Abdominal Aortic AneurysmOne-Two-TreatNCT04183426
Tonometry(1) and Duplex Ultrasound(2) to Predict CV Events in to be Treated Patients With an AAA
An observational study of Abdominal Aortic Aneurysm and Cardiovascular Events, run by Rijnstate Hospital at 7 sites in Netherlands.
Trial summary
Abdominal aortic aneurysm (AAA) is a common vascular disease and associated with risk of rupture, but also with a high cardiovascular (CV) event rate. A key difficulty in AAA is predicting these life-threatening complications, which are strongly linked to vascular health. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Abdominal Aortic Aneurysm, Cardiovascular Events
- What is being tested?
- Carotid Artery Reactivity test (CAR test) and Arterial Stiffness
- How many people
- 194 participants
- Where
- 7 sitesNetherlands
- Study dates
- 12 Jun 2020to Jun 2027
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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
Study population: Patients with an AAA who will be scheduled for repair, will be included. AAA patients will be recruited from all collaborating hospitals (Radboudumc, Rijnstate, CWZ), who provide written informed consent. Additionally, also AAA-patients under surveillance of general practitioners are eligible (and will be contacted through the hospital-links), since the nature of the tests allow for performing all tests at the general practitioners' office.
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;
- Has an infrarenal or juxtarenal abdominal aortic aneurysm (AAA), scheduled for elective repair (i.e open repair, EVAR, FEVAR and CHEVAR) according to standard practice;
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;
- Increased risk for coronary spasms (score Rose-questionnaire ≥2;
- Presence of Raynaud's phenomenon, Marfan syndrome, chronic pain syndrome at upper extremity(s), presence of an AV fistula or shunt, open wounds to the upper extremity(s), and/or scleroderma associated with placing the hand in ice water;
- Recent (<3 months) presence of angina pectoris, myocardial infarction, cerebral infarction, and/or heart failure, or PAD treatment.
Trial locations and contacts
7 sites in 1 country. Contact the study team or a site near you to ask about taking part.
7 sites in 1 country
Netherlands7 sites, 7 recruiting
- Recruiting
Gelre Hospitals
Apeldoorn
Hessel Buscher, h.buscher@gelre.nl
Franka de Valk, Franka.de.Valk@gelre.nl
- Recruiting
Deventer Hospital
Deventer
Lieuwe van der Hem, L.vanderHem@dz.nl
- Recruiting
Ziekenhuis Gelderse Vallei
Ede
Hans Sybrandy, SybrandyH@zgv.nl
- Recruiting
Medisch Spectrum Twente
Enschede
Theo Menting, Theo.Menting@mst.nl
Anja Stam, Researchbureau.Heelkunde@mst.nl
- Recruiting
Radboudumc
Nijmegen, Gelderland, 6525GA
Dick Thijssen, Prof, +31 (0)24-361 42 09, Dick.Thijssen@radboudumc.nl
Jenske Vermeulen, MSc., +31 (0)24-361 42 09, Jenske.Vermeulen@radboudumc.nl
- Recruiting
Canisius Wilhelmina Ziekenhuis
Nijmegen, Gelderland, 6532SZ
Bianca Bendermacher, MD, B.Bendermacher@cwz.nl
Manon Bindels, M.Bindels@cwz.nl
- Recruiting
Maxima Medical Center
Veldhoven
Maarten Loos, Maarten.Loos@mmc.nl
Margot Heijmans, Margot.Heijmans@mmc.nl
About this study
Official title: Tonometry(1) and Duplex Ultrasound(2) to Predict Cardiovascular Events in to be Treated Patients With an Abdominal Aortic Aneurysm (One-Two-Treat Trial)
Abdominal aortic aneurysm (AAA) is a common vascular disease and associated with risk of rupture, but also with a high cardiovascular (CV) event rate. A key difficulty in AAA is predicting these life-threatening complications, which are strongly linked to vascular health. In 2013, the SMART risk score was developed to calculate the risk of the patients for recurrent vascular events based on clinical characteristics. Recently, a novel, easy to perform, non-invasive test of endothelial function (the carotid artery reactivity (CAR) test), reflecting target organ damage, has been introduced. The CAR is a simple, quick (5-min), non-invasive test that uses ultrasound to examine the carotid artery in response to sympathetic stimulation by placing one hand in cold water. This test shows strong agreement with both coronary and aortic responses to sympathetic stimulation and predicted CV-events in patients with peripheral arterial disease.
