EUCTR2004-004084-29-DEActive, not recruitingNot Applicable
Intraindividual cross-over study to compare 1.5-tesla and 3.0-tesla MRI with 0.05+0.05 mmol/kgbw MultiHance® in patients with Myocardial Infarction
Bracco ALTANA Pharma GmbH0 sitesStarted: September 8, 2005Last updated:
Conditions
Drugs
Trial Snapshot
- Phase
- Not Applicable
- Status
- Active, not recruiting
- Sponsor
Study Overview
Brief Summary
No summary available.
Study Design
- Study Type
- Interventional clinical trial of medicinal product
Eligibility Criteria
- Sex
- All
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
- •- 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)
Investigators
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