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AMBITYON STUDY: the relation between inflammation cells, immune system cells and the development of arteriosclerosis: a study with MRI in young adults.


- candidate number15386
- NTR NumberNTR4164
- ISRCTNISRCTN wordt niet meer aangevraagd.
- Date ISRCTN created
- date ISRCTN requested
- Date Registered NTR9-sep-2013
- Secondary IDsNL44603.041.13  UMC Utrecht
- Public TitleAMBITYON STUDY: the relation between inflammation cells, immune system cells and the development of arteriosclerosis: a study with MRI in young adults.
- Scientific TitleAtherosclerosis Monitoring and Biomarker measurements In the YOuNg
- ACRONYMAMBITYON
- hypothesisthe relevance of the proposed study lies in clarification of the interrelationship between biomarkers and the presence and (accelerated) progression of atherosclerosis shown with MR Imaging in young adults in order to identify individuals at highest risk of developing clinically manifest atherosclerosis.
- Healt Condition(s) or Problem(s) studiedAtherosclerosis , MRI, Biomarkers, Young adults
- Inclusion criteriano 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 criteriasubjects 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 with a known reduced kidney function (GFR< 60 ml/min)
subjects who are pregnant
- mec approval receivedno
- multicenter trialno
- randomisedno
- group[default]
- Type[default]
- Studytypeobservational
- planned startdate 1-jan-2014
- planned closingdate
- Target number of participants575
- InterventionsQuestionnaire: to obtain information regarding age, gender, race, medical history, medication use and lifestyle (smoking, alcohol consumption, dietary intake and social economic status), Physical examination: measurements of height, weight, waist circumference and blood pressure
Blood sampling: obtained for biochemical analysis including plasma glucose and lipid profile and obtained for biomarker measurements
MR Imaging (with use of gadolinium contrast agent): imaging of thoracic and abdominal aorta, left ventricle function, pulse wave velocity
- Primary outcome(a) presence and (b) rate of change in atherosclerosis over time in young adulthood (visualized with state-of the-art magnetic resonance imaging techniques) predicted by certain biomarkers of circulating cells and systemic inflammation
- Secondary outcomeaortic 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)
- Timepointsbaseline measurements: completed after 15 months measurements repeated 3 years after baseline measurements: completed after 51 months
- Trial web siteN/A
- statusplanned
- 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)
Self Funding
- PublicationsN/A
- Brief summaryRationale: the relevance of the proposed study lies in clarification of the interrelationship between biomarkers and the presence and (accelerated) progression of atherosclerosis shown with MR Imaging in young adults in order to identify individuals at highest risk of developing clinically manifest atherosclerosis
Objective: the overall objective of this project is to assess the 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 to further elucidate key drivers of clinically manifest atherosclerosis later in life Study design: a prospective, single center cohort study
Study population: The study population consists of 520 cardiovascular healthy participants between 25-35 years of age drawn from the region of Leidsche Rijn, Utrecht, the Netherlands.
Main study parameters/endpoints: the main study endpoints are twofold:
(1) the levels of markers of circulating cells that predict (a) presence and (b) rate of change in atherosclerosis (visualized with MR Imaging) over time in young adulthood to identify individuals at high risk to develop advanced atherosclerosis over classical cardiovascular risk factors;
(2) aortic wall thickness and presence of aortic plaques found at MR imaging of the thoracic and abdominal aorta
- Main changes (audit trail)
- RECORD9-sep-2013 - 29-sep-2013


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