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van CCT (UK)


Vasa studie.


- candidate number7806
- NTR NumberNTR2239
- ISRCTNISRCTN wordt niet meer aangevraagd.
- Date ISRCTN created
- date ISRCTN requested
- Date Registered NTR1-mrt-2010
- Secondary IDs2009-381 METC Erasmus MC
- Public TitleVasa studie.
- Scientific TitleVascular contrast-enhanced ultrasound.
- ACRONYMVASA
- hypothesisPrimary Objectives:
1. A quantification method for vasa vasorum imaging using contrast-enhanced ultrasound of the carotid arteries will be developed, using physical ultrasound parameters;
2. The vessel wall thickness (intima-media thickness) and vasa vasorum will be evaluated in patients with hypertension, diabetes mellitus, hypercholesterolemia, smoking, and/or a family history of cardiovascular disease to assess the incidence and prevalence of an increased density of the vasa vasorum network;
3. A follow-up study will be performed to evaluate a relation between ultrasound parameters and prognosis.

Secondary Objective(s):
1. Side-effects will be registered;
2. Image quality and interpretability will be evaluated.

Other study parameters:
1. Demographics, gender, age, body-mass index;
2. Cardiovascular risk profile (SCORE).
- Healt Condition(s) or Problem(s) studiedHypertension, Smoking, Diabetes Mellitus, Cardiovascular risk factors, Hypercholesterolemia
- Inclusion criteria1. >18 years of age;
2. Presence of cardiac risk factors.
- Exclusion criteria1. Unstable clinical symptoms;
2. Contraindications for contrast-enhanced ultrasound.
- mec approval receivedno
- multicenter trialno
- randomisedno
- groupParallel
- TypeSingle arm
- Studytypeobservational
- planned startdate 15-mrt-2010
- planned closingdate15-mrt-2014
- Target number of participants200
- InterventionsThis is an observational study, no interventions are planned.
- Primary outcome1. A quantification method for vasa vasorum imaging using contrast-enhanced ultrasound of the carotid arteries will be developed, using physical ultrasound parameters;
2. The vessel wall thickness (intima-media thickness) and vasa vasorum will be evaluated in patients with hypertension, diabetes mellitus, hypercholesterolemia, smoking, and/or a family history of cardiovascular disease to assess the incidence and prevalence of an increased density of the vasa vasorum network;
3. A follow-up study will be performed to evaluate a relation between ultrasound parameters and prognosis.
- Secondary outcome1. Side-effects will be registered;
2. Image quality and interpretability will be evaluated.

Other study parameters:
1. Demographics, gender, age, body-mass index;
2. Cardiovascular risk profile (SCORE).
- TimepointsEach year differences between patients with and without vasa vasorum will be anallyzed.
- Trial web siteN/A
- statusplanned
- CONTACT FOR PUBLIC QUERIESMD. PhD. Arend F.L. Schinkel
- CONTACT for SCIENTIFIC QUERIESMD. PhD. Arend F.L. Schinkel
- Sponsor/Initiator Erasmus Medical Center
- Funding
(Source(s) of Monetary or Material Support)
Erasmus Medical Center
- PublicationsN/A
- Brief summaryAtherosclerosis is a progressive chronic inflammatory disease that may be complicated by cardiovascular events. Early identification of atherosclerosis is important to start treatment (for example with statins) at an early point in the disease cycle. The formation of microvessels within the vessel wall and plaque could be used as an early sign of atherosclerosis and plaque vulnerability. Barger et al initially described the possible role of vasa vasorum, the microvessels that nourish the vessel wall, in the development of atherosclerosis. Recently, several non-invasive imaging techniques have become available for detecting vasa vasorum. Contrast-enhanced ultrasound imaging of the carotid arteries is perhaps the most promising imaging modality, because of its high spatial and temporal resolution. Contrast-enhanced ultrasound is safe, and the repeatability of recording, and cost provide an incentive to develop approaches using this modality. The broad long-term goal of the proposed effort is to develop a widely available, simple, cost-effective technology to screen populations considered to be at risk of future cardiovascular events. Another broad goal of the proposal is to investigate the role of increased neovascularization (vasa vasorum) within the arterial wall. Through the development and validation of a non-invasive, ultrasound-based imaging, we will provide a method for the early detection of atherosclerosis in individuals considered to be at risk for a future cardiovascular event.
- Main changes (audit trail)
- RECORD1-mrt-2010 - 21-mrt-2010


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