Patients with a history of chronic myocardial infarction MedDRA version: 12.1 Level: LLT Classification code 10028596 Term: Myocardial infarction MedDRA version: 12.1 Level: LLT Classification code 10028598 Term: Myocardial infarction old MedDRA version: 12.1 Level: LLT Classification code 10028599 Term: Myocardial infarction old healed MedDRA version: 12.1 Level: LLT Classification code 10030272 Term: Old myocardial infarction
Conditions
Sponsors
Charité
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Adult patients, age 18 years and older 2. History of chronic myocardial infarction (echocardiography or ECG) 3. Willing to undergo and to comply with all study procedures 4. Written informed consent, self-signed and dated, voluntarily given 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: Patients 1. who are female of childbearing potential or in nursery 2. with moderate impaired renal function (GFR calculated with MDRD formula =60 mL/min/1.72m2). Serum creatinine values must not be older than 12 weeks 3. with renal transplant, including patients with scheduled renal transplantation 4. with a contraindication to MRI (e.g. pacemaker, clips, severe claustrophobia) 5. with known allergy or any contraindication to Gadovist, Magnevist and/or Dotarem 6. presenting with a history of anaphylactoid or anaphylactic reaction to any of the ingredients of the study drugs. 7. having any physical or mental status interfering with the informed consent procedure including self-signed informed consent 8. being unstable or requiring emergency treatment 9. with close affiliation with the investigational site; e.g. a close relative of the investigator 10. who have received any contrast agent within 24 hours prior to entering this study 11. who are scheduled for any therapy between any of the study procedures that may interfere with the comparability of the study procedures 12. having an underlying disease or concomitant medication which may interfere with efficacy evaluation. 13. participating in another clinical trial 14. who have previously entered this study 15. with severe cardiovascular disease (e.g. congenital or family history of QT syndrome) 16. who are for legal or regulatory reasons hospitilized in an institution
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To gain first data on the comparison of Gadovist® with Magnevist® and Dotarem® with regard to the degree of late gadolinium enhancement (LGE) in infarcted myocardium;Secondary Objective: • To assess SNR and CNR of Late Gadolinium enhancement (LGE) until 45 minutes after injection of contrast media • To assess the kinetic behaviour of LGE over 45 minutes after contrast agent injection;Primary end point(s): Infarct size on LGE images expressed as percentage of total left ventricular myocardial mass (Gadovist® vs. Magnevist® vs. Dotarem®) | — |
Countries
Germany
Outcome results
None listed