CI

At a glance

ClinicalIndex Comparison Record
Phase 1Completed
Drug / intervention
MRIprocedure
Likely dose
Not stated in record
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Search/NCT00027469
NCT00027469Phase 1Completed

Evidence of Procedural Embolism Complicating Renal Artery Stenting

National Heart, Lung, and Blood Institute (NHLBI)·interventional·Posted Dec 7, 2001·Updated Mar 4, 2008

In Brief

A Phase 1 clinical trial evaluating MRI for Renal Artery Obstruction and Kidney Disease. Completed, across 1 site.

Detailed Summary

This study will use magnetic resonance imaging (MRI) to picture the kidney and renal arteries (arteries that supply blood to the kidney) in patients scheduled for kidney artery angiogram and angioplasty/stenting procedures. An angiogram is a way of taking pictures of arteries that shows areas of narrowing caused by atherosclerosis-a buildup of plaque on the vessel wall. Angioplasty/stent is a treatment procedure in which a balloon-tipped catheter is inserted in the artery and advanced to the area of blockage to open the vessel, increasing blood flow to the kidney. A permanent metal tube (stent) may or may not be put in place to maintain the opening. During either of these invasive procedures, small pieces of plaque can break off and travel in the blood to lodge elsewhere in the body. This is called embolization. Lodged in the kidney, the embolus can impair kidney function. Currently, these emboli cannot be detected. A new way of visualizing the kidneys that allows detection of emboli may reveal whether material has moved to the kidneys and predict if there will be any kidney damage. Patients 21 years of age and older with suspected kidney artery disease scheduled for invasive angiographic evaluation in NIH protocol 95-H-0047 may be eligible for this study. Participants will be assigned to one of two study groups, based on the angiogram findings and the decision to have the angioplasty/stent procedure. Participants in both groups will have baseline MRI scans up to 2 weeks before the invasive procedure (angiogram with or without angioplasty/stent) and again within a day after the procedure. Patients who undergo angioplasty/stent will have another MRI study within about a month following the procedure. MRI uses a magnetic field and radio waves to produce images of body tissues. The patient lies on a table that slides into a large hollow tube (the scanner). During part of the scan, a material called gadolinium contrast may be injected into a vein. This substance brightens the images to better show the kidneys, their blood vessels and blood flow. The procedure lasts from about 1 to 2 hours. During the MRI, the heart is monitored with an electrocardiogram (EKG) and breathing is monitored with a flexible belt. Blood pressure is measured intermittently. The patient can communicate with a staff member at all times. Blood samples will be drawn from an arm vein at the initial clinic visit, within a day after the procedure and about 1 week after the procedure. For patients who had the angioplasty/stent procedure, a third blood sample will be taken within another 6 six weeks. The blood samples will be used to check for changes in kidney function.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesUnited States
Collaborators--

Timeline

Phase 1CompletedFinished
20022003200420052006200720082009201020112012201320142015201620172018201920202021202220232024202520262027
First PostedDec 7, 2001
Enrollment StartDec 1, 2001
Study CompletionDec 1, 2005
TodayJul 2, 2026
Posted 24.6 years ago

Interventions

MRIprocedure