Renal Artery Contrast-Free Trial (REACT)
This study will compare the results of a clinically ordered abdominal CT angiography to a research non-contrast MR angiogram (MRA). CTA is a "gold-standard" for identifying blockages in the kidney arteries or other blood vessel problems. CTA requires radiation and contrast to obtain useful images. Conversely, the MR abdomen technique being used for the study uses no radiation or contrast and is felt to be a safer option for individuals who have kidney problems. there is benefit to establishing non-contrast MRA as a clinically accurate test.
|Study Design:||Observational Model: Case-Only
Time Perspective: Prospective
|Official Title:||Comparison of Non-contrast Renal Artery Magnetic Resonance Angiography With Contrast-enhanced CT Angiography|
- Accuracy of non-contrast renal MR angiography for assessment of renal artery stenosis (RAS) [ Time Frame: up to study closure, estimated 3 months ] [ Designated as safety issue: No ]Accuracy of renal T-SLIP for assessing RAS severity in comparison to abdominal CTA. CTA is being used as the gold standard for comparison
- Safety assessment of non-contrast renal artery imaging [ Time Frame: may be followed on average up to 3 months after closure ] [ Designated as safety issue: Yes ]Safety assessment of T-SLIP will be reported by documenting adverse clinical events (e.g. patient discomfort during scan)
- Image quality [ Time Frame: up to study closure, estimated 3 months ] [ Designated as safety issue: No ]MR angiography image quality will be determined in a blinded fashion by two independent readers. This will be reported separately.
|Study Start Date:||February 2012|
|Estimated Study Completion Date:||July 2012|
|Estimated Primary Completion Date:||June 2012 (Final data collection date for primary outcome measure)|
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.
|Contact: Timothy S. Albert, MDfirstname.lastname@example.org|
|Contact: Nancy L. Yellin, RN, MSNemail@example.com|
|United States, California|
|Central Coast Cardiolgy||Recruiting|
|Salinas, California, United States, 93901|
|Contact: Timothy S. Albert, MD 831-758-2100 firstname.lastname@example.org|
|Contact: Nancy L. Yellin, RN, MSN 831-234-8761 email@example.com|
|Principal Investigator: Timothy S. Albert, MD|
|Principal Investigator:||Timothy S. Albert, MD||Central Coast Cardiovascular Research|