- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02065648
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.
Sponsor
Collaborators
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
Keywords
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.
Clinical Trials on Vascular Disease
-
Stanford UniversityTerminatedPAD - Peripheral Arterial Disease | PVD- Peripheral Vascular DiseaseUnited States
-
Baylor UniversityNational Institute on Aging (NIA)RecruitingArterial Occlusive Diseases | Peripheral Arterial Disease | Atherosclerosis | Vascular Diseases, PeripheralUnited States
-
C. R. BardCromsourceCompletedVascular Diseases, PeripheralGermany, Poland
-
Horizons International Peripheral GroupAdvanced Catheter Therapies, Inc.CompletedCardiovascular Disease | Peripheral Arterial Disease | Peripheral Vascular DiseaseUnited States
-
Abbott Medical DevicesCompletedCardiovascular Disease | Peripheral Vascular DiseaseUnited States
-
Unity Health TorontoUnknownPeripheral Vascular Disease Patient
-
Stanford UniversityNational Heart, Lung, and Blood Institute (NHLBI)Not yet recruitingPeripheral Vascular Disease | Peripheral Artery DiseaseUnited States
-
C. R. BardCompletedArterial Occlusive Diseases | Peripheral Arterial Disease | Peripheral Vascular DiseasesUnited States
-
University of MichiganTerminatedPeripheral Vascular Disease | Peripheral Artery DiseaseUnited States
-
SensomeRecruitingPeripheral Vascular DiseaseBelgium