search  
 


Home

Who are we?

Why
register?


Signup for
registration


Online registration

Log in to register
your trial


Search a trial

NRT en CCMO

Contact

NEDERLANDS





MetaRegister
van CCT (UK)


ISRCTN-Register
van CCT (UK)


Glycocalyx measurements in people with premature cardiovascular disease.


- candidate number5256
- NTR NumberNTR1679
- ISRCTNISRCTN wordt niet meer aangevraagd
- Date ISRCTN created
- date ISRCTN requested
- Date Registered NTR3-feb-2009
- Secondary IDs09-3-001 MEC AZM/UM Maastricht
- Public TitleGlycocalyx measurements in people with premature cardiovascular disease.
- Scientific TitleNon-invasive glycocalyx measurements in premature atherosclerosis.
- ACRONYMN/A
- hypothesisThe pathophysiology of premature atherosclerosis is poorly understood. Patients often display few risk factors, but the clinical manifestations are evident. If atherosclerosis is expressed at a very young age, it is likely that besides the classical risk factors there are also genetic factors that play an important role. Therefore, early detection of vascular changes would make it possible to identify unaffected subjects at risk for atherosclerosis. One of these early vascular alterations might be the changes of the vascular glycocalyx, which is a new component of the vasculature and as been associated with surrogate endpoints of cardiovascular disease. We therefore, hypothesize that glycocalyx volume is diminished in subjects with premature atherosclerosis. Nitroglycerine (NTG) will allow differentiation between a normal thick glycocalyx in healthy individuals and pathophysiolically swollen glycocalyx, which is instable, and hyperdynamic, in the subjects with premature atherosclerosis.
- Healt Condition(s) or Problem(s) studiedAtherosclerose, Cardiovascular disease
- Inclusion criteriaCases: Male and female.
Subjects should have premature cardiovascular disease, which will be defined as cardiac, cerebral or peripheral vascular disease before the age of 40 years. Since a diminished glycocalyx volume is viewed as one of the first vascular alterations before overt atherosclerosis develops, we believe it is of no concern when the cardiovascular event had occurred. Furthermore, all of these subjects must have a positive family history for cardiovascular disease. This will be defined as at least one first degree or two or more second degree family members with cardiovascular disease before the age of 55 for men and before the age of 60 for women.

Controls:
Controls will be defined as healthy in case they have no cardiovascular history, such as no cardiac, cerebrovascular or peripheral artery disease and no complaints of angina, claudication or TIA and no family history for cardiovascular disease. Furthermore, they should be between the age of 35 and 55 years old.
- Exclusion criteriaCases:
Patients will be excluded if they have a positive history for hypertension, diabetes mellitus or other disease and in case of pregnancy or lactating women, if subjects are below the age of 18 years, or if subjects are unable to give informed consent.

Controls:
Controls will be excluded if they have had a myocardial infarction, CABG, PTCA, stroke, TIA or peripheral occlusive disease or complaints referring to one of these. They are also excluded if they have a positive family history for cardiovascular disease. Furthermore, they should not have a history of diabetes, hypertension, hypercholesterolemia or other disease. Besides subjects will be excluded in case of pregnancy or lactating women, if subjects are below the age of 18 years, or if subjects are unable to give informed consent.
- mec approval receivedno
- multicenter trialno
- randomisedyes
- masking/blindingNone
- controlActive
- groupParallel
- Type2 or more arms, randomized
- Studytypeintervention
- planned startdate 1-mei-2009
- planned closingdate1-mei-2011
- Target number of participants40
- InterventionsWe will measure glycocalyx volumes with sublingual OPS imaging before and after NTG administration.
- Primary outcomeThe volume of the intravascular glycocalyx, before and after NTG administration, in subjects with premature atherosclerosis before the age of 40 years as compared to healthy control subjects.
- Secondary outcomeNo secondary outcomes.
- TimepointsWe will measure the intravascular glycocalyx volume with OPS, timepoint 2 years.
- Trial web siteN/A
- statusplanned
- CONTACT FOR PUBLIC QUERIESProf. dr. H. Vink
- CONTACT for SCIENTIFIC QUERIESProf. dr. H. Vink
- Sponsor/Initiator University Maastricht (UM), Research institute CARIM
- Funding
(Source(s) of Monetary or Material Support)
Dutch Heart Foundation (Nederlandse Hartstichting)
- PublicationsN/A
- Brief summaryThe pathophysiology of premature atherosclerosis is poorly understood. Patients often display few risk factors, but the clinical manifestations are evident. If atherosclerosis is expressed at a very young age, it is likely that besides the classical risk factors there are also genetic factors that play an important role. Therefore, early detection of vascular changes would make it possible to identify unaffected subjects at risk for atherosclerosis. One of these early vascular alterations might be the changes of the vascular glycocalyx, which is a new component of the vasculature and as been associated with surrogate endpoints of cardiovascular disease. We therefore, hypothesize that glycocalyx volume is diminished in subjects with premature atherosclerosis. The subjects will be included in the Netherlands.
- Main changes (audit trail)
- RECORD3-feb-2009 - 14-sep-2009


  • Indien u gegevens wilt toevoegen of veranderen, kunt u een mail sturen naar nederlands@trialregister.nl