A Predictive Tool for Predicting Adverse Outcomes in Acute Pulmonary Embolism Patients Using CTPA.

Sponsor

Shengjing Hospital (Other)

Overall Status

Recruiting

CT.gov ID

NCT05098769

Collaborator

(none)

300

Enrollment

Location

59.4

Anticipated Duration (Months)

5.1

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

This study collected clinical, laboratory, and CT parameters of acute patients with acute PE from admission to predict adverse outcomes within 30 days after admission into hospital.

Condition or Disease	Intervention/Treatment	Phase
Pulmonary Embolism and Thrombosis Deterioration, Clinical

Detailed Description

This study collected clinical, laboratory, and CT parameters of acute patients with acute PE from admission. The outcomes of interest were defined as the occurrence of adverse outcomes within 30 days after admission into hospital.

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 Design

Study Type:

Observational [Patient Registry]

Anticipated Enrollment :

300 participants

Observational Model:

Cohort

Time Perspective:

Prospective

Official Title:

A Predictive Tool for Predicting Adverse Outcomes in Acute Pulmonary Embolism Patients Using Parameters Obtained by Computed Tomographic Pulmonary Angiography.

Actual Study Start Date :

Jan 18, 2021

Anticipated Primary Completion Date :

Dec 31, 2025

Anticipated Study Completion Date :

Dec 31, 2025

Arms and Interventions

Arm	Intervention/Treatment
Acute pulmonary embolism an age of ≥ 18 years and a PE diagnosis based on CT pulmonary angiography

Outcome Measures

Primary Outcome Measures

Adeverse outcomes [30 days]
The outcomes of interest were defined as the occurrence of adverse outcomes within 30 days after admission. Adverse outcomes were defined as PE-related deaths, the need for mechanical ventilation, the need for cardiopulmonary resuscitation, and the need for life-saving vasopressor and reperfusion treatment.

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Inclusion Criteria:

age of ≥ 18 years and a PE 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.