NCT05723003

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
4,000

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Feb 2023

Typical duration for all trials

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

January 9, 2023

Completed
23 days until next milestone

Study Start

First participant enrolled

February 1, 2023

Completed
9 days until next milestone

First Posted

Study publicly available on registry

February 10, 2023

Completed
1.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2025

Completed
10 months until next milestone

Study Completion

Last participant's last visit for all outcomes

October 30, 2025

Completed
Last Updated

February 10, 2023

Status Verified

January 1, 2023

Enrollment Period

1.9 years

First QC Date

January 9, 2023

Last Update Submit

February 1, 2023

Conditions

Pulmonary Embolism

Keywords

Pulmonary EmbolismPrognosis assessment model

Outcome Measures

Primary Outcomes (1)

  • All-cause mortality

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

    through study completion, an average of 1 year

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Inpatients with acute PTE diagnosed by imaging (CTPA, enhanced CT, V/Q imaging suggesting a high probability of PE, pulmonary angiography, MRPA).

You may qualify if:

  • 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

You may not qualify if:

  • blinded to any diagnostic or therapeutic test (VTE or other conditions)
  • unable to complete follow-up (due to cognitive or behavioral limitations, etc.)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Peking Union Medical College Hospital

Beijing, Beijing Municipality, 100730, China

RECRUITING

MeSH Terms

Conditions

Pulmonary Embolism

Condition Hierarchy (Ancestors)

Lung DiseasesRespiratory Tract DiseasesEmbolismEmbolism and ThrombosisVascular DiseasesCardiovascular Diseases

Study Officials

  • Juhong Shi, M.D

    Peking Union Medical College Hospital

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Juhong Shi, M.D

CONTACT

+8613701178492shijh@pumch.cn

Min Peng, M.D

CONTACT

+8613581888792pengmin@pumch.cn

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 9, 2023

First Posted

February 10, 2023

Study Start

February 1, 2023

Primary Completion

January 1, 2025

Study Completion

October 30, 2025

Last Updated

February 10, 2023

Record last verified: 2023-01

Locations

CN(1)