E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
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MedDRA Classification |
E.1.3 | Condition being studied is a rare disease | Information not present in EudraCT |
E.2 Objective of the trial |
E.2.1 | Main objective of the trial |
Primary objective of the present study is to prove the superiority of MultiHance® enhanced 3.0-tesla MRI compared to 1.5-tesla MRI in the contrast-to-noise ratio during the late enhancement of myocardial infarctions |
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E.2.2 | Secondary objectives of the trial |
To compare MultiHance® enhanced 3.0-tesla and 1.5-tesla late MRI with regard to: - Presence and localization of the infarction; - Extent of the infarction; - Signal intensity measurements; - Qualitative matched pairs assessments.
To compare MultiHance® enhanced 3.0-tesla and 1.5-tesla MR perfusion images with regard to: - Presence and localization of the perfusion defects.
To evaluate safety of MultiHance® application in patients with confirmed chronical myocardial infarction |
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E.2.3 | Trial contains a sub-study | Information not present in EudraCT |
E.3 | Principal inclusion criteria |
- Patients with confirmed chronical myocardial infarction (first diagnosis at least 3 months ago); - Patient's age > or = 18 years - Written Informed Consent. |
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E.4 | Principal exclusion criteria |
- Patient has a body weight > or = 120 kg; - Instable angina pectoris; - Myocardial insufficiency, NYHA grade III or IV; - Patient with known severe renal impairment or requiring dialysis; - Patient with a history of hypersensitivity to any metals or to chelates of Gadolinium; - Patient with pacemakers, ferro-magnetic material such as surgical clips or any other conditions that would preclude proximity to a strong magnetic field; - Patient is suffering from severe claustrophobia; - Patient with any medical condition or other circumstances that would significantly decrease the chances of obtaining reliable data or of achieving the study objectives, i.e.: - drug dependence - psychiatric disorder, dementia, or other reasons for expected poor compliance with investigator’s instructions, - medical conditions, associated illness, or extenuating circumstances that make it highly unlikely that the patient can complete the study;
- Patient is female and pregnant or nursing; - Patient is female and the possibility of pregnancy cannot be excluded from one of the following points: - surgical sterilization (method has to be recorded on medical history form), - confirmed post-menopausal (with minimum 1-year history without menstruation), - negative pregnancy test (confirmed via ß-HCG measurement);
- Patient is currently participating or has previously participated in a study (in which an investigational drug was dispensed) within 30 days prior to admission to this study; - Patient has previously entered this study; - Patient without legal capacity (i.e. prisoners) - Subjects with renal insufficiency (creatinine clearance < or = 30 ml/min)
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E.5 End points |
E.5.1 | Primary end point(s) |
The primary efficacy endpoint is the contrast-to-noise ratio during the late enhancement of the myocardium where contrast is the difference in signal intensity between infarcted and normal myocardium and noise is the standard deviation of the air measurement.
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E.6 and E.7 Scope of the trial |
E.6 | Scope of the trial |
E.6.1 | Diagnosis | Yes |
E.6.2 | Prophylaxis | No |
E.6.3 | Therapy | No |
E.6.4 | Safety | Yes |
E.6.5 | Efficacy | Yes |
E.6.6 | Pharmacokinetic | No |
E.6.7 | Pharmacodynamic | No |
E.6.8 | Bioequivalence | No |
E.6.9 | Dose response | No |
E.6.10 | Pharmacogenetic | Information not present in EudraCT |
E.6.11 | Pharmacogenomic | No |
E.6.12 | Pharmacoeconomic | No |
E.6.13 | Others | No |
E.7 | Trial type and phase |
E.7.1 | Human pharmacology (Phase I) | No |
E.7.1.1 | First administration to humans | No |
E.7.1.2 | Bioequivalence study | No |
E.7.1.3 | Other | No |
E.7.1.3.1 | Other trial type description | |
E.7.2 | Therapeutic exploratory (Phase II) | No |
E.7.3 | Therapeutic confirmatory (Phase III) | Yes |
E.7.4 | Therapeutic use (Phase IV) | No |
E.8 Design of the trial |
E.8.1 | Controlled | No |
E.8.1.1 | Randomised | No |
E.8.1.2 | Open | Information not present in EudraCT |
E.8.1.3 | Single blind | Information not present in EudraCT |
E.8.1.4 | Double blind | Information not present in EudraCT |
E.8.1.5 | Parallel group | Information not present in EudraCT |
E.8.1.6 | Cross over | Information not present in EudraCT |
E.8.1.7 | Other | Information not present in EudraCT |
E.8.2 | Comparator of controlled trial |
E.8.2.1 | Other medicinal product(s) | No |
E.8.2.2 | Placebo | No |
E.8.2.3 | Other | No |
E.8.3 |
The trial involves single site in the Member State concerned
| Yes |
E.8.4 | The trial involves multiple sites in the Member State concerned | No |
E.8.5 | The trial involves multiple Member States | No |
E.8.6 Trial involving sites outside the EEA |
E.8.6.1 | Trial being conducted both within and outside the EEA | No |
E.8.6.2 | Trial being conducted completely outside of the EEA | Information not present in EudraCT |
E.8.7 | Trial has a data monitoring committee | Information not present in EudraCT |
E.8.8 |
Definition of the end of the trial and justification where it is not the last
visit of the last subject undergoing the trial
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E.8.9 Initial estimate of the duration of the trial |
E.8.9.1 | In the Member State concerned years | 0 |
E.8.9.1 | In the Member State concerned months | 6 |
E.8.9.1 | In the Member State concerned days | |