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The relation between inflammation cells and immune-system cells and the development of hardening of the arteries (arteriosclerosis), a research project with MRI in young adults


- candidate number19318
- NTR NumberNTR4742
- ISRCTNISRCTN no longer applicable
- Date ISRCTN created
- date ISRCTN requested
- Date Registered NTR18-aug-2014
- Secondary IDsNL44603.041.13  13/397 METC UMC Utrecht
- Public TitleThe relation between inflammation cells and immune-system cells and the development of hardening of the arteries (arteriosclerosis), a research project with MRI in young adults
- Scientific TitleAtherosclerosis Monitoring and Biomarker measurements In The YOuNg
- ACRONYMAMBITYON STUDY
- hypothesisThe overall hypothesis of this project is that there is an interplay between classical risk factors, plasma markers, markers of activated circulating cells and atherosclerosis burden at MR imaging (expressed as aortic vessel wall thickness and presence of plaques) in the development of atherosclerosis in young adulthood
- Healt Condition(s) or Problem(s) studiedMRI, Arteriosclerosis, Young adults
- Inclusion criteria no medical history of cardiovascular disease and no cardiovascular preventive medication;
between 25-35 years of age;
willing and be able to sign informed consent
- Exclusion criteria subjects with claustrophobia;
subjects with a history of allergic reactions to MR contrast fluids;
subjects with implanted electronic devices (i.e. pacemaker, internal cardioverter-defibrillator, cochlear implants, nerve- and bone stimulators);
subjects with ferromagnetic clips in brain, eyes or lungs;
subjects who are known with a reduced kidney function (GFR< 60 ml/min)
subjects who are pregnant
subjects who do not wish to be informed about abnormal findings
- mec approval receivedyes
- multicenter trialno
- randomisedno
- group[default]
- TypeSingle arm
- Studytypeobservational
- planned startdate 23-apr-2014
- planned closingdate31-dec-2017
- Target number of participants520
- InterventionsAll the interventions will occur twice. One time at baseline and three years after baseline measurement (progression of atherosclerosis monitoring)
- physical examination (blood pressure measurement, height and weight measurements)
- withdraw 50 cc of venous blood (assessment of biomarkers, lipid spectrum, glucose level and white bloodcell count)
- Primary outcome-aortic wall thickness and volume;
-presence and number of aortic atherosclerotic plaques (luminal protrusion of > 1 mm in radial thickness);
-the extent of aortic atherosclerosis (expressed as % of affected aorta as fraction of total aorta depicted).
- Secondary outcome-biomarkers of circulating cells;
-plasma biomarkers of systemic inflammation (including micro particles)
- Timepoints- after first visit of participants
- after second visit of participants (three years after first visit)
- Trial web siteNA
- statusopen: patient inclusion
- CONTACT FOR PUBLIC QUERIESMD A.L.M. Eikendal
- CONTACT for SCIENTIFIC QUERIESMD A.L.M. Eikendal
- Sponsor/Initiator University Medical Center Utrecht (UMCU)
- Funding
(Source(s) of Monetary or Material Support)
ZON-MW, The Netherlands Organization for Health Research and Development
- Publications
- Brief summary
- Main changes (audit trail)
- RECORD18-aug-2014 - 8-sep-2014


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