An Observational Study About Adverse Outcomes in Acute Pulmonary Embolism Patients

Active, not recruiting

• Conditions: Pulmonary Embolism and Thrombosis; Deterioration, Clinical

• Registration Number: NCT05481242
• Lead Sponsor: Shengjing Hospital

Brief Summary

This multi-center retrospective study collected clinical, laboratory, and CT pulmonary angiography parameters with acute pulmonary embolism patients from admission to predict adverse outcomes within 30 days after admission into hospital.

Detailed Description

This multi-center retrospective study collected clinical, laboratory, and CT pulmonary angiography parameters with acute pulmonary embolism patients from admission to predict adverse outcomes within 30 days after admission into hospital.

Eligible patients were collected to develop and evaluate a simple predictive model for predicting the adverse outcomes. 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
• Primary Completion: 2021-01-31
• Study First Submitted: 2022-07-28
• Study First Submitted QC: 2022-07-29
• Study First Posted: 2022-08-01
• Status Verified: 2023-11
• Last Update Submitted: 2023-11-01
• Last Update Posted: 2023-11-03
• Study Completion: 2025-12-31

Recruitment & Eligibility

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

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

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Adverse outcomes	30 days	The endpoints of deterioration in this study were defined as the occurrence of any adverse clinical outcomes from medical records and follow-up within 30 days of admission such as death, mechanical ventilation, cardiopulmonary resuscitation, and the need for life-saving vasopressor or reperfusion treatment .In each centre, the researchers for evaluating endpoints were blind to collect and to measure study parameters.

Secondary Outcome Measures

Name	Time	Method
Adverse outcomes	2 years	The endpoints of deterioration in this study were defined as the occurrence of any adverse clinical outcomes from medical records and follow-up within 2 years of admission such as death, mechanical ventilation, cardiopulmonary resuscitation, and the need for life-saving vasopressor or reperfusion treatment .In each centre, the researchers for evaluating endpoints were blind to collect and to measure study parameters.

Trial Locations

Locations (1)

Shenjing Hospital of CHINA MEDICAL UNIVERSITY; 🇨🇳 Shenyang, Liaoning, China