Renal Artery Contrast-Free Trial
| Status: | Completed |
|---|---|
| Conditions: | High Blood Pressure (Hypertension), Renal Impairment / Chronic Kidney Disease, Nephrology |
| Therapuetic Areas: | Cardiology / Vascular Diseases, Nephrology / Urology |
| Healthy: | No |
| Age Range: | 18 - Any |
| Updated: | 4/21/2016 |
| Start Date: | February 2012 |
| End Date: | December 2012 |
Comparison of Non-contrast Renal Artery Magnetic Resonance Angiography With Contrast-enhanced CT Angiography
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.
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.
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.
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.
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
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