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

NCT ID: NCT02065648

Last Updated: 2025-02-12

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

20 participants

Study Classification

OBSERVATIONAL

Study Start Date

2012-05-31

Study Completion Date

2015-03-31

Brief Summary

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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.

Detailed Description

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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.

Conditions

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Vascular Disease

Study Design

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Observational Model Type

CASE_ONLY

Study Time Perspective

PROSPECTIVE

Study Groups

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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.

No interventions assigned to this group

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Siemens Corporation, Corporate Technology

INDUSTRY

Sponsor Role collaborator

Cedars-Sinai Medical Center

OTHER

Sponsor Role lead

Responsible Party

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Rola Saouaf, MD

Director, Body and Cardiac MRI

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Rola Saouaf, MD

Role: PRINCIPAL_INVESTIGATOR

Cedars-Sinai Medical Center

Franklin G. Moser, MD

Role: STUDY_DIRECTOR

Cedars-Sinai Medical Center

Locations

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Cedars-Sinai Medical Center

Los Angeles, California, United States

Site Status

Countries

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United States

Other Identifiers

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CSMC-2011-MR-02-01-NATIVE-Mos

Identifier Type: -

Identifier Source: org_study_id

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