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CompletedNCT03469388ABCUpdated Mar 11, 2020

Arterial Stiffness, Blood Pressure and Cardiac Output Study

An interventional study of Pulse wave analyses; central blood presaure parameters in Infrarenal Abdominal Aortic Aneurysm, sponsored by Rijnstate Hospital. Completed at 1 site in Netherlands. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2020-03-11.

Sponsored by Rijnstate Hospital · Not applicable, Interventional, and Diagnostic

Phase
Not applicable
Study type
Interventional
Enrollment
20
Allocation
Not applicable
Ages
18 Years and older
Sex
All
01

Study 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.

Read the 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.

02

Conditions studied

  • Infrarenal Abdominal Aortic Aneurysm

Keywords

  • EVAR, central pressure, arterial stiffness, AAA, elective surgery
03

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

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

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;
04

Study design

Phase
Not applicable
Primary purpose
Diagnostic
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
20 participants (actual)

Study arms

  • Experimental
    elective EVAR patients

    Elective EVAR patients will be included in one arm only

    Diagnostic Test: Pulse wave analyses; central blood presaure parameters

Interventions

  • Diagnostic testPulse wave analyses; central blood presaure parameters

    Pulse wave analyses; central blood presaure parameters

    Also known as: Pulse wave velocity

05

What researchers measure

Primary outcomes

  1. central blood pressure

    comparison of invasively recorded and non-invsively estimated central blood pressure

    Time frame: one week

Secondary outcomes

  1. changes in arterial stiffness pre- and post EVAR

    changes in arterial stiffness pre- and post EVAR

    Time frame: 1 year

  2. influence of thrombus on arterial stiffness

    influence of thrombus on arterial stiffness

    Time frame: 1 year

  3. changes in arterial stiffness over time

    changes in arterial stiffness over time

    Time frame: 1 year

06

Study locations

1 site
  • Rijnstate Hospital
    Arnhem, Gelderland 6800 TA, Netherlands
07

References and documents

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. PubMed 34585343 ↗

Individual participant data

Plan to share: Undecided

08

Registry details

Key details

Study ID
NCT03469388
Lead sponsor
Rijnstate Hospital
Responsible party
Michel Reijnen (MD, PhD, Rijnstate Hospital) — Principal investigator
First posted
Mar 19, 2018
Start date
Apr 24, 2017
Primary completion
Aug 5, 2019
Completion
Dec 31, 2019
Last update
Mar 11, 2020

Study contacts

Michel Reijnen, MD, PhD
principal investigator · Rijnstate

Oversight

Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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