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| Sponsor: | Amersham Buchler, GmbH & Co KG |
|---|---|
| Collaborators: |
Beacon Bioscience, Inc. Cleveland Clinic Foundation, Cleveland, USA (Corelab for coronary angiography analysis) CRL, Medinet Europe, Breda, The Netherlands (Corelab for blood sample analyses) Biomedical Systems (BMS) Europe, Brussels, Belgium (Corelab for ECG analysis) |
| Information provided by: | Amersham Buchler, GmbH & Co KG |
| ClinicalTrials.gov Identifier: | NCT00977093 |
Purpose
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).
| Condition | Intervention | Phase |
|---|---|---|
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Coronary Artery Disease |
Other: Perfusion CMR for detection of coronary artery disease Other: Perfusion cardiac magnetic resonance imaging |
Phase III |
| Study Type: | Interventional |
| Study Design: | Endpoint Classification: Efficacy Study Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Diagnostic |
| Official Title: | A Multicenter, Phase III, Open-label Study of Gadodiamide Injection in Myocardial Perfusion Magnetic Resonance Imaging |
| Enrollment: | 533 |
| Study Start Date: | July 2003 |
| Study Completion Date: | June 2004 |
| Primary Completion Date: | June 2004 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Experimental: Perfusion CMR examination
All patients will undergo perfusion CMR examination, single-photon emission computed tomography, and conventional invasive coronary angiography.
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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 Name: MR contrast medium: Gd-DTPA-BMA is Omniscan
Other: Perfusion cardiac magnetic resonance imaging
Perfusion CMR with Gd-DTPA-BMA to detect coronary artery disease
Other Name: Conventional MR contast medium: Gd-DTPA-BMA is Omniscan
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This study is a multicentre, open label, phase III study in adult subjects designed to show that Gd-DTPA-BMA (a conventional MR contrast medium = OMNISCAN) enhanced myocardial MR perfusion imaging is non-inferior to myocardial SPECT. Both imaging techniques will be performed during adenosine stress (0.14mg/min/kg over 3 minutes IV). Gd-DTPA-BMA will be used twice (2 doses of 0.075 mmol/kg for the stress and rest study each) for the detection of myocardial perfusion defects. The standard of reference is invasive coronary angiography, which defines the presence of coronary artery disease, if vessels of at least 2mm in diameter show stenosis of at least 50% (diameter reduction). Patients with a history of myocardial infarction(s) are positive for coronary artery disease, even when coronary arteries are not stenosed as evidenced by the coronary angiography performed in the setting of this trial(= assigning patients as positive for coronary artery disease after successful PCI-revascularization of acute infarct(s) in the past).
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Contacts and Locations| Study Director: | Karoline Meurer, Med Vet | Amersham Buchler GmbH & Co. KG, Ismaning b. Muenchen, Germany |
More Information
| Responsible Party: | Prof. Juerg Schwitter, University Hospital Lausanne - CHUV, Switzerland |
| ClinicalTrials.gov Identifier: | NCT00977093 History of Changes |
| Other Study ID Numbers: | SOV 303 / SOV 304 |
| Study First Received: | September 14, 2009 |
| Last Updated: | September 14, 2009 |
| Health Authority: | United States: Institutional Review Board; European Union: European Medicines Agency |
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Coronary artery disease Cardiac magnetic resonance imaging single photon emission computed tomography invasive coronary angiography |
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Coronary Artery Disease Myocardial Ischemia Coronary Disease Heart Diseases |
Cardiovascular Diseases Arteriosclerosis Arterial Occlusive Diseases Vascular Diseases |