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

Recruiting

• Conditions: Pulmonary Embolism

• Registration Number: NCT05723003
• Lead Sponsor: Peking Union Medical College Hospital

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.

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 Timeline

• Status Verified: 2023-01
• Study First Submitted: 2023-01-09
• Study Start: 2023-02-01
• Study First Submitted QC: 2023-02-01
• Last Update Submitted: 2023-02-01
• Study First Posted: 2023-02-10
• Last Update Posted: 2023-02-10
• Primary Completion: 2025-01-01
• Study Completion: 2025-10-30

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 4000

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.)

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
All-cause mortality	through study completion, an average of 1 year	all-cause mortality 30 days after diagnosis of acute symptomatic PE.

Trial Locations

Locations (1)

Peking Union Medical College Hospital; 🇨🇳 Beijing, Beijing, China