Pulmonary EmbolismNCT05723003
Prospective Validation of an Acute Pulmonary Embolism Severity and Prognosis Prediction Model
An observational study of Pulmonary Embolism, run by Peking Union Medical College Hospital at 1 site in China.
Trial summary
The purpose of this study is to prospectively validate the first PUMCH model for acute PE severity and prognosis prediction based on multi-center data constructed in the pre-project period based on national population data, and to optimize the PUMCH model based on artificial intelligence clustering algorithm. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Pulmonary Embolism
- How many people
- 4,000 participants
- Where
- 1 siteChina
- Study dates
- 1 Feb 2023to 30 Oct 2025
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Inpatients with acute PTE diagnosed by imaging (CTPA, enhanced CT, V/Q imaging suggesting a high probability of PE, pulmonary angiography, MRPA).
Who may be able to join
- age ≥ 18 years
- Inpatients with acute PTE diagnosed by imaging (CTPA, enhanced CT, V/Q imaging suggesting a high probability of PE, pulmonary angiography, MRPA) containing any of the following conditions.
- primary acute PTE combined with or without DVT
- recurrent acute PTE with a history of previous PTE or DVT
- signed informed consent form
Who cannot join
- blinded to any diagnostic or therapeutic test (VTE or other conditions)
- unable to complete follow-up (due to cognitive or behavioral limitations, etc.)
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Peking Union Medical College Hospital
Beijing, Beijing Municipality, 100730
Juhong Shi, M.D, +8613701178492, shijh@pumch.cn
About this study
Official title: Multicenter Prospective Validation and Extension of the 'PUMCH' Acute Pulmonary Embolism Severity and Prognosis Prediction Model
The purpose of this study is to prospectively validate the first PUMCH model for acute PE severity and prognosis prediction based on multi-center data constructed in the pre-project period based on national population data, and to optimize the PUMCH model based on artificial intelligence clustering algorithm.
Read the detailed description
Patients with pulmonary embolism and aged 18 years or older were enrolled in this study.Patient demographic characteristics(age, sex, department, diagnosis), basic vital signs, symptoms at their admissions (hemoptysis, dyspnea, chest pain, syncope, laboratory examinations (blood lab routines, blood gas, liver and kidney function, myocardial marker), and imaging examinations (vascular ultrasonography, computed tomographic angiography, echocardiography, chest CT,CTPA, pulmonary perfusion imaging, pulmonary angiography, PET/CT) were prospectively collected. Patients were followed up every 1/3/6 months to obtain survival outcomes.
- Conditions
- Pulmonary Embolism
- Keywords
- Pulmonary Embolism, Prognosis assessment model
- Medical subject headings
- Pulmonary Embolism
What is being measured
The primary outcome is the main question the study is designed to answer.
All-cause mortality
all-cause mortality 30 days after diagnosis of acute symptomatic PE.
Measured: through study completion, an average of 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Feb 2023
- Study start1 Feb 2023 (estimated)
- Primary completion1 Jan 2025 (estimated)
- Study completion30 Oct 2025 (estimated)
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.
- More trials run by Peking Union Medical College 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
- 4,000 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Peking Union Medical College Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Juhong Shi, M.D, Principal investigator, Peking Union Medical College Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05723003
- Sponsor's protocol ID
- PUMCHrule
- Status last verified
- Jan 2023
- First submitted
- 9 Jan 2023
- Last updated
- 10 Feb 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 Feb 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Multicenter Prospective Validation and Extension of the 'PUMCH' Acute Pulmonary Embolism Severity and Prognosis Prediction Model
- ClinicalTrials.gov ID
- NCT05723003
- Acronym / sponsor ID
- PUMCHrule
- Conditions
- Pulmonary Embolism
- Keywords
- Pulmonary Embolism, Prognosis assessment model
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 4,000 participants (estimated)
- Lead sponsor
- Peking Union Medical College HospitalUniversity, hospital or other
- Study start
- 1 Feb 2023 (estimated)
- Primary completion
- 1 Jan 2025 (estimated)
- Study completion
- 30 Oct 2025 (estimated)
- First posted
- 10 Feb 2023 (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.
The purpose of this study is to prospectively validate the first PUMCH model for acute PE severity and prognosis prediction based on multi-center data constructed in the pre-project period based on national population data, and to optimize the PUMCH model based on artificial intelligence clustering algorithm.
Detailed description
Patients with pulmonary embolism and aged 18 years or older were enrolled in this study.Patient demographic characteristics(age, sex, department, diagnosis), basic vital signs, symptoms at their admissions (hemoptysis, dyspnea, chest pain, syncope, laboratory examinations (blood lab routines, blood gas, liver and kidney function, myocardial marker), and imaging examinations (vascular ultrasonography, computed tomographic angiography, echocardiography, chest CT,CTPA, pulmonary perfusion imaging, pulmonary angiography, PET/CT) were prospectively collected. Patients were followed up every 1/3/6 months to obtain survival outcomes.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Inpatients with acute PTE diagnosed by imaging (CTPA, enhanced CT, V/Q imaging suggesting a high probability of PE, pulmonary angiography, MRPA).
Key inclusion criteria (5 listed)
- age ≥ 18 years
- Inpatients with acute PTE diagnosed by imaging (CTPA, enhanced CT, V/Q imaging suggesting a high probability of PE, pulmonary angiography, MRPA) containing any of the following conditions.
- signed informed consent form
Key exclusion criteria (2 listed)
- blinded to any diagnostic or therapeutic test (VTE or other conditions)
- unable to complete follow-up (due to cognitive or behavioral limitations, etc.)
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: through study completion, an average of 1 year
all-cause mortality 30 days after diagnosis of acute symptomatic PE.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Feb 2023.
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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.
Juhong Shi, M.D principal investigator
Peking Union Medical College Hospital
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 Peking Union Medical College 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 5 inclusion and 2 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 10 Feb 2023. 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 Juhong Shi, M.D (+8613701178492, shijh@pumch.cn), 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: through study completion, an average of 1 year). 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 10 Feb 2023.