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A Study of Gadodiamide Injection in Myocardial Perfusion Magnetic Resonance Imaging

NCT00977093 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 533

Last updated 2009-09-15

No results posted yet for this study

Summary

The purpose of this study is to determine how well perfusion cardiac magnetic resonance (MR) imaging is able to detect certain heart abnormalities, such as a coronary artery narrowing.

To this purpose, a conventional MR contrast medium (Gd-DTPA-BMA) will be used during an adenosine infusion (an approved substance which enlarges the arteries of the heart, so that the blood flow to the heart muscle increases). This magnetic resonance imaging technique will be compared with single photon emission computed tomography (SPECT), a well-established technique to detect this heart abnormalities.

Both, cardiac MR and SPECT will be compared with invasive coronary angiography, a technique which directly visualized the heart vessels and narrowings of these (=standard of reference).

Conditions

Interventions

OTHER

Perfusion CMR for detection of coronary artery disease

Perfusion CMR is performed during adenosine infusion for vasodilation (3 minutes of 0.14mg/kg/min IV) and injection of Gd-DTPA-BMA at 0.075mmol/kg IV.

OTHER

Perfusion cardiac magnetic resonance imaging

Perfusion CMR with Gd-DTPA-BMA to detect coronary artery disease

Sponsors & Collaborators

  • Beacon Bioscience, Inc.

    collaborator INDUSTRY

  • The Cleveland Clinic

    collaborator OTHER

  • CRL, Medinet Europe, Breda, The Netherlands (Corelab for blood sample analyses)

    collaborator UNKNOWN

  • Biomedical Systems

    collaborator INDUSTRY

  • Amersham Buchler, GmbH & Co KG

    lead INDUSTRY

Principal Investigators

  • Karoline Meurer, Med Vet · Amersham Buchler GmbH & Co. KG, Ismaning b. Muenchen, Germany

Study Design

Allocation
NA
Purpose
DIAGNOSTIC
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2003-07-31
Primary Completion
2004-06-30
Completion
2004-06-30

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Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00977093 on ClinicalTrials.gov