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Magnetic Resonance Imaging for Evaluating Kidney Function

Primary Purpose

Healthy, Renovascular Hypertension

Status
Completed
Phase
Locations
United States
Study Type
Observational
Intervention
Sponsored by
National Institutes of Health Clinical Center (CC)
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an observational trial for Healthy focused on measuring Atherosclerosis, Hypertension, Magnetic Resonance Angiography

Eligibility Criteria

undefined - undefined (Child, Adult, Older Adult)All SexesAccepts Healthy Volunteers

INCLUSION CRITERIA 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. EXCLUSION CRITERIA 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. Clinically unstable patients and those unable to tolerate a 1-2 hour MR study. Examples of medical conditions that would lead to exclusion include unstable angina, dyspnea at rest, severe pain at rest, or severe back pain. 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.

Sites / Locations

  • Warren G. Magnuson Clinical Center (CC)

Outcomes

Primary Outcome Measures

Secondary Outcome Measures

Full Information

First Posted
August 11, 2000
Last Updated
March 3, 2008
Sponsor
National Institutes of Health Clinical Center (CC)
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1. Study Identification

Unique Protocol Identification Number
NCT00006173
Brief Title
Magnetic Resonance Imaging for Evaluating Kidney Function
Official Title
Assessment of Renal Artery Stenosis and Renovascular Hypertension by Contrast Enhanced Magnetic Resonance Imaging: A Pilot Study
Study Type
Observational

2. Study Status

Record Verification Date
January 2004
Overall Recruitment Status
Completed
Study Start Date
August 2000 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
January 2004 (undefined)

3. Sponsor/Collaborators

Name of the Sponsor
National Institutes of Health Clinical Center (CC)

4. Oversight

5. Study Description

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.
Detailed Description
Renovascular hypertension (RVH) is a potentially curable disease affecting 0.5-5% 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 diagnosis and pathophysiologic understanding of RVH.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Healthy, Renovascular Hypertension
Keywords
Atherosclerosis, Hypertension, Magnetic Resonance Angiography

7. Study Design

Enrollment
40 (false)

10. Eligibility

Sex
All
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
INCLUSION CRITERIA 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. EXCLUSION CRITERIA 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. Clinically unstable patients and those unable to tolerate a 1-2 hour MR study. Examples of medical conditions that would lead to exclusion include unstable angina, dyspnea at rest, severe pain at rest, or severe back pain. 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.
Facility Information:
Facility Name
Warren G. Magnuson Clinical Center (CC)
City
Bethesda
State/Province
Maryland
ZIP/Postal Code
20892
Country
United States

12. IPD Sharing Statement

Citations:
PubMed Identifier
9894438
Citation
Kulkarni S, O'Farrell I, Erasi M, Kochar MS. Stress and hypertension. WMJ. 1998 Dec;97(11):34-8.
Results Reference
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PubMed Identifier
10726080
Citation
Bouyounes BT, Libertino JA. Renovascular hypertension. Curr Opin Urol. 1999 Mar;9(2):111-4. doi: 10.1097/00042307-199903000-00004.
Results Reference
background
PubMed Identifier
10321824
Citation
Taylor A. Radionuclide renography: a personal approach. Semin Nucl Med. 1999 Apr;29(2):102-27. doi: 10.1016/s0001-2998(99)80003-8.
Results Reference
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Magnetic Resonance Imaging for Evaluating Kidney Function

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