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A reproducibility study of novel noninvasive multimodal imaging techniques in atherosclerosis in healthy and cardiovascular diseased subjects

A reproducibility study of novel noninvasive multimodal imaging techniques in atherosclerosis in healthy and cardiovascular diseased subjects - VISUALIZE

Status
Active, not recruiting
Phases
Unknown
Study type
Observational
Source
NL-OMON
Registry ID
NL-OMON41660
Enrollment
60
Registered
2013-07-04
Start date
2013-10-04
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

Sponsors

Academisch Medisch Centrum
Lead Sponsor

Eligibility

Age
18 Years to 99 Years

Inclusion criteria

Inclusion criteria: 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 ( 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

Exclusion criteria: 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.

Design outcomes

Primary

MeasureTime frame
-Intraclass correlation coefficient and coefficient of variation of the interscan, interreader and intrareader measurements of vessel wall dimensions (total wall volume, mean wall area, mean wall thickness, normalized walll index), wall shear stress and vessel wall permeability (k-trans and area under the curve) by (DCE-)MRI. -Intraclass correlation coefficient of the interscan, interreader and intrareader measurements of vessel wall inflammation (TBR) by 18F-FDG PET/CT.

Secondary

MeasureTime frame
-Difference between vessel wall dimensions (total wall volume, mean wall area, mean wall thickness, normalized walll index measured by MRI), wall shear stress (measured by MRI), vessel wall permeability (k-trans, area under the curve measured by DCE-MRI) and vessel wall inflammation (TBR measured by 18F-FDG PET/CT) between healthy young and healthy older and cardiovascular subjects. -Pearson*s correlation between vessel wall inflammation as measured by 18F-FDG -PET/CT (TBR), MRI (wall shear stress), DCE-MRI (k-trans, AUC) and laboratory markers of systemic inflammation (CRP, LpPLA2).

Countries

Netherlands

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)