A Study of Gadodiamide Injection in Myocardial Perfusion Magnetic Resonance Imaging (MR-IMPACT-II)
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).
|Coronary Artery Disease||Other: Perfusion CMR for detection of coronary artery disease Other: Perfusion cardiac magnetic resonance imaging||Phase 3|
|Study Design:||Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
|Official Title:||A Multicenter, Phase III, Open-label Study of Gadodiamide Injection in Myocardial Perfusion Magnetic Resonance Imaging|
- Non-inferiority of perfusion CMR vs SPECT for sensitivity and specificity (binary reading) for the detection of coronary artery disease [ Time Frame: SPECT and invasive angiography are performed within 4 weeks before or after CMR ]
- Assessment of the diagnostic performance of CMR and SPECT expressed as area under the receiver operator characteristics curve to detect coronary artery disease [ Time Frame: SPECT and invasive angiography are performed within 4 weeks before or after CMR ]
|Study Start Date:||July 2003|
|Study Completion Date:||June 2004|
|Primary Completion Date:||June 2004 (Final data collection date for primary outcome measure)|
Experimental: Perfusion CMR examination
All patients will undergo perfusion CMR examination, single-photon emission computed tomography, and conventional invasive coronary angiography.
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 OmniscanOther: 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
Please refer to this study by its ClinicalTrials.gov identifier: NCT00977093
|Study Director:||Karoline Meurer, Med Vet||Amersham Buchler GmbH & Co. KG, Ismaning b. Muenchen, Germany|