An Observational Study About Adverse Outcomes in Acute Pulmonary Embolism Patients

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.

Study Overview

• Status: Active, not recruiting
• Conditions: Pulmonary Embolism and Thrombosis; Deterioration, Clinical
• Intervention / Treatment: Other: retrospective observational study

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 Type: Observational
• Enrollment (Estimated): 2000

Contacts and Locations

Study Locations

• China
  • Liaoning
    • Shenyang, Liaoning, China
      • Shenjing Hospital of China Medical University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

• Sampling Method: Probability Sample

Study Population

Chinese

Description

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 Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Retrospective

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Collaborators and Investigators

• Sponsor: Shengjing Hospital
• Investigators: Principal Investigator: DONG JIA, Shenjing Hospital of China Medical University

Study record dates

Study Major Dates

• Study Start (Actual): January 1, 2011
• Primary Completion (Actual): January 31, 2021
• Study Completion (Estimated): December 31, 2026

Study Registration Dates

• First Submitted: July 28, 2022
• First Submitted That Met QC Criteria: July 29, 2022
• First Posted (Actual): August 1, 2022

Study Record Updates

• Last Update Posted (Actual): March 11, 2026
• Last Update Submitted That Met QC Criteria: March 8, 2026
• Last Verified: March 1, 2026

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Vascular Diseases; Cardiovascular Diseases; Pathologic Processes; Disease Attributes; Respiratory Tract Diseases; Lung Diseases; Embolism and Thrombosis; Embolism; Disease Progression; Pathological Conditions, Signs and Symptoms; Clinical Deterioration; Pulmonary Embolism; Thrombosis
• Other Study ID Numbers: AOAPE

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No