This study aims to develop a RI using CTA-based CFD simulations for estimating the hemodynamic significance across mesenteric arterial stenoses (MAS).
ID
Source
Brief title
Condition
- Arteriosclerosis, stenosis, vascular insufficiency and necrosis
- Gastrointestinal stenosis and obstruction
Synonym
Research involving
Sponsors and support
Intervention
- Other intervention
N.a.
Outcome measures
Primary outcome
<p>To develop RI by CTA-based CFD simulations for estimating hemodynamic significance across MAS.</p>
Secondary outcome
<p>To compare the sensitivity and specificity of RI in predicting definitive diagnosis of CMI to traditional parameters, such as pre-revascularization doppler ultrasound, CTA geometry information (stenosis degree), and intra-arterial pressure measurements.</p>
Background summary
Chronic mesenteric ischemia (CMI) is an incapacitating disease with a vast impact on quality of life due to severe abdominal pain after a meal, resulting in fear of eating and subsequent weight loss. CMI is most frequently caused by an atherosclerotic mesenteric artery stenosis, which is a frequent finding in the general population (6-29%). However, a mesenteric artery stenosis (MAS) is often asymptomatic. CMI is less prevalent then the prevalence of a MAS probably due to an extensive collateral circulation protecting the gut against ischemia. Especially in patients with multivessel disease revascularization treatment is recommended. Yet, substantial treatment failure (27-31% in patients with single vessel disease) is still a problem, probably since not every significant stenosis on CT leads to a hemodynamic significance due to the collateral network. In this study, this hypothesis will be tested by using computational fluid dynamics (CFD) simulations based on the Navier-Stokes equation to assess the hemodynamic significance of MAS, regardless of outflow conditions, by developing a novel resistance index (RI) in a previous retrospective study where the pressure drop over a stenosis was measured. The computational pressure measurements will be compared to the measured intra-arterial pressure measurements.
Study objective
This study aims to develop a RI using CTA-based CFD simulations for estimating the hemodynamic significance across mesenteric arterial stenoses (MAS).
Study design
Patients who were included in a previous already published study (MEC-2018-1265) are eligible in this study. In this retrospective study patients were included who underwent a digital subtraction angiography (DSA) with intended revascularization of a stenotic mesenteric artery because with a consensus diagnosis of chronic mesenteric ischemia (CMI). During this revascularization intra-arterial pressure measurements before and after intra-arterial administration of nitroglycerin had been obtained. Between April 2015 and May 2017, a total of 37 patients were included and 41 intra-arterial pressure measurements were done. This study is published in the Journal of Vascular and Interventional Radiology in March 2020.
Intervention
Not applicable
Study burden and risks
This study poses no burden to the patients as it consists solely of respective review of their (electronic) patient records and CTA images.
E.K. Bocharewicz
Dr. Molewaterplein 40
Rotterdam 3015GD
Netherlands
0652216196
e.bocharewicz@erasmusmc.nl
E.K. Bocharewicz
Dr. Molewaterplein 40
Rotterdam 3015GD
Netherlands
0652216196
e.bocharewicz@erasmusmc.nl
Listed location countries
Age
Inclusion criteria
Patients who were included in the previous study (MEC-2018-1265)
Exclusion criteria
CTA slice thickness ≥ 5 mm
Design
Recruitment
Medical products/devices used
IPD sharing statement
Plan description
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 |
|---|---|
| Research portal | NL-009233 |