Renal Artery StenosisREACTNCT01576835
Renal Artery Contrast-Free Trial
An observational study of Renal Artery Stenosis and Kidney Diseases, run by Central Coast Cardiovascular Research at 1 site in United States.
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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Renal Artery Stenosis, Kidney Diseases, Hypertension
- How many people
- 75 participants
- Where
- 1 siteUnited States
- Study dates
- Feb 2012to Dec 2012
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
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.
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Comparison of Non-contrast Renal Artery Magnetic Resonance Angiography With Contrast-enhanced CT Angiography
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.
Read the 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.
- Conditions
- Renal Artery Stenosis, Kidney Diseases, Hypertension
- Keywords
- Non-contrast
- Medical subject headings
- Renal Artery Obstruction, Kidney Diseases, Hypertension
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: up to study closure, estimated 3 months
Secondary outcomes (2)
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)
Measured: may be followed on average up to 3 months after closure
Image quality
MR angiography image quality will be determined in a blinded fashion by two independent readers. This will be reported separately.
Measured: up to study closure, estimated 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Apr 2012 (estimated)
- Study startFeb 2012
- Primary completionNov 2012
- Study completionDec 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Renal Artery StenosisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 75 participants (actual)
Sponsor and investigators
- Lead sponsor
- Central Coast Cardiovascular Research
- Sponsor type
- University, hospital or other
- Collaborators
- Toshiba America Medical Systems, Inc.
- Responsible party
- Principal investigator, Timothy Albert MD, FACC, Central Coast Cardiovascular Research
- Investigators
- Timothy S. Albert, MD, Principal investigator, Central Coast Cardiovascular Research
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01576835
- Sponsor's protocol ID
- REACT2012
- Acronym
- REACT
- Status last verified
- Aug 2015
- First submitted
- 10 Apr 2012
- Last updated
- 26 Aug 2015
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 26 Aug 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of Non-contrast Renal Artery Magnetic Resonance Angiography With Contrast-enhanced CT Angiography
- ClinicalTrials.gov ID
- NCT01576835
- Acronym / sponsor ID
- REACT / REACT2012
- Conditions
- Renal Artery Stenosis, Kidney Diseases, Hypertension
- Keywords
- Non-contrast
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 75 participants (actual)
- Lead sponsor
- Central Coast Cardiovascular ResearchUniversity, hospital or other
- Collaborators
- Toshiba America Medical Systems, Inc.
- Study start
- Feb 2012
- Primary completion
- Nov 2012 (actual)
- Study completion
- Dec 2012 (actual)
- First posted
- 13 Apr 2012 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Observational model
- Case only
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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
2 secondary outcomes
Safety assessment of non-contrast renal artery imaging
Time frame: may be followed on average up to 3 months after closure
Image quality
Time frame: up to study closure, estimated 3 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Aug 2015.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Timothy S. Albert, MD principal investigator
Central Coast Cardiovascular Research
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Renal Artery Stenosis and Kidney Diseases, run by Central Coast Cardiovascular Research at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 26 Aug 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Accuracy of non-contrast renal MR angiography for assessment of renal artery stenosis (RAS) (time frame: up to study closure, estimated 3 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Aug 2015.