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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT05098769
Other study ID # AOAPECT
Secondary ID
Status Recruiting
Phase
First received
Last updated
Start date January 18, 2021
Est. completion date December 31, 2025

Study information

Verified date October 2023
Source Shengjing Hospital
Contact YIZHUO GAO
Phone +86-18940257523
Email gaoyizhuo.sy@hotmail.com
Is FDA regulated No
Health authority
Study type Observational [Patient Registry]

Clinical Trial Summary

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.


Description:

This study collected clinical, laboratory, and CT parameters of acute patients with acute pulmonary embolism 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.


Recruitment information / eligibility

Status Recruiting
Enrollment 300
Est. completion date December 31, 2025
Est. primary completion date December 31, 2025
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility 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.

Study Design


Related Conditions & MeSH terms


Locations

Country Name City State
China Shenjing Hospital of CHINA MEDICAL UNIVERSITY 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 Adverse outcomes 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. 30 days
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