- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05481242
An Observational Study About Adverse Outcomes in Acute Pulmonary Embolism Patients
Study Overview
Status
Intervention / Treatment
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
Enrollment (Estimated)
Contacts and Locations
Study Locations
-
-
Liaoning
-
Shenyang, Liaoning, China
- Shenjing Hospital of CHINA MEDICAL UNIVERSITY
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Sampling Method
Study Population
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
Time Frame: 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.
|
30 days
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Adverse outcomes
Time Frame: 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.
|
2 years
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: DONG JIA, Shenjing Hospital of CHINA MEDICAL UNIVERSITY
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- AOAPE
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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