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NCT00459446 · ClinicalTrials.gov registry record · Phase 1

Imaging of Totally Blocked Arteries

A Phase 1 study, sponsored by National Heart, Lung, and Blood Institute (NHLBI).

Completed
Registry status
Phase 1
Development phase
20
Enrollment target

NCT00459446 is a Phase 1 study that has completed, run by National Heart, Lung, and Blood Institute (NHLBI). The registered enrollment target is 20 participants.

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The verdict

NCT00459446, a Phase 1 study, has completed, sponsored by National Heart, Lung, and Blood Institute (NHLBI).

COMPLETED
Registry status
Phase 1
Development phase
20 participants
Enrollment target

Study Summary

This study will test how well a new contrast agent (dye) used in magnetic resonance imaging (MRI) can help visualize totally blocked arteries that normally supply blood to the neck, arms or legs. Currently used agents work well in visualizing normal or partly blocked arteries (arteries that have some blood flowing through them), but only poorly in totally blocked arteries. This study will see if a contrast agent called gadofosveset can better brighten images of completely blocked arteries. Gadofosveset is approved in Europe for use in MRI scans, but is still considered experimental in the United States. People 18 years of age or older with known or suspected total blockage of an artery to the neck, arm or leg may be eligible for this study. Participants undergo MRI scanning with gadofosveset contrast dye. MRI uses a magnetic field and radio waves to produce images of body tissues and organs. For this procedure, the subject lies on a table that can slide in and out of the tubular scanner, wearing earplugs to muffle loud noises that occur during the scanning process. The procedure lasts about 1.5 to 2 hours, during which the subject may be asked to hold his or her breath several times for as long as 5 to 20 seconds. During the procedure, gadofosveset is injected and several kinds of MRI pictures are taken to understand better how the new agent works. Subjects may be asked to undergo a second scan using conventional MRI contrast dye

Interventions

  • DRUG MS-325 Injection (Gadofosveset Trisodium)

Trial Details

FieldValue
Enrollment Target 20 participants
Start Date 2007-04-05
Phase Phase 1

What the Registry Record Tells You About NCT00459446

The ClinicalTrials.gov registry entry for NCT00459446 describes a study currently listed as completed, categorized as Phase 1. The registered enrollment target is 20 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is National Heart, Lung, and Blood Institute (NHLBI), which has 501 total studies on file at ClinicalTrials.gov.

The record links to 0 conditions, and to 1 intervention - of which MS-325 Injection (Gadofosveset Trisodium) is the first listed.

NCT00459446 reports 0 study locations.

Frequently Asked Questions

What is clinical trial NCT00459446 about?

NCT00459446 is a clinical study titled "Imaging of Totally Blocked Arteries". This study will test how well a new contrast agent (dye) used in magnetic resonance imaging (MRI) can help visualize totally blocked arteries that normally supply blood to the neck, arms or legs. Currently used agents work well in visualizing normal or partly blocked arteries (arteries that have som...

What is the current status of trial NCT00459446?

This trial is currently completed. It is a Phase 1 study. The enrollment target is 20 participants. The study started on 2007-04-05.

What interventions are being tested in trial NCT00459446?

The interventions under investigation include: MS-325 Injection (Gadofosveset Trisodium) (DRUG).

Who is sponsoring clinical trial NCT00459446?

This trial is sponsored by National Heart, Lung, and Blood Institute (NHLBI), which has 501 total clinical trials registered on ClinicalTrials.gov.

Data sourced from official public datasets. See our methodology for details. Retrieved and formatted by PlainTrial Editorial

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