The aim of this prospective 2-year follow-up study is to investigate the predictive capacity of the CAR-test for development of CV-events after elective AAA repair in comparison to the SMART risk score. Secondary objectives are to investigate the predictive capacity of arterial stiffness measurements and the post-operative CAR-test for development of CV-events and to evaluate health status scores to provide insight if these scores can support clinical decision making.
Read the detailed description
The investigators will include 194 patients with an AAA who will be scheduled for repair. Participants will be recruited from all collaborating hospitals (currently Radboudumc, Rijnstate, CWZ) after providing written informed consent.
In this observational, prospective study, a total of 194 patients who are going to be treated for their AAA will be included. Baseline patient characteristics will be registered, including traditional risk factors and CV-history. In addition to regular care of measuring AAA diameter progression (in mm/year), we will perform the CAR-test (10-min) and non-invasive arterial stiffness measures (PWA and PWV) with the SphygmoCor device (10-min).
Furthermore, the investigators will ask patients to complete a questionnaire about the quality of their life. A second questionnaire tries to clarify the disease experience of the patients. Both questionnaires will be asked to be completed at the start, 6-8 weeks after repair, after one year and after two years of repair. Subsequently, the investigators will record major adverse cardiovascular events (MACE) according to the International Classification of Disease-10. Registration of MACE will be performed using hospital-records and following international guidelines. Across a 2-year follow-up, by means of regular follow-up appointments, the investigators will examine the ability of the CAR parameter and arterial stiffness parameters to predict CV-events.
- Conditions
- Abdominal Aortic Aneurysm, Cardiovascular Events
- Being tested
- Carotid Artery Reactivity test (CAR test), Arterial Stiffness
- Keywords
- Functional Response, Abdominal Aortic Aneurysm, Cardiovascular Events
- Medical subject headings
- Aortic Aneurysm, Abdominal
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Carotid Artery Reactivity test (CAR test)Diagnostic test
The CAR test will be applied to stimulate the sympathetic nervous system. This thermal stimulus is known to elevate blood pressure via sympathetic pathways, so it can be used to study the vascular response to sympathetic activation. The participant will submerge their left hand in a bucket of ice water (approximately 4 degrees celcius) for 3 minutes, which is reported to be sufficient to induce a maximal dilation in the common carotid artery. At baseline and every minute after the hand is submerged in ice water, the blood pressure will be measured to check whether a sympathetic stimulation is achieved.
Arterial StiffnessDiagnostic test
The SphygmoCor device will be used to non-invasively measure arterial stiffness parameters using applanation tonometry. For Pulse Wave Analyses (PWA), the radial waveform will be recorded. Approximately 10 waveforms are averaged, resulting in several non-invasive parameters:
- Peripheral pressure parameters
- Central and abdominal aneurysm pressure parameters (derived using a transfer function)
- Cardiac output parameters (sub-endocardial viability ratio (SEVR), Ejection Duration (ED))
Pulse wave velocity will be performed by recording the waveforms of the carotid and femoral artery sequentially. The travelled distance will be measured according to the current guidelines and entered in the program. The program will calculate the PWV based on 10 ECG triggered waveform of each artery.
What is being measured
The primary outcome is the main question the study is designed to answer.
Major Adverse Cardiovascular Events (MACE)
Incidence of MACE, including myocardial infarction, cerebral infarction, heart failure, rupture, and peripheral vascular disease
Measured: 2-year follow-up
Secondary outcomes (21)
SMART Risk score
Second Manifestations of ARTerial disease risk score is developed to determine the risk of recurrent vascular events based on clinical characteristics of the patients
Measured: Baseline
CAR-test results
Percentage of vasodilation/vasoconstriction to the CAR test at the common carotid artery at baseline
Measured: Baseline and 6-weeks after operation
CAR-test results
Magnitude of the blood flow and perfusion response
Measured: Baseline and 6-weeks after operation
CAR-test results
Timing of the blood flow and perfusion response
Measured: Baseline and 6-weeks after operation
CAR-test results
Blood pressure responses
Measured: Baseline and 6-weeks after operation
CAR-test results
Heart rate responses
Measured: Baseline and 6-weeks after operation
CAR-test results
Changes after treatment
Measured: Baseline and 6-weeks after operation
SphygmoCor parameters
Peripheral pressure measurements (PWA)
