- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01576835
Renal Artery Contrast-Free Trial (REACT)
Comparison of Non-contrast Renal Artery Magnetic Resonance Angiography With Contrast-enhanced CT Angiography
Study Overview
Status
Conditions
Detailed Description
REACT is a prospective, minimal-risk, and multi-center international trial. The purpose of the study is to evaluate the safety and efficacy of non-contrast magnetic resonance angiography (MRA) for the diagnosis of renal artery stenosis (RAS).
The current "gold standards" for diagnosing RAS are non-invasive 3D angiography with contrast-enhanced CTA/MRA or invasive X-ray angiography. All of these techniques require the use of an intravenous injection of either iodinated contrast material or gadolinium based agents.
Iodinated contrast agents are contraindicated in patients with renal dysfunction and have increased risk of allergic reaction. Contrast-enhanced magnetic resonance angiography (MRA) with gadolinium has fewer risks associated with it, however, is currently contraindicated in patients with severe renal insufficiency because of concerns about developing a rare but often fatal condition termed nephrogenic systemic fibrosis (NSF).
Non-contrast MRA techniques are felt to provide an avenue for safer, effective vascular imaging in patients both with and without kidney dysfunction. In this trial we propose to validate the contrast-free MRA technique, T-SLIP (time-spatial labeling inversion pulse), for diagnosing RAS. This study will compare T-SLIP to the reference standard of contrast-enhanced CTA and is designed to test its efficacy, reproducibility, reliability, and safety.
Study Type
Enrollment (Actual)
Contacts and Locations
Study Locations
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California
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Salinas, California, United States, 93901
- Central Coast Cardiolgy
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-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Sampling Method
Study Population
Description
Inclusion Criteria:
- The abdominal CTA evaluation form has been completed and confirmed to fit criteria for study enrollment
- The research MRA will be completed within 3 months of abdominal CTA
- Subject signed and dated the informed consent form
- Subject agrees to a "research" abdominal MRA
- Subject is able to follow breathing and scanning instructions
- Subject is at least 18 years of age
Exclusion Criteria:
- Subject has had a significant change in clinical condition between the time of abdominal CTA and abdominal MRA (e.g. worsening renal function, renal vascular intervention)
- Subject has renal stents, or other known material that may affect MR image quality
- Subject has a contraindication to an MRI
- Subject had intravenous gadolinium media within the previous 24 hours
- Subject has a baseline heart rate >90 beats per minute or respiratory rate >25 breaths/minute
Study Plan
How is the study designed?
Design Details
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Accuracy of non-contrast renal MR angiography for assessment of renal artery stenosis (RAS)
Time Frame: up to study closure, estimated 3 months
|
Accuracy of renal T-SLIP for assessing RAS severity in comparison to abdominal CTA.
CTA is being used as the gold standard for comparison
|
up to study closure, estimated 3 months
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Safety assessment of non-contrast renal artery imaging
Time Frame: may be followed on average up to 3 months after closure
|
Safety assessment of T-SLIP will be reported by documenting adverse clinical events (e.g.
patient discomfort during scan)
|
may be followed on average up to 3 months after closure
|
Image quality
Time Frame: up to study closure, estimated 3 months
|
MR angiography image quality will be determined in a blinded fashion by two independent readers.
This will be reported separately.
|
up to study closure, estimated 3 months
|
Collaborators and Investigators
Collaborators
Investigators
- Principal Investigator: Timothy S. Albert, MD, Central Coast Cardiovascular Research
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- REACT2012
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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