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NCT02793570 Clinical Trial

Non-contrast 3D MR Angiography for Assessment of the Thoracic Aorta in Pregnancy

Pregnancy Clinical Trial

Official title:
Native High-resolution 3D SSFP MR Angiography for Assessment of the Thoracic Aorta in Pregnant Subjects With Familial Aortopathies

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT02793570
Other study ID # RRK
Secondary ID
Status Completed
Phase N/A
First received June 3, 2016
Last updated November 8, 2016
Start date January 2015
Est. completion date October 2016

Study information
Verified date November 2016
Source University Hospital Birmingham NHS Foundation Trust
Contact n/a
Is FDA regulated No
Health authority United Kingdom: National Health Service
Study type Observational

Clinical Trial Summary

Introduction: Native magnetic resonance angiography (MRA) is recommended to assess the thoracic aorta during pregnancy, avoiding the risks of ionising radiation and contrast agent administration. This guidance is however, based only on consensus opinion supported by limited case reports (level of evidence C).

Aim: To evaluate the feasibility of performing native 3D steady-state free-precession (SSFP) MRA in pregnant subjects with inherited aortopathy to guide timing and mode of delivery.

Recruitment information / eligibility
Status Completed
Enrollment 15
Est. completion date October 2016
Est. primary completion date October 2016
Accepts healthy volunteers No
Gender Female
Age group N/A and older
Eligibility Inclusion Criteria:

- Any pregnant subject with a history of familial aortopathy

Exclusion Criteria:

Study Design

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

Intervention

Other:
• observational

Locations
Country Name City State
United Kingdom QEHB Birmingham

Sponsors (1)
Lead Sponsor Collaborator
University Hospital Birmingham NHS Foundation Trust

Country where clinical trial is conducted

United Kingdom, 

Outcome
Type Measure Description Time frame Safety issue
Primary Gestation at delivery 40 weeks Yes
Primary Completion of non-contrast 3D MRA aorta 40 weeks Yes
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