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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT05482269
Other study ID # PEAICTPA
Secondary ID
Status Recruiting
Phase
First received
Last updated
Start date January 1, 2011
Est. completion date December 31, 2025

Study information

Verified date November 2023
Source Shengjing Hospital
Contact DONG JIA
Phone +86-18940252800
Email jiadong0101@126.com
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

The investigators aim to build a predictive tool for Adverse Outcome of Acute Pulmonary Embolism by Artificial Intelligence System Based on CT Pulmonary Angiography.


Description:

This study collected clinical, laboratory, and CT parameters of acute patients with acute pulmonary embolism from admission to predict adverse outcomes within 30 days after admission into hospital. The investigators aim to build a predictive tool for Adverse Outcome of Acute Pulmonary Embolism by Artificial Intelligence System Based on CT Pulmonary Angiography. Eligible patients were randomized in some ratio into derivation and validation cohorts. The derivation cohort was used to develop and evaluate a multivariable logistic regression model for predicting the outcomes of interest. The discriminatory power was evaluated by comparing the nomogram to the established risk stratification systems. The consistency of the nomogram was evaluated using the validation cohort.


Recruitment information / eligibility

Status Recruiting
Enrollment 2000
Est. completion date December 31, 2025
Est. primary completion date July 31, 2022
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility Inclusion Criteria: - age of = 18 years and a pulmonary embolism diagnosis based on CT pulmonary angiography Exclusion Criteria: - pregnancy - reception of reperfusion treatment before admission - missing data regarding CT parameters, echocardiography, cardiac troponin I (c-Tn I), and N-terminal-pro brain natriuretic peptide (NT-pro BNP) levels.

Study Design


Intervention

Other:
no intervention
no intervention

Locations

Country Name City State
China Shengjing Hospital Shenyang Liaoning

Sponsors (1)

Lead Sponsor Collaborator
Shengjing Hospital

Country where clinical trial is conducted

China, 

Outcome

Type Measure Description Time frame Safety issue
Primary Incidence of Treatment-Emergent Adverse Events The outcomes of interest were defined as the occurrence of adverse outcomes within 30 days after admission. Adverse outcomes were defined as deaths, the need for mechanical ventilation, the need for cardiopulmonary resuscitation, and the need for life-saving vasopressor and reperfusion treatment. 30 days
Secondary Incidence of Treatment-Emergent Adverse Events The outcomes of interest were defined as the occurrence of adverse outcomes within 2 years after admission. Adverse outcomes were defined as deaths, the need for mechanical ventilation, the need for cardiopulmonary resuscitation, and the need for life-saving vasopressor and reperfusion treatment. 2 years
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