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

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

Status

Active, not recruiting

Phases

Unknown

Study type

Observational

Source

NL-OMON

Registry ID

NL-OMON43715

Enrollment

Registered

2013-01-29

Start date

2013-02-27

Completion date

Unknown

Last updated

2024-04-29

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

Conditions

Atherosclerosis cardiovascular disease

Interventions

None listed

Eligibility

Age

18 Years to 99 Years

Inclusion criteria

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 ( 4.0 mmol/l);Healthy controls - Aged 40-80 years. - No cardiovascular risk factors.

Exclusion criteria

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 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.

Design outcomes

Primary

Measure	Time frame
The main endpoint of this study is mean change in T2 and T2* at the level of the vessel wall on MRI 24 hours after the administration of Rienso.	—

Secondary

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

Countries

Netherlands

Outcome results