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Prospective Validation of an Acute Pulmonary Embolism Severity and Prognosis Prediction Model

Sponsor
Peking Union Medical College Hospital (Other)
Overall Status
Recruiting
CT.gov ID
NCT05723003
Collaborator
(none)
4,000
Enrollment
1
Location
32.9
Anticipated Duration (Months)
121.5
Patients Per Site Per Month

Study Details

Study Description

Brief 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.

Condition or Disease Intervention/Treatment Phase

    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

    Study Type:
    Observational
    Anticipated Enrollment :
    4000 participants
    Observational Model:
    Cohort
    Time Perspective:
    Prospective
    Official Title:
    Multicenter Prospective Validation and Extension of the 'PUMCH' Acute Pulmonary Embolism Severity and Prognosis Prediction Model
    Anticipated Study Start Date :
    Feb 1, 2023
    Anticipated Primary Completion Date :
    Jan 1, 2025
    Anticipated Study Completion Date :
    Oct 30, 2025

    Outcome Measures

    Primary Outcome Measures

    1. All-cause mortality [through study completion, an average of 1 year]

      all-cause mortality 30 days after diagnosis of acute symptomatic PE.

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    Inclusion Criteria:

    • 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.

    1. primary acute PTE combined with or without DVT

    2. recurrent acute PTE with a history of previous PTE or DVT

    • signed informed consent form
    Exclusion Criteria:

    • blinded to any diagnostic or therapeutic test (VTE or other conditions)

    • unable to complete follow-up (due to cognitive or behavioral limitations, etc.)

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Peking Union Medical College Hospital Beijing Beijing China 100730

    Sponsors and Collaborators

    • Peking Union Medical College Hospital

    Investigators

    • Principal Investigator: Juhong Shi, M.D, Peking Union Medical College Hospital

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Peking Union Medical College Hospital
    ClinicalTrials.gov Identifier:
    NCT05723003
    Other Study ID Numbers:
    • PUMCHrule
    First Posted:
    Feb 10, 2023
    Last Update Posted:
    Feb 10, 2023
    Last Verified:
    Jan 1, 2023
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Keywords provided by Peking Union Medical College Hospital
    Pulmonary Embolism
    Prognosis assessment model
    Additional relevant MeSH terms:
    Pulmonary Embolism
    Embolism

    Study Results

    No Results Posted as of Feb 10, 2023