Arterial Stiffness, Blood Pressure and Cardiac Output Study

Study Overview
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Brief Summary
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Comparison of non-invasively obtained central blood pressure using SphygmoCor and invasively recorded central blood pressure in patients with an AAA that will be treated with EVAR.

Detailed Description
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Primary objective of the first study: validation of non-invasive central pressure parameters in patients treated with EVAR against invasive measurements. Objectives of subsequent studies: Do non-invasive central parameters change over time after EVAR? What is the influence of intraluminal thrombus (presence, amount, configuration) on non-invasive central pressure parameters (and other obtained parameters of arterial stiffness)? Prospective study with consecutive, eligible subject enrollment. All subjects will undergo the Endovascular Aneurysm repair procedure with an endovascular device. Subjects will be followed procedurally, at 6-8 weeks and 1 year post implantation. This study is a collaboration of the following departments of the Vascular Center in the Rijnstate Hospital Arnhem: Vascular Surgery, Interventional radiology, Internal Vascular Medicine, Cardiology. Patients diagnosed with an abdominal aortic or aortoiliac aneurysm who are considered candidates for endovascular repair and who meet the study eligibility criteria may be screened for enrollment in the study. Up to 20 subjects will be enrolled . Pre-procedural high resolution, contrast-enhanced CT scan evaluation to determine anatomical eligibility for enrollment will be performed within three months of the study procedure, according to standard care. Following EC/IRB approval of the study and the written informed consent form, patients will be screened for eligibility. Following informed consent, clinical characteristics will be reported (from hospital records). Per-procedural PWA measurements will be performed simultaneously with intravascular pressure measurements pre-implantation and after completion of the endocasular implantation. Subjects will be followed at 30 days and 1 year post-implantation.

Official Title
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Arterial Stiffness, Blood Pressure and Cardiac Output Study; ABC-study A Prospective, Multidisciplinary Study of Arterial Stiffness Measures in Patients Treated for Aortic Aneurysms in Relation to Blood Pressure and Cardiac Output

Conditions
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Infrarenal Abdominal Aortic Aneurysm

Intervention / Treatment
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* Diagnostic Test: Pulse wave analyses; central blood presaure parameters


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Male or female at least 18 years old; Informed consent form understood and signed and patient agrees to follow-up visits; Have a infrarenal abdominal aortic aneurysm (AAA) with maximum sac diameter ≥ 5.5cm, or an AAA ≥ 4.5 cm which has increased by > 1.0 cm in the past year with a scheduled endovascular intervention Exclusion Criteria: Life expectancy < 2 years; Psychiatric or other condition that may interfere with the study; Participating in another clinical study, interfering on outcomes; Irregular pulse; Presence of extensive peripheral arterial disease (ABI < 0.9 or obstruction validated on imaging); dated less than 3 months prior to treatment Ruptured, leaking or mycotic aneurysm;

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Diagnostic
Intervention Model: Single Group Assignment
Interventional Model Description: prospective,multidisciplinary single center study
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: elective EVAR patients<br>Elective EVAR patients will be included in one arm only | Diagnostic Test: Pulse wave analyses; central blood presaure parameters<br>* Pulse wave analyses; central blood presaure parameters<br>* Other names: Pulse wave velocity;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| central blood pressure | comparison of invasively recorded and non-invsively estimated central blood pressure | one week | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| changes in arterial stiffness pre- and post EVAR | changes in arterial stiffness pre- and post EVAR | 1 year | 
| influence of thrombus on arterial stiffness | influence of thrombus on arterial stiffness | 1 year | 
| changes in arterial stiffness over time | changes in arterial stiffness over time | 1 year | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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EVAR, central pressure, arterial stiffness, AAA, elective surgery