The use of Iron oxide as a blood contrast agent for cardiac magnetic resonance imaging.

The use of intravenous Iron oxide as a contrast agent for cardiac magnetic resonance imaging.

Status

Not yet recruiting

Phases

Unknown

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2014-002455-26-SE

Enrollment

Unknown

Registered

2014-07-24

Start date

2014-09-20

Completion date

Unknown

Last updated

2015-08-17

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

Conditions

Cardiovascular diseases: Acute myocardial infarction, chronic myocardial infarction, myocardial ischemia, myocarditis, diffuse myocardial fibrosis.

Interventions

Trade Name: Ferinject Pharmaceutical Form: Injection INN or Proposed INN: FERRIC CARBOXYMALTOSE CAS Number: 9007-72-1

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: Healthy volunteers and patients with myocardial infarction, myocarditis, diffuse myocardial fibrosis and cardiac amyloidosis as determined by cardiovascular magnetic resonance imaging. 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 210 F.1.3 Elderly (>=65 years) no F.1.3.1 Number of subjects for this age range

Exclusion criteria

Exclusion criteria: Contraindication for MRI: Metallic subjects, inoperable medical devises, inoperable clips, brain stimulator, implantable cochlear devices, metallic foreign bodies in the eye

Design outcomes

Primary

Measure	Time frame
Main Objective: 1. To measure blood volume in the myocardium quantitatively in order to detect coronary heart disease which limits blood volume in the myocardium. 2. To quantify iron's effect in the myocardium and the blood after administration of ferric carboxymaltose using cardiac magnetic resonance imaging (T1 and ECV mapping) to quantitatively measure diffuse and focal pathological processes in the heart. 3. To replace gadolinium contrast with ferric carboxymaltose contrast for detecting cardiovascular diseases in cases where gadolinium is contraindicated. ;Secondary Objective: Not applicable;Primary end point(s): Myocardial extracellular volume and partition coefficient calculated from T1 changes in myocardium and blood after adjustment to blood extra cellular volume (1-hematocrit). ;Timepoint(s) of evaluation of this end point: Not applicable	—

Measure

Time frame

Main Objective: 1. To measure blood volume in the myocardium quantitatively in order to detect coronary heart disease which limits blood volume in the myocardium. 2. To quantify iron's effect in the myocardium and the blood after administration of ferric carboxymaltose using cardiac magnetic resonance imaging (T1 and ECV mapping) to quantitatively measure diffuse and focal pathological processes in the heart. 3. To replace gadolinium contrast with ferric carboxymaltose contrast for detecting cardiovascular diseases in cases where gadolinium is contraindicated. ;Secondary Objective: Not applicable;Primary end point(s): Myocardial extracellular volume and partition coefficient calculated from T1 changes in myocardium and blood after adjustment to blood extra cellular volume (1-hematocrit). ;Timepoint(s) of evaluation of this end point: Not applicable

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Secondary

Measure	Time frame
Secondary end point(s): Not applicable;Timepoint(s) of evaluation of this end point: Not applicable	—

Countries

Sweden

Contacts

Public ContactKarolinska University Hospital

Karolinska Institute

martin.ugander@gmail.com

Outcome results

None listed

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

The use of Iron oxide as a blood contrast agent for cardiac magnetic resonance imaging.

Conditions

Related papers

Interventions

Sponsors

Eligibility

Inclusion criteria

Exclusion criteria

Design outcomes

Primary

Secondary

Countries

Contacts

Outcome results