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Comparative evaluation of different CMR pulse-sequences with respect to their practicability and diagnostic performance in diagnosing the inflamed myocardium in patients with acute myocardial infarction based on the detection of macrophages in the infarcted myocardium using Resovist® and FerahemeTM

Comparative evaluation of different CMR pulse-sequences with respect to their practicability and diagnostic performance in diagnosing the inflamed myocardium in patients with acute myocardial infarction based on the detection of macrophages in the infarcted myocardium using Resovist® and FerahemeTM

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
EU CTR
Registry ID
EUCTR2008-008936-10-DE
Enrollment
Unknown
Registered
2009-01-12
Start date
2009-03-16
Completion date
Unknown
Last updated
2015-07-10

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Patients with acute myocardial infarction MedDRA version: 9.1 Level: LLT Classification code 10000891 Term: Acute myocardial infarction

Interventions

Trade Name: Resovist Pharmaceutical Form: Intravenous infusion Trade Name: Magnevist Pharmaceutical Form: Intravenous infusion Trade Name: FerahemeTM Product Name: FerahemeTM Product Code: 59338-775

Sponsors

Division of Cardiology, Robert-Bosch-Krankenhaus
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: - acute STEMI or NSTEMI (minimally 2d to maximally 7d before the scheduled CMR imaging) - age >18 yrs - coronary artery disease - myocardial infarction detected by contrast-imaging with gadolinium-based compounds - ability to give written 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: - contraindications to magnetic resonance imaging - contraindications to Resovist/Feraheme - asthma / allergic predisposition

Design outcomes

Primary

MeasureTime frame
Main Objective: To demonstrate that the myocardial (peri-) infarct zone can be non-invasively and accurately detected by cardiovascular magnetic resonance imaging following Resovist/Feraheme application;Secondary Objective: To find out which magnetic resonance pulse-sequence are more appropriate (T2- and T2*-weigthed vs. T1-weighted imaging) in the detection of infarcted myocardium following Resovist/Feraheme application;Primary end point(s): To demonstrate that the myocardial (peri-) infarct zone can be non-invasivelydetected by cardiovascular magnetic resonance imaging following Resovist/Feraheme application as accurate as can be done with the established contrast-imaging following the application of gadolinium-based compounds—

Countries

Germany

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026