To establish the accuracy and precision of systolic cardiac time intervals and arterial pulse wave velocity as obtained from multiple M-mode carotid artery ultrasonography. And to test whether the non-invasive tonometer pressure waveform is…
ID
Source
Brief title
Condition
- Coronary artery disorders
- Arteriosclerosis, stenosis, vascular insufficiency and necrosis
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
Arterial pulse wave velocity (PWV), arterial distensibility, and left
ventricular isovolumic contraction and ejection durations in a cohort with
overt cardiovascular disease; agreement between non-invasive (ultrasonographic
and tonometric) and invasive (gold standard) methods.
Secondary outcome
Details medical file: blood pressure measured in out-patient clinic
Background summary
Cardiovascular events, such as heart attacks and stroke, are secondary to
chronic processes that alter cardiac and vascular structure and function
(remodelling). Early recognition of underlying adverse remodelling is key in
combating cardiovascular disease and the associated morbidity and
socio-economic burden. Screening and timely diagnosis of cardiovascular disease
in the general population requires accurate, reproducible, and applicable
(non-invasive) assessment methods and technology. Non-invasive methods need to
be validated against (invasive) gold standards in a relevant clinical
population.
Study objective
To establish the accuracy and precision of systolic cardiac time intervals and
arterial pulse wave velocity as obtained from multiple M-mode carotid artery
ultrasonography. And to test whether the non-invasive tonometer pressure
waveform is comparable to the invasively measured pressure waveform.
Study design
Prospective observational cross-sectional study involving paired measurements
within subjects.
Study burden and risks
Study is group-related in the sense that the experimental/technical
requirements are met by the clinical diagnostic protocol. In other populations
these measurements are not performed or not simultaneously, or obtained with
insufficient measurement accuracy, are subject to intolerable variability or
extreme pharmacological or mechanical control (surgery), or are deemed
unethical in terms of risks and discomfort. Patients have to allow the
ultrasonographer to perform imaging of the carotid artery during the
angiographyprocedure. The additive risk and discomfort due to ultrasound
imaging of the CCA is considered negligible with respect to the normal risks
and discomfort involved in the angiographyprocedure.
Universiteitssingel 50
6229 ER Maastricht
Nederland
Universiteitssingel 50
6229 ER Maastricht
Nederland
Listed location countries
Age
Inclusion criteria
Inclusion criteria are predefined by study population: All patients referred for coronary angiography.
Exclusion criteria
Obesity precluding ultrasonic and tonometric investigation of the common carotid artery.
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 | NL19856.068.07 |