Patients with a history of chronic myocardial infarction due to coronary artery disease and a successful LGE-CMR scan.
Conditions
Interventions
Trade Name: Gadovist 1.0mmol/ml
Pharmaceutical Form: Solution for injection
CAS Number: 138071-82-6
Other descriptive name: GADOBUTROL
Concentration unit: mmol/ml millimole(s)/millilitre
Concentratio
Sponsors
ClinTrio Ltd.
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: - Patients between 18 and 80 years of age - Chronic myocardial infarction based on a coronary artery disease, detected by cardiac catheterization - Successfully performed clinical LGE CMR study within the last 4 weeks for chronic myocardial infarction (> 3 months old) - Evidence of single myocardial infarction on LGE CMR with ?hyper-enhancement? involving at least 2 contiguous short-axis slices - 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: - History of moderate or severe impairment of renal function or glomerular filtration rate (GFR) <30 ml/min/m2 on blood test - Additional myocardial infarction or acute coronary syndrome during the last 4 weeks - History of other myocardial disease such as hypertrophic cardiomyopathy, myocarditis - known allergy to contrast agents containing gadolinium
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Secondary Objective: To assess the contrast kinetics of gadobutrol in infarcted and in remote myocardium.;Primary end point(s): The accuracy of Late Gadolinium Enhancement (LGE) viability Cardiac Magnetic Resonance (CMR) imaging using reduced doses of gadobutrol.;Main Objective: To determine the accuracy of Late Gadolinium Enhancement (LGE) viability Cardiac Magnetic Resonance (CMR) imaging using reduced doses of gadobutrol. | — |
Countries
Germany
Outcome results
None listed