Repeating the phantom study in human subjects will provide us the answer which of the new pulse-sequences should be used for future contrast-enhanced ultrasound studies.
ID
Source
Brief title
Condition
- Arteriosclerosis, stenosis, vascular insufficiency and necrosis
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
Lumen intensity
Artifact intensity
Secondary outcome
Differences in amount of intra-plaque neovascularization will be detected using
automated quantification software developed for the evaluation of intra-plaque
neovascularization.
Background summary
In the Erasmus Medical Center, multiple studies investigated the clinical value
of vascular contrast-enhanced ultrasound. One of the conclusions of a prior
study was that the ultrasound clips are hindered by an artifact, resulting in
ultrasound clips that are not suitable for analysis. This artifact is caused by
the way the ultrasound pulse-sequences behave in the human body. By adjusting
these sequences, a solution for this artifact could be provided. To prove that
the new pulse-sequences perform better than the current pulse-sequences, we
have to perform a observational comparison study. Such a study is allready
performed in a phantom. However, that controlled setting does not provide a
realistic view of the human neck.
Study objective
Repeating the phantom study in human subjects will provide us the answer which
of the new pulse-sequences should be used for future contrast-enhanced
ultrasound studies.
Study design
Observational study.
Study burden and risks
Ultrasound contrast agent will be administered intravenously. This ultrasound
contrast agent is safe (see references) and is registered for contrast-enhanced
echocardiography. The chance of een allergic reaction after administration of
ultrasound contrast agents is limited. During each examination, a medical
docter will be present. In case of allergic reactions he will intervein
immediately.
Main ML, Ryan AC, Davis TE, Albano MP, Kusnetzky LL, Hibberd M. Acute mortality
in hospitalized patients undergoing echocardiography with and without an
ultrasound contrast agent (multicenter registry results in 4,300,966
consecutive patients). Am J Cardiol 2008;102:1742-6.
Kusnetzky LL, Khalid A, Khumri TM, Moe TG, Jones PG, Main ML. Acute mortality
in hospitalized patients undergoing echocardiography with and without an
ultrasound contrast agent: results in 18,671 consecutive studies. J Am Coll
Cardiol 2008;51:1704-6.
Wei K, Mulvagh SL, Carson L, Davidoff R, Gabriel R, Grimm RA, e.a. The safety
of deFinity and Optison for ultrasound image enhancement: a retrospective
analysis of 78,383 administered contrast doses. J Am Soc Echocardiogr
2008;21:1202-6.
's Gravendijkwal 230
Rotterdam 3015CE
NL
's Gravendijkwal 230
Rotterdam 3015CE
NL
Listed location countries
Age
Inclusion criteria
1. Prior participation in the VASA study (ABR-number: 28698)
2. Age over 18 years
Exclusion criteria
1. Unstable clinical symptoms
2. Contraindications for contrast-enhanced ultrasound
Design
Recruitment
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| CCMO | NL42873.078.12 |