Non-Contrast Magnetic Resonance Angiography Assessment of Patients Referred for Transcatheter Aortic Valve Implantation

December 20, 2016 updated by: Troy LaBounty, University of Michigan

Can Non-Contrast Magnetic Resonance Angiography Accurately Define Arterial Access and Aortic Root Anatomy in Patients Referred for Transcatheter Aortic Valve Implantation?

The overall objective of this proposal is to examine the feasibility and accuracy of non-contrast magnetic resonance angiography (MRA) to comprehensively evaluate individuals referred for transcatheter aortic valve implantation (TAVI).

Study Overview

Status

Terminated

Conditions

Study Type

Observational

Enrollment (Actual)

12

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Michigan
      • Ann Arbor, Michigan, United States, 48109
        • University of Michigan Cardiovascular Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • ADULT
  • OLDER_ADULT
  • CHILD

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Study population will include patients undergoing clinically indicated computed tomography angiography for evaluation for possible transcatheter aortic valve implantation.

Description

Inclusion Criteria:

  • Adults with severe aortic stenosis referred for possible transcatheter aortic valve implantation with clinically indicated computed tomography imaging

Exclusion Criteria:

  • Inability or unwillingness to consent
  • Inability to complete magnetic resonance imaging (MRI) study
  • Contraindication to MRI
  • Participation in another research study
  • Non-diagnostic computed tomography scan

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Minimal luminal size for aorta and ileofemoral arteries
Time Frame: 3 hours
Compare luminal diameter for each segment of the ileofemoral arteries and aorta between MRI and CT
3 hours

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Graded image quality
Time Frame: 3 hours
Compare graded image quality for ileofemoral arteries, aorta, and aortic annulus between MRI and CT
3 hours
Annular size
Time Frame: 3 hours
Compare annular diameter, area, and perimeter between MRI and CT
3 hours

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Michigan

Investigators

  • Principal Investigator: Troy M LaBounty, M.D., University of Michigan

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

December 1, 2013

Primary Completion (ACTUAL)

January 1, 2014

Study Completion (ACTUAL)

January 1, 2014

Study Registration Dates

First Submitted

November 8, 2013

First Submitted That Met QC Criteria

December 6, 2013

First Posted (ESTIMATE)

December 11, 2013

Study Record Updates

Last Update Posted (ESTIMATE)

December 22, 2016

Last Update Submitted That Met QC Criteria

December 20, 2016

Last Verified

December 1, 2016

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • HUM00070087

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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