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

Pulmonary Embolism Clinical Trial

Official title:

Multicenter Prospective Validation and Extension of the 'PUMCH' Acute Pulmonary Embolism Severity and Prognosis Prediction Model

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05723003
• Other study ID #: PUMCHrule
• Status: Recruiting
• Start date: February 1, 2023
• Est. completion date: October 30, 2025

Study information

• Verified date: January 2023
• Source: Peking Union Medical College Hospital
• Contact: Juhong Shi, M.D
• Phone: +8613701178492
• Email: shijh[@]pumch.cn
• Is FDA regulated: No
• Study type: Observational

Clinical 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 4000
• Est. completion date: October 30, 2025
• Est. primary completion date: January 1, 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.)

Related Conditions & MeSH terms

• Embolism
• Pulmonary Embolism

Locations

Country	Name	City	State
China	Peking Union Medical College Hospital	Beijing	Beijing

Sponsors (1)

Lead Sponsor	Collaborator
Peking Union Medical College Hospital

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	All-cause mortality	all-cause mortality 30 days after diagnosis of acute symptomatic PE.	through study completion, an average of 1 year