NCT04413825

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

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
180

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Jun 2020

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

May 29, 2020

Completed
6 days until next milestone

First Posted

Study publicly available on registry

June 4, 2020

Completed
11 days until next milestone

Study Start

First participant enrolled

June 15, 2020

Completed
7 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 15, 2021

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 15, 2021

Completed
Last Updated

February 3, 2021

Status Verified

February 1, 2021

Enrollment Period

7 months

First QC Date

May 29, 2020

Last Update Submit

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

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

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

Study Sites (1)

Gazi University Facaulty of Medicine

Ankara, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Pulmonary Embolism

Condition Hierarchy (Ancestors)

Lung DiseasesRespiratory Tract DiseasesEmbolismEmbolism and ThrombosisVascular DiseasesCardiovascular Diseases

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

Locations