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Vascular Inflammation in Patients at Risk for Atherosclerotic Disease


- candidate number21141
- NTR NumberNTR5006
- ISRCTNISRCTN no longer applicable
- Date ISRCTN created
- date ISRCTN requested
- Date Registered NTR10-dec-2014
- Secondary IDsNL37300.018.11 
- Public TitleVascular Inflammation in Patients at Risk for Atherosclerotic Disease
- Scientific TitleA Single Center Study Evaluating the Associations Between Common Cardiovascular Risk Factors and Vascular Inflammation
- ACRONYMVIPER
- hypothesisCarotid and aortic atherosclerotic plaque inflammation can be measured by [18F]DG PET/CT in humans, and is discriminative for cardiovascular risk factors
- Healt Condition(s) or Problem(s) studiedCardiovascular disease, Atherosclerosis
- Inclusion criteriaSubjects at risk
Patients must meet the following criteria for study entry: Patients aged equal to or greater than 50 years, Patients with an increased risk for cardiovascular disease. If using a statin, on stable therapy for at least 6 weeks prior to screening with no evidence of statin intolerance. For patients taking angiotensin-converting enzyme (ACE) inhibitors (ACE-I) or angiotensin-receptor blockers (ARBs), non-statin lipid-modifying therapy, thiazolidinediones, inhaled steroids, or leukotriene modifying agents, use of a stable dose for at least 6 weeks prior to baseline measurement. Stable Nonsteroidal anti-inflammatory drugs (NSAIDS), Cyclo-oxygenase-2 inhibitors (COXIBs) for at least 6 weeks prior to baseline measurement. Subjects are not permitted any alcohol or caffeine-containing food or drinks from 12 hrs prior to study visits until discharge. In addition, no strenuous exercise is permitted for 24 hrs before the study visits.

Healthy controls
Healthy controls must meet the following criteria for study entry: Healthy subjects aged older than 50 years.
- Exclusion criteriaSubjects may not enter this study if they meet the following criteria: Current medical history of Auto-immune disease/vasculitis, active inflammatory diseases, proven or suspected bacterial infections. Recent (within 1 month prior to screening) or ongoing serious infection requiring IV antibiotic therapy. Use medication for diabetes mellitus, or an elevated blood pressure. Are known with a BMI above 28. Recent or current treatment with medications that may have a significant effect on plaque inflammation as measured by plaque TBR, including but not limited to: Steroids for at least 6 weeks prior to baseline measurement and during study (with the exception of inhaled steroids). Biological based medicines (anti-TNF (ex. Infliximab), anti-IL-6 therapy (ex. Tocilizumab) or anti-IL-1 (ex. anakinra)) within 8 weeks before the baseline visit and during the study No other Disease modifying antirheumatic drugs (DMRADS) within 6 weeks of baseline and during study (such as cyclosporine, azatioprine, etc.) Any clinically significant medical condition that could interfere with the conduct of the study. Standard contra-indications to MRI, 18FDG PET, and CT. Impaired hepatic function. Impaired renal function. Inability or unwillingness to comply with the protocol requirements, or deemed by investigator to be unfit for the study. Subject has planned cardiac surgery, PCI or carotid stenting, or major non-cardiac surgery during the course of the study period or for 14 days after the last treatment.
- mec approval receivedyes
- multicenter trialno
- randomisedyes
- masking/blindingNone
- controlActive
- groupParallel
- Type2 or more arms, non-randomized
- Studytypeobservational
- planned startdate 3-nov-2011
- planned closingdate3-nov-2015
- Target number of participants100
- InterventionsObservational study: single FDG-PET/CT and blood sampling.
- Primary outcomeDifferences in TBR between groups with specific different CVD risk factors
- Secondary outcomeAssociations between inflammatory parameters and TBR
- TimepointsSingle timepoint; observational study
- Trial web site
- statusopen: patient inclusion
- CONTACT FOR PUBLIC QUERIESMD PhD E.S.G. Stroes
- CONTACT for SCIENTIFIC QUERIESMD PhD E.S.G. Stroes
- Sponsor/Initiator Academic Medical Center (AMC), Department of Vascular Medicine
- Funding
(Source(s) of Monetary or Material Support)
Academic Medical Center (AMC), Department of Vascular Medicine
- Publications
- Brief summary
- Main changes (audit trail)
- RECORD10-dec-2014 - 15-jun-2015


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