Renal Artery Contrast-Free Trial (REACT)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01576835
Recruitment Status : Completed
First Posted : April 13, 2012
Last Update Posted : August 26, 2015
Toshiba America Medical Systems, Inc.
Information provided by (Responsible Party):
Timothy Albert MD, FACC, Central Coast Cardiovascular Research

Brief Summary:
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.

Condition or disease
Renal Artery Stenosis Kidney Diseases Hypertension

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 : Observational
Actual Enrollment : 75 participants
Observational Model: Case-Only
Time Perspective: Prospective
Official Title: Comparison of Non-contrast Renal Artery Magnetic Resonance Angiography With Contrast-enhanced CT Angiography
Study Start Date : February 2012
Actual Primary Completion Date : November 2012
Actual Study Completion Date : December 2012

Primary Outcome Measures :
  1. 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

Secondary Outcome Measures :
  1. 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)

  2. 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.

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population
Patients who have had an abdominal CT for any reason will be considered for the REACT study. They may be referred from private practice or imaging center.

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01576835

United States, California
Central Coast Cardiolgy
Salinas, California, United States, 93901
Sponsors and Collaborators
Central Coast Cardiovascular Research
Toshiba America Medical Systems, Inc.
Principal Investigator: Timothy S. Albert, MD Central Coast Cardiovascular Research

Responsible Party: Timothy Albert MD, FACC, Secretary, Central Coast Cardiovascular Research Identifier: NCT01576835     History of Changes
Other Study ID Numbers: REACT2012
First Posted: April 13, 2012    Key Record Dates
Last Update Posted: August 26, 2015
Last Verified: August 2015

Keywords provided by Timothy Albert MD, FACC, Central Coast Cardiovascular Research:

Additional relevant MeSH terms:
Kidney Diseases
Renal Artery Obstruction
Urologic Diseases
Arterial Occlusive Diseases
Vascular Diseases
Cardiovascular Diseases