A reproducibility study of novel noninvasive multimodal imaging techniques in atherosclerosis in healthy and cardiovascular diseased subjects
- Conditions
- Atherosclerosiscardiovascular disease10003216
- Registration Number
- NL-OMON41660
- Lead Sponsor
- Academisch Medisch Centrum
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 60
Group A: 20 subjects with cardiovascular disease.
-Aged 40 years or older
-Known with either
a)A history of cardiovascular disease, such as but not limited to transient ischemic attack (TIA), ischemic stroke, unstable angina pectoris, myocardial infarction or peripheral artery disease.
b)Cardiovascular risk factors, such as but not limited to hypertension, diabetes mellitus, hypercholesterolemia (LDL > 4.0 mmol/l), low HDL-cholesterol (<1.03 mmol/l), smoking, obesity (BMI > 27 kg/m2).;Group B: 20 young healthy volunteers
-Aged 40-55 years
-No history of cardiovascular disease
-No cardiovascular risk factors ;Group C: 20 older healthy volunteers
-Aged 55-75 years
-No history of cardiovascular disease
-No cardiovascular risk factors
Exclusion criteria for all subjects;1. Known systemic disorders such as hepatic, renal, hematologic, and malignant diseases or any clinically significant medical condition that could interfere with the conduct of the study in the opinion of the investigator.
2. Standard contra-indications to MRI, 18F-FDG PET, and CT based on physicians experience and current practices (e.g. claustrophobia, metal in the body, as a result of e.g. osteosynthetic material, pacemaker implantation or artificial cardiac valves).
3. Inability or unwillingness to comply with the protocol requirements, or deemed by investigator to be unfit for the study.;Exclusion criteria for group A: Cardiovascular patients;1. Changes in dose or frequency of doses of lipid-lowering drugs, antihypertensive drugs or antidiabetic drugs.in the last 6 weeks prior to baseline measurements.
2. Cardiovascular event in the last 3 months prior to baseline measurements.;Exclusion criteria for group B and C: Healthy volunteers;1. A history of cardiovascular disease
2. A known elevated risk for cardiovascular disease
3. Use of any cardiovascular medication, including but not limited to lipid-lowering therapy, antihypertensive drugs, antidiabetic drugs, platelet aggregation inhibitors and anticoagulants.
Study & Design
- Study Type
- Observational invasive
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method <p>-Intraclass correlation coefficient and coefficient of variation of the<br /><br>interscan, interreader and intrareader measurements of vessel wall dimensions<br /><br>(total wall volume, mean wall area, mean wall thickness, normalized walll<br /><br>index), wall shear stress and vessel wall permeability (k-trans and area under<br /><br>the curve) by (DCE-)MRI.<br /><br>-Intraclass correlation coefficient of the interscan, interreader and<br /><br>intrareader measurements of vessel wall inflammation (TBR) by 18F-FDG PET/CT.</p><br>
- Secondary Outcome Measures
Name Time Method <p>-Difference between vessel wall dimensions (total wall volume, mean wall area,<br /><br>mean wall thickness, normalized walll index measured by MRI), wall shear stress<br /><br>(measured by MRI), vessel wall permeability (k-trans, area under the curve<br /><br>measured by DCE-MRI) and vessel wall inflammation (TBR measured by 18F-FDG<br /><br>PET/CT) between healthy young and healthy older and cardiovascular subjects.<br /><br>-Pearson*s correlation between vessel wall inflammation as measured by 18F-FDG<br /><br>-PET/CT (TBR), MRI (wall shear stress), DCE-MRI (k-trans, AUC) and laboratory<br /><br>markers of systemic inflammation (CRP, LpPLA2).</p><br>