Rupture of a thrombotic plaque within a coronary artery leads to a complete or incomplete occlusion of the vessel with subsequent ischemia in the affected myocardium. If not revascularised within the first 6 hours irreversible necrosis follows acute ischemia with feared complications such as heart rhythm disorders or progressive heart failure. Thus, accurate diagnosis of infarct size and extent is an important task in cardiovascular medicine.
Conditions
Sponsors
Medizinsiche Fakultät der Technischen Universität München
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: inclusion criteria • Diagnosis of or chronic myocardial infarction • Informed consent • Age over 18 years and under 80 years 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: exclusion criteria • Age under 18 years and over 80 years • Absence of an informed consent • Patients with a heart pacemaker, with magnetic material or magnetic implants • Renal failure with GFR < 30ml/min • Patients with known allergy to a Gadolinium-containing contrast agent • Drugs or alcohol addiction
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: Diagnosis of Myocardial Infarction (MI) is usually based on cardiac enzymes and ECG changes. However exact extent of myocardial infarction and transmurality can only be visualized with high resolution delayed contrast enhancement MRI. Due to the risk of nephrogenic systemic fibrosis in patients with renal failure, extravascular standard contrast agents like gadopentetate dimeglumine have to be replaced by macrocyclic contrast agents like gadobutrol or gadobenate dimeglumine. However a contrast agent with a higher molarity or a protein-binding character can cause a reduced contrast between small subendocardial infarcts and the adjacent ventricular blood pool because of the high signal-intensity in the blood pool compared to extravascular standard contrast agents. Contrast to noise ratios (CNRs) between the infarct and the left ventricular cavity as well as between the infarct and the normal myocardium will be compared between gadobutrol versus gadobenat dimeglumin, at simular dose;Secondary Objective: 2 Secondary objective: To compare signal to noise ratio (SNR) of infarct, normal myocardium and left ventricular cavity of both contrast agents ;Primary end point(s): Primary endpoints • Comparison of CNR infarct/left ventricular cavity for gadobutrol and gadobenate dimeglumine at a comparable dose (0.1 mmol/kg) • Comparison of CNR infarct/normal myocardium gadobutrol and gadobenate dimeglumine (0.1 mmol/kg) | — |
Countries
Germany
Outcome results
None listed