NCT01558206

Brief Summary

In this study the investigators compare the diagnostic validity of Bedside Ultrasonography of chest and Pulmonary artery CT Angiography in the patients who came to Emergency Department of Alzahra General Hospital from 1 may 2012 to 1 October 2012 with respiratory symptoms and signs in favor of Pulmonary Thromboemboli (PTE).

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
76

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Mar 2012

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
unknown

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

Study Start

First participant enrolled

March 1, 2012

Completed
7 days until next milestone

First Submitted

Initial submission to the registry

March 8, 2012

Completed
12 days until next milestone

First Posted

Study publicly available on registry

March 20, 2012

Completed
8 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2012

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2012

Completed
Last Updated

March 20, 2012

Status Verified

March 1, 2012

Enrollment Period

8 months

First QC Date

March 8, 2012

Last Update Submit

March 16, 2012

Conditions

Keywords

PTEEmergency bedside ultrasonographypulmonary CT AngiographyPulmonary Wedge infarctionPulmonary Thromboembolism

Outcome Measures

Primary Outcomes (1)

  • Emergency Ultrasonography findings in patients with signs and symptoms in favor of PTE.

    Comparing the Emergency Bedside Ultrasonography findings in PTE with pulmonary CT Angiography findings.

    Within 1 hour of admission

Secondary Outcomes (1)

  • Pulmonary CT Angiography findings in patients with signs and symptoms in favor of PTE.

    Within 24 hours of admission

Study Arms (1)

Patients with impression of PTE

Those with signs and symptoms in favor of pulmonary thromboembolism.

Other: Pulmonary artery CT AngiographyOther: Emergency Bedside Ultrasonography of chest

Interventions

Performing Pulmonary artery CT Angiography for patients with signs and symptoms in favor of PTE.

Patients with impression of PTE

Performing Emergency Bedside Ultrasonography of chest at the time of presentation for patients with signs and symptoms in favor of PTE.

Patients with impression of PTE

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Patients who come to the Emergency Department of Alzahra General Hospital with signs and symptoms in favor of PTE.

You may qualify if:

  • Patients with signs or symptoms in favor of PTE who come to Emergency department of Alzahra General Hospital.

You may not qualify if:

  • previous history of Allergy to IV contrast
  • Serum creatinin more than 1.8
  • patients that will not agree to participate in the study.
  • pregnancy
  • Body weight more than 120 kg

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Emergency Department of alzahra General Hospital, Isfahan University of Medical Sciences

Isfahan, Isfahan, Iran

Location

MeSH Terms

Conditions

Pulmonary Embolism

Condition Hierarchy (Ancestors)

Lung DiseasesRespiratory Tract DiseasesEmbolismEmbolism and ThrombosisVascular DiseasesCardiovascular Diseases

Study Officials

  • Keihan Golshani, M.D.

    Isfahan University of Medical Sciences

    STUDY CHAIR

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant Professor of Emergency Medicine, Director of Emergency Medicine Residency Program

Study Record Dates

First Submitted

March 8, 2012

First Posted

March 20, 2012

Study Start

March 1, 2012

Primary Completion

November 1, 2012

Study Completion

December 1, 2012

Last Updated

March 20, 2012

Record last verified: 2012-03

Locations