NCT04654156

Brief Summary

Pulmonary embolism is a common cardiovascular disease and thoracic CT angiography is currently considered the gold standard for its non-invasive diagnosis. However, the diagnostic performance of CT angiography can be hampered by an insufficient enhancement of pulmonary arteries. Contrast Enhancement Boost (CE Boost) is a post-processing technique using an iodine density map to artificially improve pulmonary artery enhancement. This retrospective study compares standard CT-angiography images with CE Boost images to assess the potential improvement of diagnostic performance for the detection of pulmonary embolism.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
60

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Jan 2019

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

Study Start

First participant enrolled

January 1, 2019

Completed
Same day until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2019

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2019

Completed
1.8 years until next milestone

First Submitted

Initial submission to the registry

October 6, 2020

Completed
2 months until next milestone

First Posted

Study publicly available on registry

December 4, 2020

Completed
Last Updated

December 4, 2020

Status Verified

November 1, 2020

Enrollment Period

Same day

First QC Date

October 6, 2020

Last Update Submit

November 29, 2020

Conditions

Keywords

Pulmonary embolism

Outcome Measures

Primary Outcomes (1)

  • Number of thrombi within each branch of the pulmonary arteries

    The pulmonary arteries were divided into 11 zones according to their anatomical characteristics then each visible thrombus was reported in a Excel table according to the zone where it was located

    Between March and June 2018

Study Arms (2)

Pathological group

Patients with pulmonary embolism on thoracic CT angiography

Diagnostic Test: Contrast Boost post processing technique

Healthy group

Patients without pulmonary embolism on thoracic CT angiography

Diagnostic Test: Contrast Boost post processing technique

Interventions

Contrast Enhancement Boost is a post-processing technique that uses an iodine density map generated by subtracting a pre- and post-contrast CT acquisition to artificially enhance pulmonary artery enhancement.

Healthy groupPathological group

Eligibility Criteria

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

Patient referred in our institution by emergency practitioners who underwent thoracic CT angiography for clinical suspicion of pulmonary embolism between March and June 2018

You may qualify if:

  • Patient who underwent thoracic CT angiography for suspicion of pulmonary embolism in our institution between March and June 2018

You may not qualify if:

  • None

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

CHRU Nancy

Nancy, Meurthe-et-Moselle, 54000, France

Location

MeSH Terms

Conditions

Pulmonary Embolism

Condition Hierarchy (Ancestors)

Lung DiseasesRespiratory Tract DiseasesEmbolismEmbolism and ThrombosisVascular DiseasesCardiovascular Diseases

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

October 6, 2020

First Posted

December 4, 2020

Study Start

January 1, 2019

Primary Completion

January 1, 2019

Study Completion

January 1, 2019

Last Updated

December 4, 2020

Record last verified: 2020-11

Data Sharing

IPD Sharing
Will not share

Locations