NCT03754673

Brief Summary

The aim of this work is to emphasize the role of non-contrast MR imaging in diagnosis of acute pulmonary embolism in comparison to CTA and contrast enhanced MRA as gold standard techniques.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
50

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Dec 2018

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

November 23, 2018

Completed
4 days until next milestone

First Posted

Study publicly available on registry

November 27, 2018

Completed
4 days until next milestone

Study Start

First participant enrolled

December 1, 2018

Completed
1.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2020

Completed
4 months until next milestone

Study Completion

Last participant's last visit for all outcomes

April 30, 2020

Completed
Last Updated

May 27, 2020

Status Verified

May 1, 2020

Enrollment Period

1.1 years

First QC Date

November 23, 2018

Last Update Submit

May 24, 2020

Conditions

Pulmonary Embolism

Outcome Measures

Primary Outcomes (1)

  • detection of pulmonary embolism by MRI without contrast administration

    diagnosis and detection of pulmonary embolism by MRI in comparison with MSCT pulmonary angiography

    baseline

Interventions

MRIDEVICE

MRI pulmonary with no contrast administration

Eligibility Criteria

Age18 Years - 75 Years
Sexall
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

1. Full history taking and clinical examination. 2. CT PA or contrast enhanced MR PA.

You may qualify if:

  • High clinical probability of PE assessed by the revised Geneva score and / or had a D- dimer level \> 500 µg L1 on an ELISA-based test
  • Patients with clinically evident and confirmed by CT PA or contrast enhanced MR-PA to have PE .
  • Both sexes will be included in addition to pregnant women.
  • No age predilection but children Less than 18 years old will not be included

You may not qualify if:

  • Patients known to have contraindication for MRI, e.g. an implanted magnetizable device, metallic ocular implant, pacemakers, or claustrophobia.
  • Patients with bad general condition with signs of a severe PE such as unstable haemodynamic.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Hossam Mohammed Mostafa

Asyut, 020, Egypt

Location

Related Publications (1)

  • Nyren S, Nordgren Rogberg A, Vargas Paris R, Bengtsson B, Westerlund E, Lindholm P. Detection of pulmonary embolism using repeated MRI acquisitions without respiratory gating: a preliminary study. Acta Radiol. 2017 Mar;58(3):272-278. doi: 10.1177/0284185116651003. Epub 2016 Jul 19.

    PMID: 27273375BACKGROUND

MeSH Terms

Conditions

Pulmonary Embolism

Condition Hierarchy (Ancestors)

Lung DiseasesRespiratory Tract DiseasesEmbolismEmbolism and ThrombosisVascular DiseasesCardiovascular Diseases

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
CROSS SECTIONAL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant Lecturer

Study Record Dates

First Submitted

November 23, 2018

First Posted

November 27, 2018

Study Start

December 1, 2018

Primary Completion

January 1, 2020

Study Completion

April 30, 2020

Last Updated

May 27, 2020

Record last verified: 2020-05

Locations

EG(1)