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 Infarctio

• Conditions: myocardial infarction

• Registration Number: EUCTR2004-004084-29-DE
• Lead Sponsor: Bracco ALTANA Pharma GmbH

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2005-09-08
• Last Update Posted: 19 March 2012

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: Not specified

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)

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified