- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00127738
Renal Atherosclerotic Revascularization Evaluation: RAVE Study
January 8, 2007 updated by: Sunnybrook Health Sciences Centre
The RAVE study will compare renal revascularization to medical management for people with atherosclerotic renal vascular disease (ARVD) and the indication for revascularization.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Detailed Description
It is uncertain whether patients with renal vascular disease will have renal or mortality benefits from re-establishing renal blood flow with renal revascularization procedures.
Patients will be assessed for the standard nephrology research outcomes of progression to doubling of creatinine, need for dialysis, and death, as well as other cardiovascular outcomes.
The investigators will also establish whether the use of a new inexpensive, simple and available ultrasound test, the renal resistance index (RRI), can identify patients with renal vascular disease who will not benefit from renal revascularization procedures.
Study Type
Interventional
Enrollment
240
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Ontario
-
Toronto, Ontario, Canada, M4N 3M5
- Sunnybrook & Women's College Health Sciences Centre
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
55 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- Systolic blood pressure > 140 mmHg and/or diastolic blood pressure > 90 mmHg despite at least 3 antihypertensive medications
- Systolic blood pressure >140 mmHg and/or diastolic blood pressure > 90 mmHg on two antihypertensives with: a rise in creatinine > 20% after initiation of an angiotensin-converting enzyme inhibitor (ACEi) or angiotensin receptor blocker (ARB); the sudden onset of hypertension occurring after age 55; hypokalemia or the presence of an abdominal bruit; a history of flash pulmonary edema; or any three of: peripheral vascular disease, coronary artery disease, cerebrovascular disease, smoking, hyperlipidemia, diabetes or male gender.
Exclusion Criteria:
- Serum creatinine > 220 umol/L or estimated glomerular filtration rate (GFR) by Cockroft-Gault equation < 20 ml/min
- Patients who are unwilling or unable to give informed consent
- Known contraindication to renal revascularization such as anaphylactic allergy to contrast dye
- An abdominal aortic aneurysm requiring surgery
- A single functioning kidney; a total occlusion of the renal artery or renal artery stenosis due to fibromuscular dysplasia.
- Previous revascularization
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
---|
Death
|
Dialysis
|
Doubling of creatinine
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Investigators
- Principal Investigator: Sheldon Tobe, MD, Sunnybrook & Women's College Health Sciences Centre
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
January 1, 2005
Study Completion
December 1, 2006
Study Registration Dates
First Submitted
August 4, 2005
First Submitted That Met QC Criteria
August 4, 2005
First Posted (Estimate)
August 8, 2005
Study Record Updates
Last Update Posted (Estimate)
January 11, 2007
Last Update Submitted That Met QC Criteria
January 8, 2007
Last Verified
February 1, 2006
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 216-2004
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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