Adverse Outcome of Acute Pulmonary Embolism by Artificial Intelligence System Based on CT Pulmonary Angiography

Recruiting

• Conditions: Deterioration, Clinical; Pulmonary Embolism and Thrombosis; Artificial Intelligence

• Registration Number: NCT05482269
• Lead Sponsor: Shengjing Hospital

Brief 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.

Detailed 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.

Study Timeline

• Study Start: 2011-01-01
• Study First Submitted: 2022-07-29
• Study First Submitted QC: 2022-07-29
• Primary Completion: 2022-07-31
• Study First Posted: 2022-08-01
• Status Verified: 2023-11
• Last Update Submitted: 2023-11-01
• Last Update Posted: 2023-11-02
• Study Completion: 2025-12-31

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 2000

Inclusion Criteria

• age of ≥ 18 years and a pulmonary embolism diagnosis based on CT pulmonary angiography

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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.

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Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Incidence of Treatment-Emergent Adverse Events	30 days	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.

Secondary Outcome Measures

Name	Time	Method
Incidence of Treatment-Emergent Adverse Events	2 years	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.

Trial Locations

Locations (1)

Shengjing Hospital; 🇨🇳 Shenyang, Liaoning, China