myocardial infarction
Conditions
Interventions
Trade Name: MultiHance®
Product Name: MultiHance®
Pharmaceutical Form: Solution for injection
INN or Proposed INN: Gadobenate Dimeglumine
CAS Number: 113662-23-0
Concentration unit: mol/l mole(s)/lit
Sponsors
Bracco ALTANA Pharma GmbH
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: - Patients with confirmed chronical myocardial infarction (first diagnosis at least 3 months ago); - Patient's age > or = 18 years - Written Informed Consent. Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range
Exclusion criteria
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)
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: 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;Secondary Objective: 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;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. | — |
Countries
Germany
Outcome results
None listed