Early Systolic Notching in Pulmonary Embolism
Diagnostic Accuracy of Early Systolic Notching in Pulmonary Embolism
1 other identifier
observational
180
1 country
1
Brief Summary
Venous thromboembolism (VTE), clinically seen as deep vein thrombosis (DVT) or pulmonary embolism (PE), is the third most common acute cardiovascular syndrome after myocardial infarction and stroke. In a study conducted by critical care and emergency physicians, lung ultrasonography (US) for pleural infarction areas, lower extremity venous US in terms of DVT, and focused cardiac US in terms of right ventricular strain were demonstrated with different diagnostic values for PE. However, no ultrasonographic method alone has a high diagnostic value for PE alone in the literature. In a recent study, it is stated that a new cardiac finding (early systolic notch- ESN) has high sensitivity (92%) and specificity (99%) in massive and submassive emboli. However, the limited patient population and the exclusion of many patient groups limits the applicability of the study and its use in other patient groups. With this study, it was aimed to determine the diagnostic value of ESN finding within the emergency department conditions by keeping the patient population wider.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for all trials
Started Jun 2020
Shorter than P25 for all trials
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
May 29, 2020
CompletedFirst Posted
Study publicly available on registry
June 4, 2020
CompletedStudy Start
First participant enrolled
June 15, 2020
CompletedPrimary Completion
Last participant's last visit for primary outcome
January 15, 2021
CompletedStudy Completion
Last participant's last visit for all outcomes
January 15, 2021
CompletedFebruary 3, 2021
February 1, 2021
7 months
May 29, 2020
February 1, 2021
Conditions
Outcome Measures
Primary Outcomes (1)
To determine the diagnostic accuracy of the ESN finding
What is the diagnostic value of ESN finding in patients with PE diagnosed with pulmonary CT angio?
6 months
Eligibility Criteria
Patients who presented to the emergency department and underwent pulmonary CT angio imaging with suspicion of pulmonary embolism.
You may qualify if:
- Patients undergoing pulmonary CT angiography with suspicion of pulmonary embolism
You may not qualify if:
- Pregnant women,
- Patients under 18 years of age,
- Those who received thrombolytic therapy,
- Poor ultrasound imaging.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Gazi Universitylead
- Akdeniz Universitycollaborator
- Ege Universitycollaborator
- Antalya Training and Research Hospitalcollaborator
- Rize Üniversitesicollaborator
- Izmir Katip Celebi Universitycollaborator
Study Sites (1)
Gazi University Facaulty of Medicine
Ankara, Turkey (Türkiye)
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Assos. Prof.
Study Record Dates
First Submitted
May 29, 2020
First Posted
June 4, 2020
Study Start
June 15, 2020
Primary Completion
January 15, 2021
Study Completion
January 15, 2021
Last Updated
February 3, 2021
Record last verified: 2021-02