Skip to main content
OpenTrials
Completed

NCT Number: NCT01576835

Renal Artery Contrast-Free Trial

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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Renal Artery Stenosis Arterial Occlusive Diseases Cardiovascular Diseases Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Hypertension Kidney Diseases Male Urogenital Diseases Renal Artery Obstruction Urogenital Diseases Urologic Diseases Vascular Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Central Coast Cardiolgy

Salinas, California, 93901, United States

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

  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 outcomes

  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.

Sponsors and collaborators

Lead sponsor

Central Coast Cardiovascular Research

Other

Collaborators

  • Toshiba America Medical Systems, Inc.

Registry information

Official study title

Comparison of Non-contrast Renal Artery Magnetic Resonance Angiography With Contrast-enhanced CT Angiography

Acronym: REACT

Important dates

Study start
2012
Primary completion
2012
Study completion
2012
First posted
Apr 13, 2012
Registry last updated
Aug 26, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.