An Observational Study About Adverse Outcomes in Acute Pulmonary Embolism Patients

Pulmonary Embolism and Thrombosis Clinical Trial

Official title:

An Observational Study About Adverse Outcomes in Acute Pulmonary Embolism Patients

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT05481242
• Other study ID #: AOAPE
• Status: Active, not recruiting
• Start date: January 1, 2011
• Est. completion date: December 31, 2025

Study information

• Verified date: November 2023
• Source: Shengjing Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 2000
• Est. completion date: December 31, 2025
• Est. primary completion date: January 31, 2021
• 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.

Related Conditions & MeSH terms

• Clinical Deterioration
• Deterioration, Clinical
• Embolism
• Embolism and Thrombosis
• Pulmonary Embolism
• Pulmonary Embolism and Thrombosis
• Thrombosis

Intervention

Other:
• retrospective observational study
retrospective observational study

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 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.	30 days
Secondary	Adverse outcomes	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.	2 years