021
- Primary completion31 Dec 2026 (estimated)
- Study completion31 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- 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
- Prospective
- Enrolment
- 300 participants (estimated)
- Target duration
- 30 Days
Sponsor and investigators
- Lead sponsor
- Shengjing Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, YIZHUO GAO, Shengjing Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05098769
- Sponsor's protocol ID
- AOAPECT
- Status last verified
- Mar 2026
- First submitted
- 16 Oct 2021
- Last updated
- 11 Mar 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Gao Y, Gu Z, Wei X, Wei S, Liu Y, Zhan S, Yang J, Qi C, Qi S, Wang M, Jia D. Ventricular septum curvature ratio: a novel imaging marker to predict clinical deterioration in normotensive acute pulmonary embolism. Crit Care. 2025 Oct 31;29(1):463. doi: 10.1186/s13054-025-05708-w.
PubMed 41174707Gao Y, Wei S, Liu Y, Yu Z, Zhan S, Yang B, Qi C, Qi S, Wang M, Jia D. Predicting Deterioration in Patients With Normotensive Acute Pulmonary Embolism Using Clinical-Imaging Features: A Multicenter Prospective Cohort Study. J Am Heart Assoc. 2025 Jul;14(13):e038984. doi: 10.1161/JAHA.124.038984. Epub 2025 Jun 27.
PubMed 40576035
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
- A Predictive Tool for Predicting Adverse Outcomes in Acute Pulmonary Embolism Patients Using Parameters Obtained by Computed Tomographic Pulmonary Angiography.
- ClinicalTrials.gov ID
- NCT05098769
- Acronym / sponsor ID
- AOAPECT
- Keywords
- Pulmonary Embolism and Thrombosis, Deterioration, Clinical
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 300 participants (estimated)
- Lead sponsor
- Shengjing HospitalUniversity, hospital or other
- Study start
- 18 Jan 2021 (actual)
- Primary completion
- 31 Dec 2026 (estimated)
- Study completion
- 31 Dec 2026 (estimated)
- First posted
- 28 Oct 2021 (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 study collected clinical, laboratory, and CT parameters of acute patients with acute pulmonary embolism from admission to predict adverse outcomes within 30 days after admission into hospital.
Detailed description
This study collected clinical, laboratory, and CT parameters of acute patients with acute pulmonary embolism from admission. The outcomes of interest were defined as the occurrence of adverse outcomes within 30 days after admission into hospital.
Eligible patients were randomized in some ratio into derivation and validation cohorts. The derivation cohort was used to develop and evaluate a multivariable logistic regression model for predicting the outcomes of interest. 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
- Prospective
- Target follow-up
- 30 Days
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Acute pulmonary embolism | – | –an age of ≥ 18 years and a PE diagnosis based on CT pulmonary angiography |
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 PE 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.
Primary outcome
Adverse outcomes
Time frame: 7 days and 30 days
The outcomes of interest were defined as the occurrence of adverse outcomes within 30 days after admission. Adverse outcomes were defined as PE-related deaths, the need for mechanical ventilation, the need for cardiopulmonary resuscitation, and the need for life-saving vasopressor and reperfusion treatment.
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.
- Derived from this study: PubMed 41174707Gao Y, Gu Z, Wei X, Wei S, Liu Y, Zhan S, Yang J, Qi C, Qi S, Wang M, Jia D. Ventricular septum curvature ratio: a novel imaging marker to predict clinical deterioration in normotensive acute pulmonary embolism. Crit Care. 2025 Oct 31;29(1):463. doi: 10.1186/s13054-025-05708-w.
- Derived from this study: PubMed 40576035Gao Y, Wei S, Liu Y, Yu Z, Zhan S, Yang B, Qi C, Qi S, Wang M, Jia D. Predicting Deterioration in Patients With Normotensive Acute Pulmonary Embolism Using Clinical-Imaging Features: A Multicenter Prospective Cohort Study. J Am Heart Assoc. 2025 Jul;14(13):e038984. doi: 10.1161/JAHA.124.038984. Epub 2025 Jun 27.
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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.
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: looking for participants now, 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?
Contact YIZHUO GAO (+86-18940257523, gaoyizhuo.sy@hotmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Adverse outcomes (time frame: 7 days and 30 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05098769, which also lists 2 linked publications.
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; AzTrials last refreshed its copy on 2 Nov 2026.