Renal Artery Contrast-Free Trial (REACT)

The recruitment status of this study is unknown because the information has not been verified recently.
Verified April 2012 by Central Coast Cardiovascular Research.
Recruitment status was  Recruiting
Sponsor:
Collaborator:
Toshiba America Medical Systems, Inc.
Information provided by (Responsible Party):
Timothy Albert MD, FACC, Central Coast Cardiovascular Research
ClinicalTrials.gov Identifier:
NCT01576835
First received: April 10, 2012
Last updated: April 11, 2012
Last verified: April 2012
  Purpose

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 Phase
Renal Artery Stenosis
Kidney Diseases
Hypertension
Phase 4

Study Type: Observational
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

Resource links provided by NLM:


Further study details as provided by Central Coast Cardiovascular Research:

Primary Outcome Measures:
  • 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


Secondary Outcome Measures:
  • 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.


Estimated Enrollment: 75
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)
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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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.

Criteria

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
  Contacts and Locations
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, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01576835

Contacts
Contact: Timothy S. Albert, MD 831-758-2100 timothy.albert@gmail.com
Contact: Nancy L. Yellin, RN, MSN 831-234-8761 nyellin.research@gmail.com

Locations
United States, California
Central Coast Cardiolgy Recruiting
Salinas, California, United States, 93901
Contact: Timothy S. Albert, MD    831-758-2100    timothy.albert@gmail.com   
Contact: Nancy L. Yellin, RN, MSN    831-234-8761    nyellin.research@gmail.com   
Principal Investigator: Timothy S. Albert, MD         
Sponsors and Collaborators
Central Coast Cardiovascular Research
Toshiba America Medical Systems, Inc.
Investigators
Principal Investigator: Timothy S. Albert, MD Central Coast Cardiovascular Research
  More Information

No publications provided

Responsible Party: Timothy Albert MD, FACC, Secretary, Central Coast Cardiovascular Research
ClinicalTrials.gov Identifier: NCT01576835     History of Changes
Other Study ID Numbers: REACT2012
Study First Received: April 10, 2012
Last Updated: April 11, 2012
Health Authority: United States: Institutional Review Board

Keywords provided by Central Coast Cardiovascular Research:
Non-contrast

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

ClinicalTrials.gov processed this record on August 19, 2014