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Early Systolic Notching in Pulmonary Embolism

Sponsor
Gazi University (Other)
Overall Status
Completed
CT.gov ID
NCT04413825
Collaborator
Akdeniz University (Other), Ege University (Other), Antalya Training and Research Hospital (Other), Rize Üniversitesi (Other), Izmir Katip Celebi University (Other)
180
Enrollment
1
Location
7
Actual Duration (Months)
25.6
Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase

    Study Design

    Study Type:
    Observational
    Actual Enrollment :
    180 participants
    Observational Model:
    Cohort
    Time Perspective:
    Prospective
    Official Title:
    Diagnostic Accuracy of Early Systolic Notching in Pulmonary Embolism
    Actual Study Start Date :
    Jun 15, 2020
    Actual Primary Completion Date :
    Jan 15, 2021
    Actual Study Completion Date :
    Jan 15, 2021

    Outcome Measures

    Primary Outcome Measures

    1. To determine the diagnostic accuracy of the ESN finding [6 months]

      What is the diagnostic value of ESN finding in patients with PE diagnosed with pulmonary CT angio?

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    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.

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Gazi University Facaulty of Medicine Ankara Turkey

    Sponsors and Collaborators

    • Gazi University
    • Akdeniz University
    • Ege University
    • Antalya Training and Research Hospital
    • Rize Üniversitesi
    • Izmir Katip Celebi University

    Investigators

    None specified.

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Mehmet Ali Aslaner, Assos. Prof., Gazi University
    ClinicalTrials.gov Identifier:
    NCT04413825
    Other Study ID Numbers:
    • Gazi U.
    First Posted:
    Jun 4, 2020
    Last Update Posted:
    Feb 3, 2021
    Last Verified:
    Feb 1, 2021
    Individual Participant Data (IPD) Sharing Statement:
    Undecided
    Plan to Share IPD:
    Undecided
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Additional relevant MeSH terms:
    Pulmonary Embolism
    Embolism

    Study Results

    No Results Posted as of Feb 3, 2021