Measured: Baseline, 6-weeks, 1 year and 2 year after operation
SphygmoCor parameters
Central pressure measurements (derived using a transfer function, PWA)
Measured: Baseline, 6-weeks, 1 year and 2 year after operation
SphygmoCor parameters
Abdominal pressure measurements (derived using a transfer function, PWA)
Measured: Baseline, 6-weeks, 1 year and 2 year after operation
SphygmoCor parameters
SEVR
Measured: Baseline, 6-weeks, 1 year and 2 year after operation
SphygmoCor parameters
ED
Measured: Baseline, 6-weeks, 1 year and 2 year after operation
SphygmoCor parameters
PWV
Measured: Baseline, 6-weeks, 1 year and 2 year after operation
SphygmoCor parameters
Change in Peripheral pressure measurements (PWA) after treatment
Measured: Baseline and 6-weeks after operation
SphygmoCor parameters
Change in Central pressure measurements (derived using a transfer function, PWA) after treatment
Measured: Baseline and 6-weeks after operation
SphygmoCor parameters
Change in Abdominal pressure measurements (derived using a transfer function, PWA) after treatment
Measured: Baseline and 6-weeks after operation
SphygmoCor parameters
Change in SEVR after treatment
Measured: Baseline and 6-weeks after operation
SphygmoCor parameters
Change in ED after treatment
Measured: Baseline and 6-weeks after operation
SphygmoCor parameters
Change in PWV after treatment
Measured: Baseline and 6-weeks after operation
Score EQ-5D questionnaire
Patient reported outcomes measured by the general health questionnaire
Measured: Baseline, 6-weeks, 1 year and 2 year after operation
Score IPQ-K questionnaire
Patient reported outcomes measured by the disease perception questionnaire
Measured: Baseline, 6-weeks, 1 year and 2 year after operation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Dec 2019
- Study start12 Jun 2020
- Primary completionDec 2026 (estimated)
- Study completionJun 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 194 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Rijnstate Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Radboud University Medical Center, Canisius-Wilhelmina Hospital, Gelderse Vallei Hospital, Medisch Spectrum Twente, Deventer Ziekenhuis, Gelre Hospitals, Maxima Medical Center
- Responsible party
- Sponsor
- Investigators
- Michel Reijnen, MD, prof, Principal investigator, Rijnstate Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04183426
- Sponsor's protocol ID
- One-Two-Treat Trial
- Acronym
- One-Two-Treat
- Status last verified
- Mar 2025
- First submitted
- 19 Nov 2019
- Last updated
- 6 Mar 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Mar 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Tonometry(1) and Duplex Ultrasound(2) to Predict Cardiovascular Events in to be Treated Patients With an Abdominal Aortic Aneurysm (One-Two-Treat Trial)
- ClinicalTrials.gov ID
- NCT04183426
- Acronym / sponsor ID
- One-Two-Treat / One-Two-Treat Trial
- Conditions
- Abdominal Aortic Aneurysm, Cardiovascular Events
- Keywords
- Functional Response, Abdominal Aortic Aneurysm, Cardiovascular Events
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 194 participants (estimated)
- Lead sponsor
- Rijnstate HospitalUniversity, hospital or other
- Collaborators
- Radboud University Medical Center, Canisius-Wilhelmina Hospital, Gelderse Vallei Hospital, Medisch Spectrum Twente, Deventer Ziekenhuis, Gelre Hospitals, Maxima Medical Center
- Study start
- 12 Jun 2020 (actual)
- Primary completion
- Dec 2026 (estimated)
- Study completion
- Jun 2027 (estimated)
- First posted
- 3 Dec 2019 (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.
Abdominal aortic aneurysm (AAA) is a common vascular disease and associated with risk of rupture, but also with a high cardiovascular (CV) event rate. A key difficulty in AAA is predicting these life-threatening complications, which are strongly linked to vascular health. In 2013, the SMART risk score was developed to calculate the risk of the patients for recurrent vascular events based on clinical characteristics. Recently, a novel, easy to perform, non-invasive test of endothelial function (the carotid artery reactivity (CAR) test), reflecting target organ damage, has been introduced. The CAR is a simple, quick (5-min), non-invasive test that uses ultrasound to examine the carotid artery in response to sympathetic stimulation by placing one hand in cold water. This test shows strong agreement with both coronary and aortic responses to sympathetic stimulation and predicted CV-events in patients with peripheral arterial disease.
The aim of this prospective 2-year follow-up study is to investigate the predictive capacity of the CAR-test for development of CV-events after elective AAA repair in comparison to the SMART risk score. Secondary objectives are to investigate the predictive capacity of arterial stiffness measurements and the post-operative CAR-test for development of CV-events and to evaluate health status scores to provide insight if these scores can support clinical decision making.
