Arterial Stiffness, Blood Pressure and Cardiac Output Study (ABC)

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

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.

Study Overview

• Status: Completed
• Conditions: Infrarenal Abdominal Aortic Aneurysm
• Intervention / Treatment: Diagnostic test: Pulse wave analyses; central blood presaure parameters

Detailed 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.

• Study Type: Interventional
• Enrollment (Actual): 20
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Netherlands
  • Gelderland
    • Arnhem, Gelderland, Netherlands, 6800 TA
      • Rijnstate Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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;

Study Plan

How is the study designed?

Design Details

• Primary Purpose: DIAGNOSTIC
• Allocation: NA
• Interventional Model: SINGLE_GROUP
• Masking: NONE

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: elective EVAR patients; Elective EVAR patients will be included in one arm only	Diagnostic test: Pulse wave analyses; central blood presaure parameters; Pulse wave analyses; central blood presaure parameters; Other Names: Pulse wave velocity

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Rijnstate Hospital
• Investigators: Principal Investigator: Michel Reijnen, MD, PhD, Rijnstate

Publications and helpful links

General Publications

• Holewijn S, Vermeulen JJM, van Helvert M, van de Velde L, Reijnen MMPJ. Validation of Central Pressure Estimation in Patients with an Aortic Aneurysm Before and After Endovascular Repair. Cardiovasc Eng Technol. 2022 Apr;13(2):265-278. doi: 10.1007/s13239-021-00574-3. Epub 2021 Sep 28.

Study record dates

Study Major Dates

• Study Start (ACTUAL): April 24, 2017
• Primary Completion (ACTUAL): August 5, 2019
• Study Completion (ACTUAL): December 31, 2019

Study Registration Dates

• First Submitted: March 5, 2018
• First Submitted That Met QC Criteria: March 12, 2018
• First Posted (ACTUAL): March 19, 2018

Study Record Updates

• Last Update Posted (ACTUAL): March 11, 2020
• Last Update Submitted That Met QC Criteria: March 10, 2020
• Last Verified: March 1, 2020

More Information

Terms related to this study

• Keywords: EVAR, central pressure, arterial stiffness, AAA, elective surgery
• Additional Relevant MeSH Terms: Cardiovascular Diseases; Vascular Diseases; Aortic Diseases; Aneurysm; Aortic Aneurysm; Aortic Aneurysm, Abdominal
• Other Study ID Numbers: 2016-0820; NL57153.091.16 (OTHER: CMO-Arnhem Nijmegen)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No