Magnetic Resonance Imaging for Evaluating Kidney Function
Assessment of Renal Artery Stenosis and Renovascular Hypertension by Contrast Enhanced Magnetic Resonance Imaging: A Pilot Study
2 other identifiers
observational
40
1 country
1
Brief Summary
Renovascular hypertension (RVH) is a potentially curable disease affecting 0.5-5 percent of patients with hypertension. The current diagnostic work-up of RVH involves a complex algorithm which includes doppler ultrasound, captopril renography and conventional angiography. Because of the expense, risk and inconvenience of this workup, patients may not be correctly diagnosed. Advances in MR technology present the opportunity to develop a single comprehensive test. This would combine an MR angiogram that provides anatomic information about the renal arteries, and an MR renogram that provides information about the functional impact of a stenosis as a cause of hypertension. Our main purpose is to test MR renography with and without an oral angiotensin converting enzyme inhibitor (ACEI) combined with MR angiography against the reference standard of captopril radionuclide renography. Secondary goals of this study are to test whether hypoxia within ischemic kidneys affected by RVH is detectable by T2 weighted (Blood oxygen level dependent or BOLD) MRI. This is considered of value since such a test of oxygenation would further shorten and simplify the diagnostic MR test. Information gained from this study could lead to important changes in the diagnostic and pathophysiologic understanding of RVH.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for all trials
Started Aug 2000
Typical duration for all trials
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
August 1, 2000
CompletedFirst Submitted
Initial submission to the registry
August 11, 2000
CompletedFirst Posted
Study publicly available on registry
August 14, 2000
CompletedStudy Completion
Last participant's last visit for all outcomes
January 1, 2004
CompletedMarch 4, 2008
January 1, 2004
August 11, 2000
March 3, 2008
Conditions
Keywords
Eligibility Criteria
You may qualify if:
- Healthy volunteers or patients with significant clinical suspicion of renovascular hypertension.
- Subjects able to understand the informed consent for this study.
- Subjects must be able to hold their breath for 20 second intervals.
- Patients must be clinically stable and be judged by their physician able to tolerate the MR study of 1.5-2 hour duration.
You may not qualify if:
- Any contraindication for MR study including: pacemaker or other implanted electronic device; cochlear implants; metal in the eye; embedded shrapnel fragments; cerebral aneurysm clips; or medical infusion pumps.
- Allergy to gadolinium, iodinated contrast media, ACEIs, or sulphur-containing medication.
- Patients have a hematocrit at or below 30. Severe anemia may predispose to hypotension after captopril.
- Patients with hyperkalemia (plasma potassium: above 5.0 mmol/L), because of the risk of arrhythmia.
- Pregnancy.
- Nursing mothers.
- Subjects who are claustrophobic and are unable to tolerate MR imaging.
- Patients with a serum creatinine concentration above 4mg/dl.
- Bilateral renal stents.
- Healthy subjects must not have an abnormality detected on dipstick urinalysis, or a systolic BP above 140 mmHg or a diastolic BP above 90 mmHg on screening examination or an abnormal BUN or creatinine level in the blood.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Warren G. Magnuson Clinical Center (CC)
Bethesda, Maryland, 20892, United States
Related Publications (3)
Kulkarni S, O'Farrell I, Erasi M, Kochar MS. Stress and hypertension. WMJ. 1998 Dec;97(11):34-8.
PMID: 9894438BACKGROUNDBouyounes BT, Libertino JA. Renovascular hypertension. Curr Opin Urol. 1999 Mar;9(2):111-4. doi: 10.1097/00042307-199903000-00004.
PMID: 10726080BACKGROUNDTaylor A. Radionuclide renography: a personal approach. Semin Nucl Med. 1999 Apr;29(2):102-27. doi: 10.1016/s0001-2998(99)80003-8.
PMID: 10321824BACKGROUND
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Design
- Study Type
- observational
- Sponsor Type
- NIH
Study Record Dates
First Submitted
August 11, 2000
First Posted
August 14, 2000
Study Start
August 1, 2000
Study Completion
January 1, 2004
Last Updated
March 4, 2008
Record last verified: 2004-01