Syngo NATIVE Contrast Enhanced 3D MRA on 3T Verio Magnet

January 31, 2017 updated by: Rola Saouaf, MD, Cedars-Sinai Medical Center

NATIVE Sequence for Non-Contrast MR Angiogram Compared With Conventional Contrast Enhanced 3D MRA on 3T Verio Magnet

The purpose of the study is to compare non-contrast abdominal MR Angiogram (MRA) syngo NATIVE sequence performed on a 3T Verio Siemens magnet to a standard contrast-enhanced MRA performed as part of routine clinical care in patients with normal renal function to determine if the non-contrast NATIVE sequence is a viable alternative to contrast enhanced MRA in patients with renal insufficiency. There are no interventions--this is an observational study.

Study Overview

Status

Completed

Conditions

Detailed Description

If the NATIVE sequence proves to be a viable alternative to contrast enhanced MRA it will provide imaging physicians with the diagnostic tool to assess vascular disease in patients with renal insufficiency without placing them at risk for additional co-morbidities.

Study Type

Observational

Enrollment (Actual)

20

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

    • California
      • Los Angeles, California, United States, 90048
        • Cedars-Sinai Medical 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

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Consenting patients referred for standard of care contrast-enhanced abdominal MR Angiography

Description

Inclusion Criteria:

Over age 18 Signed informed consent Referred for standard of care MRA

Exclusion Criteria:

No contra-indications for MRI/MRA ie implants which could interfere with magnets Renal insufficiency which would preclude use of contrast-enhanced contrast for a standard of care MRA

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

  • Observational Models: Case-Only
  • Time Perspectives: Prospective

Cohorts and Interventions

Group / Cohort
Syngo NATIVE MRA
All consenting participants will receive an additional non-contrast Syngo NATIVE MRA sequence prior to contrast injection their standard of care MRA.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Effectiveness of non-contrast enhanced MRA sequence
Time Frame: 36 months
Compare non-contrast enhanced MRA images with contrast-enhanced MRA images.
36 months

Collaborators and Investigators

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

Investigators

  • Principal Investigator: Rola Saouaf, MD, Cedars-Sinai Medical Center
  • Study Director: Franklin G. Moser, MD, Cedars-Sinai Medical Center

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

May 1, 2012

Primary Completion (Actual)

March 1, 2015

Study Completion (Actual)

March 1, 2015

Study Registration Dates

First Submitted

January 17, 2014

First Submitted That Met QC Criteria

February 14, 2014

First Posted (Estimate)

February 19, 2014

Study Record Updates

Last Update Posted (Estimate)

February 2, 2017

Last Update Submitted That Met QC Criteria

January 31, 2017

Last Verified

January 1, 2017

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CSMC-2011-MR-02-01-NATIVE-Mos

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

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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