Renal Artery Contrast-Free Trial

NCT01576835 | Completed DMC

• 1 other identifier: REACT2012
• Study Type: observational
• Target: 75
• Locations: 1 country
• Sites: 1

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.

Conditions

Renal Artery Stenosis; Kidney Diseases; Hypertension

Keywords

Non-contrast

Outcome Measures

Primary Outcomes (1)

• 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

Secondary Outcomes (2)

• Safety assessment of non-contrast renal artery imaging

  may be followed on average up to 3 months after closure

• Image quality

  up to study closure, estimated 3 months

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Central Coast Cardiovascular Research: lead
• Toshiba America Medical Systems, Inc.: collaborator

Study Sites (1)

Central Coast Cardiolgy

Salinas, California, 93901, United States

Location

MeSH Terms

Conditions

Renal Artery Obstruction; Kidney Diseases; Hypertension

Condition Hierarchy (Ancestors)

Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Arterial Occlusive Diseases; Vascular Diseases; Cardiovascular Diseases

Study Officials

• Timothy S. Albert, MD

  Central Coast Cardiovascular Research

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Secretary

Study Record Dates

• First Submitted: April 10, 2012
• First Posted: April 13, 2012
• Study Start: February 1, 2012
• Primary Completion: November 1, 2012
• Study Completion: December 1, 2012
• Last Updated: August 26, 2015

Record last verified: 2015-08

Locations

US (1)