Arterial Stiffness, Blood Pressure and Cardiac Output Study

Infrarenal Abdominal Aortic Aneurysm Clinical Trial

— ABC  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03469388
• Other study ID #: 2016-0820
• Secondary ID: NL57153.091.16
• Status: Completed
• Phase: N/A
• Start date: April 24, 2017
• Est. completion date: December 31, 2019

Study information

• Verified date: March 2020
• Source: Rijnstate Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

Description:

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 20
• Est. completion date: December 31, 2019
• Est. primary completion date: August 5, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

1. Male or female at least 18 years old;

2. Informed consent form understood and signed and patient agrees to follow-up visits;

3. 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:

1. Life expectancy < 2 years;

2. Psychiatric or other condition that may interfere with the study;

3. Participating in another clinical study, interfering on outcomes;

4. Irregular pulse;

5. Presence of extensive peripheral arterial disease (ABI < 0.9 or obstruction validated on imaging); dated less than 3 months prior to treatment

6. Ruptured, leaking or mycotic aneurysm;

Related Conditions & MeSH terms

• Aneurysm
• Aortic Aneurysm
• Aortic Aneurysm, Abdominal
• Infrarenal Abdominal Aortic Aneurysm

Intervention

Diagnostic Test:
• Pulse wave analyses; central blood presaure parameters
Pulse wave analyses; central blood presaure parameters

Locations

Country	Name	City	State
Netherlands	Rijnstate Hospital	Arnhem	Gelderland

Sponsors (1)

Lead Sponsor	Collaborator
Rijnstate Hospital

Country where clinical trial is conducted

Netherlands, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	central blood pressure	comparison of invasively recorded and non-invsively estimated central blood pressure	one week
Secondary	changes in arterial stiffness pre- and post EVAR	changes in arterial stiffness pre- and post EVAR	1 year
Secondary	influence of thrombus on arterial stiffness	influence of thrombus on arterial stiffness	1 year
Secondary	changes in arterial stiffness over time	changes in arterial stiffness over time	1 year