MedPath

Waveform Analysis for Vascular Evaluation and Cardiovascular Advancements in Research and Enhancement

Recruiting
Conditions
valvular heart diseases and aneurysms (or dilation of a blood vessel)
10046973
10007593
10002363
Registration Number
NL-OMON56849
Lead Sponsor
Academisch Medisch Centrum
Brief Summary

Not available

Detailed Description

Not available

Recruitment & Eligibility

Status
Recruiting
Sex
Not specified
Target Recruitment
800
Inclusion Criteria

- >18 years of age - informed consent - diagnosed with valvular heart disease
or thoracic aortic aneurysm for surgerical procedure - scheduled for coronary
artery bypass grafting with good left ventrical function

Exclusion Criteria

Subjects of which the non-invasive blood pressure cannot be measured with the
finger cuff according to the Instruction for Use of the CS/EV1000 system

Study & Design

Study Type
Observational non invasive
Study Design
Not specified
Primary Outcome Measures
NameTimeMethod
<p>The primary endpoint of the study is to assess whether the non-invasive<br /><br>arterial pressure waveform measured at the finger level exhibits any<br /><br>distinctive morphological characteristics. In particular, analysis will be<br /><br>focused on the following characteristics:<br /><br><br /><br>· Prolongation of the total duration of ejection: systolic phase of the<br /><br>reconstructed aortic pressure waveform<br /><br><br /><br>· Prolongation of the systolic upstroke time<br /><br><br /><br>· The slope of the pressure rise during systole: dP/dt<br /><br><br /><br>· The presence and position of the anacrotic and dicrotic notches<br /><br><br /><br>· Alterations of the shape of the pulse contour<br /><br><br /><br>· Increase of time-constant of the diastolic phase of the waveform<br /><br><br /><br>· The presence of the high-frequency components in the reconstructed aortic<br /><br>pressure waveform<br /><br><br /><br>· Reduction in pulse pressure</p><br>
Secondary Outcome Measures
NameTimeMethod
<p>- Differences in accuracy of the model between males and females<br /><br><br /><br>- Differences in the accuracy of the model related to the cause of thoracic<br /><br>aortic aneurysm such as genetic or age related </p><br>
© Copyright 2025. All Rights Reserved by MedPath