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

Vascular Disease Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02065648
• Other study ID #: CSMC-2011-MR-02-01-NATIVE-Mos
• Status: Completed
• Phase: N/A
• First received: January 17, 2014
• Last updated: January 31, 2017
• Start date: May 2012
• Est. completion date: March 2015

Study information

• Verified date: January 2017
• Source: Cedars-Sinai Medical Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 20
• Est. completion date: March 2015
• Est. primary completion date: March 2015
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Vascular Disease
• Vascular Diseases

Locations

Country	Name	City	State
United States	Cedars-Sinai Medical Center	Los Angeles	California

Sponsors (2)

Lead Sponsor	Collaborator
Cedars-Sinai Medical Center	Siemens Corporation, Corporate Technology

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Effectiveness of non-contrast enhanced MRA sequence	Compare non-contrast enhanced MRA images with contrast-enhanced MRA images.	36 months