Quantification of diseases in small vessels of the human myocardium - a new approach in quantification

Pathological changes in the myocardial microvasculature - a MR-based quantification - Myo-Mikro-Quant

Status

Active, not recruiting

Phases

Phase 3

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2013-003234-32-DE

Enrollment

125

Registered

2014-03-24

Start date

2014-12-02

Completion date

Unknown

Last updated

2019-02-28

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

Conditions

Patients with cardiovascular diseases and suspect of myocardial microvasculopathy

Interventions

Trade Name: Ferinject Product Name: Ferinject Product Code: ATC-Code B03AC Pharmaceutical Form: Solution for injection INN or Proposed I

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: - cardiac disease with suspected microvasculopathy (hypertension, chronic myocardial infarction, hypertrophic cardiomyopathy, post-heart transplantation, cardiac dystrophinopathy) - age >18 years - ability to give 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 125 F.1.3 Elderly (>=65 years) no F.1.3.1 Number of subjects for this age range 0

Exclusion criteria

Exclusion criteria: - contraindications to magnetic resonance imaging - contraindications to Feraheme or Magnevist - asthma / allergic predisposition - pregnancy

Design outcomes

Primary

Measure	Time frame
Main Objective: To demonstrate that pathological changes in the myocardial microvasculature can be detected and measured by cardiovascular magnetic resonance imaging following the application of Feraheme and special T2-mapping sequences;Secondary Objective: To demonstrate that this novel approach is superior to the established T1-mapping technique;Primary end point(s): To demonstrate that the intravascular volume in the myocardium can be measured non-invasively by cardiovascular magnetic resonance imaging following the application of Feraheme and special T2-mapping sequences;Timepoint(s) of evaluation of this end point: 12h to 24h after infusion of Feraheme	—

Measure

Time frame

Main Objective: To demonstrate that pathological changes in the myocardial microvasculature can be detected and measured by cardiovascular magnetic resonance imaging following the application of Feraheme and special T2-mapping sequences;Secondary Objective: To demonstrate that this novel approach is superior to the established T1-mapping technique;Primary end point(s): To demonstrate that the intravascular volume in the myocardium can be measured non-invasively by cardiovascular magnetic resonance imaging following the application of Feraheme and special T2-mapping sequences;Timepoint(s) of evaluation of this end point: 12h to 24h after infusion of Feraheme

—

Secondary

Measure	Time frame
Secondary end point(s): To demonstrate that this novel approach based on T2-mapping following infusion of Feraheme is superior to T1-mapping following infusion of Magnevist;Timepoint(s) of evaluation of this end point: 12h to 24h after infusion of Feraheme	—

Countries

Germany

Contacts

Public ContactUniv.-Prof. Dr. med. Ali Yilmaz

Department für Kardiologie und Angiologie

ali.yilmaz@ukmuenster.de

Outcome results

None listed

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