NCT02065648

Brief Summary

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.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
20

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started May 2012

Typical duration for all trials

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

Study Start

First participant enrolled

May 1, 2012

Completed
1.7 years until next milestone

First Submitted

Initial submission to the registry

January 17, 2014

Completed
1 month until next milestone

First Posted

Study publicly available on registry

February 19, 2014

Completed
1 year until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2015

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2015

Completed
Last Updated

February 12, 2025

Status Verified

February 1, 2025

Enrollment Period

2.8 years

First QC Date

January 17, 2014

Last Update Submit

February 10, 2025

Conditions

Vascular Disease

Keywords

MRASyngo NativeGadoliniumNon contrast

Outcome Measures

Primary Outcomes (1)

  • Effectiveness of non-contrast enhanced MRA sequence

    Compare non-contrast enhanced MRA images with contrast-enhanced MRA images.

    36 months

Study Arms (1)

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.

Eligibility Criteria

Age18 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

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

You may qualify if:

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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Cedars-Sinai Medical Center

Los Angeles, California, 90048, United States

Location

MeSH Terms

Conditions

Vascular Diseases

Condition Hierarchy (Ancestors)

Cardiovascular Diseases

Study Officials

  • Rola Saouaf, MD

    Cedars-Sinai Medical Center

    PRINCIPAL INVESTIGATOR

  • Franklin G. Moser, MD

    Cedars-Sinai Medical Center

    STUDY DIRECTOR

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Director, Body and Cardiac MRI

Study Record Dates

First Submitted

January 17, 2014

First Posted

February 19, 2014

Study Start

May 1, 2012

Primary Completion

March 1, 2015

Study Completion

March 1, 2015

Last Updated

February 12, 2025

Record last verified: 2025-02

Data Sharing

IPD Sharing
Will not share

Locations

US(1)