Early Systolic Notching in Pulmonary Embolism

Pulmonary Embolism Clinical Trial

Official title:

Diagnostic Accuracy of Early Systolic Notching in Pulmonary Embolism

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04413825
• Other study ID #: Gazi U.
• Status: Completed
• Start date: June 15, 2020
• Est. completion date: January 15, 2021

Study information

• Verified date: February 2021
• Source: Gazi University
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 180
• Est. completion date: January 15, 2021
• Est. primary completion date: January 15, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Patients undergoing pulmonary CT angiography with suspicion of pulmonary embolism

Exclusion Criteria:

• Pregnant women,

• Patients under 18 years of age,

• Those who received thrombolytic therapy,

• Poor ultrasound imaging.

Related Conditions & MeSH terms

• Embolism
• Pulmonary Embolism

Locations

Country	Name	City	State
Turkey	Gazi University Facaulty of Medicine	Ankara

Sponsors (6)

Lead Sponsor	Collaborator
Gazi University	Akdeniz University, Antalya Training and Research Hospital, Ege University, Izmir Katip Celebi University, Rize Üniversitesi

Country where clinical trial is conducted

Turkey, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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