The use of iron-oxide particles to image vessel wall inflammation with MRI in patients with cardiovascular disease.

• Conditions: Atherosclerosis; MedDRA version: 14.1Level: LLTClassification code 10003601Term: AtherosclerosisSystem Organ Class: 100000004866; Therapeutic area: Diseases [C] - Cardiovascular Diseases [C14]

• Registration Number: EUCTR2012-005447-25-NL
• Lead Sponsor: Academic Medical Center Amsterdam, department of Internal Medicine

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2013-02-22
• Last Update Posted: 19 August 2013

Recruitment & Eligibility

• Status: Authorised-recruitment may be ongoing or finished
• Sex: All
• Target Recruitment: Not specified

Inclusion Criteria

Patients with 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 aneurysmatic disease
- Peripheral artery disease

Patients with an 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
- Elevated low-density lipoprotein

Healthy volunteers
- Aged 40-80 years
- Not known with cardiovascular risk factors.
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 30
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 30

Exclusion Criteria

Active inflammatory diseases
History of anaphylaxis or other hypersensitivity reactions
History of iron overload
History of renal failure
History of abnormal liver function, or elevated liver enzymes.
Claustrophobia
Metal-containing material in the body or attached to the body

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified