Infrarenal Abdominal Aortic AneurysmABCNCT03469388
Arterial Stiffness, Blood Pressure and Cardiac Output Study
A study testing Pulse wave analyses; central blood presaure parameters in people with Infrarenal Abdominal Aortic Aneurysm, run by Rijnstate Hospital at 1 site in Netherlands.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Infrarenal Abdominal Aortic Aneurysm
- What is being tested?
- Pulse wave analyses; central blood presaure parameters
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteNetherlands
- Study dates
- 24 Apr 2017to 31 Dec 2019
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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;
Trial locations and contacts
1 site in 1 country.
About this study
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
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.
- Conditions
- Infrarenal Abdominal Aortic Aneurysm
- Being tested
- Pulse wave analyses; central blood presaure parameters
- Keywords
- EVAR, central pressure, arterial stiffness, AAA, elective surgery
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Pulse wave analyses; central blood presaure parametersDiagnostic test
Also called Pulse wave velocity
Pulse wave analyses; central blood presaure parameters
| Study group | Role | What they receive |
|---|---|---|
| elective EVAR patients | Experimental | Elective EVAR patients will be included in one arm only Receives: Diagnostic Test: Pulse wave analyses; central blood presaure parameters |
What is being measured
The primary outcome is the main question the study is designed to answer.
central blood pressure
comparison of invasively recorded and non-invsively estimated central blood pressure
Measured: one week
Secondary outcomes (3)
changes in arterial stiffness pre- and post EVAR
changes in arterial stiffness pre- and post EVAR
Measured: 1 year
influence of thrombus on arterial stiffness
influence of thrombus on arterial stiffness
Measured: 1 year
changes in arterial stiffness over time
changes in arterial stiffness over time
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Mar 2018
- Study start24 Apr 2017
- Primary completion5 Aug 2019
- Study completion31 Dec 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Infrarenal Abdominal Aortic AneurysmStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- prospective,multidisciplinary single center study
- Masking
- None (open label)
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- Rijnstate Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Michel Reijnen, Rijnstate Hospital
- Investigators
- Michel Reijnen, MD, PhD, Principal investigator, Rijnstate
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03469388
- Sponsor's protocol ID
- 2016-0820
- Other IDs
- NL57153.091.16
- Acronym
- ABC
- Status last verified
- Mar 2020
- First submitted
- 5 Mar 2018
- Last updated
- 11 Mar 2020
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
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
Study at a glance
From the registry record, last updated by the sponsor on 11 Mar 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT03469388
- Acronym / sponsor ID
- ABC / 2016-0820
- Conditions
- Infrarenal Abdominal Aortic Aneurysm
- Keywords
- EVAR, central pressure, arterial stiffness, AAA, elective surgery
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- Rijnstate HospitalUniversity, hospital or other
- Study start
- 24 Apr 2017 (actual)
- Primary completion
- 5 Aug 2019 (actual)
- Study completion
- 31 Dec 2019 (actual)
- First posted
- 19 Mar 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
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 design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- prospective,multidisciplinary single center study
| Arm | Type | Receives |
|---|---|---|
| elective EVAR patients | Experimental | Diagnostic Test: Pulse wave analyses; central blood presaure parametersElective EVAR patients will be included in one arm only |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (6 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Pulse wave analyses; central blood presaure parametersAlso: Pulse wave velocityPulse wave analyses; central blood presaure parameters | Diagnostic test | elective EVAR patients |
Primary outcome
central blood pressure
Time frame: one week
comparison of invasively recorded and non-invsively estimated central blood pressure
3 secondary outcomes
changes in arterial stiffness pre- and post EVAR
Time frame: 1 year
influence of thrombus on arterial stiffness
Time frame: 1 year
changes in arterial stiffness over time
Time frame: 1 year
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Mar 2020.
- Derived from this study: PubMed 34585343Holewijn 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.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Michel Reijnen, MD, PhD principal investigator
Rijnstate
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Pulse wave analyses; central blood presaure parameters in people with Infrarenal Abdominal Aortic Aneurysm, run by Rijnstate Hospital at 1 site in Netherlands.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 11 Mar 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Netherlands. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
central blood pressure (time frame: one week). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03469388, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Mar 2020.