Renal Artery Contrast-Free Trial

Hypertension Clinical Trial

— REACT  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01576835
• Other study ID #: REACT2012
• Status: Completed
• Phase: Phase 4
• First received: April 10, 2012
• Last updated: August 24, 2015
• Start date: February 2012
• Est. completion date: December 2012

Study information

• Verified date: August 2015
• Source: Central Coast Cardiovascular Research
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 75
• Est. completion date: December 2012
• Est. primary completion date: November 2012
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Study Design

Observational Model: Case-Only, Time Perspective: Prospective

Related Conditions & MeSH terms

• Hypertension
• Kidney Diseases
• Renal Artery Obstruction
• Renal Artery Stenosis

Locations

Country	Name	City	State
United States	Central Coast Cardiolgy	Salinas	California

Sponsors (2)

Lead Sponsor	Collaborator
Central Coast Cardiovascular Research	Toshiba America Medical Systems, Inc.

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Accuracy of non-contrast renal MR angiography for assessment of renal artery stenosis (RAS)	Accuracy of renal T-SLIP for assessing RAS severity in comparison to abdominal CTA. CTA is being used as the gold standard for comparison	up to study closure, estimated 3 months	No
Secondary	Safety assessment of non-contrast renal artery imaging	Safety assessment of T-SLIP will be reported by documenting adverse clinical events (e.g. patient discomfort during scan)	may be followed on average up to 3 months after closure	Yes
Secondary	Image quality	MR angiography image quality will be determined in a blinded fashion by two independent readers. This will be reported separately.	up to study closure, estimated 3 months	No