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The Innate Immune System in Atherosclerosis

Completed
Conditions
arterial wall thickening
atherosclerosis
10012653
10003816
10003216
Registration Number
NL-OMON40196
Lead Sponsor
Academisch Medisch Centrum
Brief Summary

Not available

Detailed Description

Not available

Recruitment & Eligibility

Status
Completed
Sex
Not specified
Target Recruitment
240
Inclusion Criteria

Group A: 40 Healty control subjects
- Aged 18 years or older;Group B: 40 Chronic kidney disease (CKD) patients
- Aged 18 years or older
- 20 CKD stages 3 and 4 (GFR: 15-60 ml min-1) and
- 20 Kidney transplant donors with GFR: 15-60 ml min-1 for a duration of at least 3 months
- Non inflamed (CRP <10);Group C: 20 patients with rheumathoid artritis, currently in remission as assessed by disease activity score <2,6
- Aged 18 years or older
- Non inflamed (CRP <10);Group D: 30 patients with peripheral artery disease defined as: EA-index < 0,9 and validated PAD with echo duplex, divided into 3 groups:
- 10 patients without DM2
- 10 patients with DM2 on oral glucose lowering therapy only
- 10 patients with DM2 on oral glucose lowering therapy and insulin
- Aged 18 years or older
- Non inflamed (CRP <10);Group E:
60 patients with a diagnosis of hypercholesterolemia, consisting of 3 subgroups
- 20 subjects currently not on statin therapy
- 20 subjects on stable statin therapy (at least 3 months) with LDL levels on target
- 20 subjects on stable statin therapy (at least 3 months) with LDL levels not on target
- Aged 18 years or older
- Non inflamed (CRP <10)

Exclusion Criteria

Exclusion criteria for all subjects
- Known malignant disorders or any clinically significant medical condition that could interfere with the conduct of the study in the opinion of the investigator.
- Inability or unwillingness to comply with the protocol requirements, or deemed by investigator to be unfit for the study.
- Clinical signs of acute infection and/or CRP>10;Exclusion criteria for group B: Chronic Kidney Disease
- Diabetic nephropathy
- History of MI/Stroke;Exclusion criteria for group C: Rheumatoid artitis
- History of MI/Stroke;Exclusion criteria for group D: Peripheral artery disease
- MI/Stroke in the last 12 months;Exclusion criteria for group E: Hypercholesterolemia
- MI/Stroke in the last 12 months

Study & Design

Study Type
Observational invasive
Study Design
Not specified
Primary Outcome Measures
NameTimeMethod
<p>The main study parameters are the trans endothelial migration capability and<br /><br>subtyping of monocytes in relation to underlying disease (activity). </p><br>
Secondary Outcome Measures
NameTimeMethod
<p>Other important study parameters include epigenetic changes of monocytes and<br /><br>differences in cytokine production after stimuli.</p><br>
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