The use of Rienso, an ultrasmall superparamagnetic particle of iron-oxide, as a MRI contrast agent to image inflammation in the atherosclerotic plaque.

Completed

Conditions: Atherosclerosis
cardiovascular disease
10003216

Registration Number: NL-OMON43715

Lead Sponsor: Academisch Medisch Centrum

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Completed

Sex: Not specified

Target Recruitment: 60

Inclusion Criteria

Eligible are patients with either established cardiovascular disease or patients with a known elevated cardiovascular risk. Furthermore, age-matched healthy controls will be included.;Established cardiovascular disease (one or more of the following)
- Coronary artery disease (e.g. myocardial infarction, angina pectoris, ischemic heart disease)
- Carotid artery disease, previous stroke or transient ischemic attack
- Aortic aneurysm
- Peripheral artery disease;Elevated cardiovascular risk (one or more of the following)
- BMI > 27
- Metabolic syndrome
- Diabetes mellitus type II
- Hypertension (systolic blood pressure > 140 mmHg, diastolic blood pressure > 90 mmHg)
- Reduced high-density lipoprotein (<1.03 mmol/l)
- Elevated low-density lipoprotein (> 4.0 mmol/l);Healthy controls
- Aged 40-80 years.
- No cardiovascular risk factors.

Exclusion Criteria

Active inflammatory diseases
History of anaphylaxis or other hypersensitivity reactions
History of iron overload
History of renal failure or decreased renal function (eGFR <60 ml/min)
History of abnormal liver function, or elevated liver enzymen (ALAT, ASAT > 3 times the upper limit of normal).
Claustrophobia
Metal-containing material in the body or attached to the body
Planned diagnostic MRI scan in the next 6 months.

Study & Design

Study Type: Observational invasive

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>The main endpoint of this study is mean change in T2 and T2* at the level of<br /><br>the vessel wall on MRI 24 hours after the administration of Rienso.</p><br>

Secondary Outcome Measures

Name	Time	Method
<p>Secondary study parameters include<br /><br>- Parameters of vessel wall permeability (k-trans and AUC measured by DCE-MRI).<br /><br>- Circulating markers of inflammation (e.g. CRP, LpPLA2).<br /><br>- Cardiovascular risk (previous cardiovascular event, hypertension,<br /><br>hypercholesterolemia, diabetes mellitus, obesisty, smoking status, family<br /><br>history).</p><br>