The use of Iron oxide as a blood contrast agent for cardiac magnetic resonance imaging.
- Conditions
- Cardiovascular diseases: Acute myocardial infarction, chronic myocardial infarction, myocardial ischemia, myocarditis, diffuse myocardial fibrosis.Therapeutic area: Diseases [C] - Cardiovascular Diseases [C14]
- Registration Number
- EUCTR2014-002455-26-SE
- Lead Sponsor
- Karolinska Institute
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Authorised-recruitment may be ongoing or finished
- Sex
- All
- Target Recruitment
- Not specified
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
Contraindication for MRI:
Metallic subjects, inoperable medical devises, inoperable clips, brain stimulator, implantable cochlear devices, metallic foreign bodies in the eye
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method 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.<br><br>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. <br><br>3. To replace gadolinium contrast with ferric carboxymaltose contrast for detecting cardiovascular diseases in cases where gadolinium is contraindicated. <br>;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
- Secondary Outcome Measures
Name Time Method Secondary end point(s): Not applicable;Timepoint(s) of evaluation of this end point: Not applicable