Detailed description
The investigators will include 194 patients with an AAA who will be scheduled for repair. Participants will be recruited from all collaborating hospitals (currently Radboudumc, Rijnstate, CWZ) after providing written informed consent.
In this observational, prospective study, a total of 194 patients who are going to be treated for their AAA will be included. Baseline patient characteristics will be registered, including traditional risk factors and CV-history. In addition to regular care of measuring AAA diameter progression (in mm/year), we will perform the CAR-test (10-min) and non-invasive arterial stiffness measures (PWA and PWV) with the SphygmoCor device (10-min).
Furthermore, the investigators will ask patients to complete a questionnaire about the quality of their life. A second questionnaire tries to clarify the disease experience of the patients. Both questionnaires will be asked to be completed at the start, 6-8 weeks after repair, after one year and after two years of repair. Subsequently, the investigators will record major adverse cardiovascular events (MACE) according to the International Classification of Disease-10. Registration of MACE will be performed using hospital-records and following international guidelines. Across a 2-year follow-up, by means of regular follow-up appointments, the investigators will examine the ability of the CAR parameter and arterial stiffness parameters to predict CV-events.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients with an AAA who will be scheduled for repair, will be included. AAA patients will be recruited from all collaborating hospitals (Radboudumc, Rijnstate, CWZ), who provide written informed consent. Additionally, also AAA-patients under surveillance of general practitioners are eligible (and will be contacted through the hospital-links), since the nature of the tests allow for performing all tests at the general practitioners' office.
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;
- Has an infrarenal or juxtarenal abdominal aortic aneurysm (AAA), scheduled for elective repair (i.e open repair, EVAR, FEVAR and CHEVAR) according to standard practice;
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;
- Increased risk for coronary spasms (score Rose-questionnaire ≥2;
- Presence of Raynaud's phenomenon, Marfan syndrome, chronic pain syndrome at upper extremity(s), presence of an AV fistula or shunt, open wounds to the upper extremity(s), and/or scleroderma associated with placing the hand in ice water;
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 |
|---|---|---|
| Carotid Artery Reactivity test (CAR test)The CAR test will be applied to stimulate the sympathetic nervous system. This thermal stimulus is known to elevate blood pressure via sympathetic pathways, so it can be used to study the vascular response to sympathetic activation. The participant will submerge their left hand in a bucket of ice water (approximately 4 degrees celcius) for 3 minutes, which is reported to be sufficient to induce a maximal dilation in the common carotid artery. At baseline and every minute after the hand is submerged in ice water, the blood pressure will be measured to check whether a sympathetic stimulation is achieved. | Diagnostic test | – |
| Arterial StiffnessThe SphygmoCor device will be used to non-invasively measure arterial stiffness parameters using applanation tonometry. For Pulse Wave Analyses (PWA), the radial waveform will be recorded. Approximately 10 waveforms are averaged, resulting in several non-invasive parameters: * Peripheral pressure parameters * Central and abdominal aneurysm pressure parameters (derived using a transfer function) * Cardiac output parameters (sub-endocardial viability ratio (SEVR), Ejection Duration (ED)) Pulse wave velocity will be performed by recording the waveforms of the carotid and femoral artery sequentially. The travelled distance will be measured according to the current guidelines and entered in the program. The program will calculate the PWV based on 10 ECG triggered waveform of each artery. | Diagnostic test | – |
Primary outcome
Major Adverse Cardiovascular Events (MACE)
Time frame: 2-year follow-up
Incidence of MACE, including myocardial infarction, cerebral infarction, heart failure, rupture, and peripheral vascular disease
21 secondary outcomes
SMART Risk score
Time frame: Baseline
CAR-test results
Time frame: Baseline and 6-weeks after operation
CAR-test results
Time frame: Baseline and 6-weeks after operation
CAR-test results
Time frame: Baseline and 6-weeks after operation
CAR-test results
Time frame: Baseline and 6-weeks after operation
CAR-test results
Time frame: Baseline and 6-weeks after operation
CAR-test results
Time frame: Baseline and 6-weeks after operation
SphygmoCor parameters
Time frame: Baseline, 6-weeks, 1 year and 2 year after operation
SphygmoCor parameters
Time frame: Baseline, 6-weeks, 1 year and 2 year after operation
SphygmoCor parameters
Time frame: Baseline, 6-weeks, 1 year and 2 year after operation
SphygmoCor parameters
Time frame: Baseline, 6-weeks, 1 year and 2 year after operation
SphygmoCor parameters
Time frame: Baseline, 6-weeks, 1 year and 2 year after operation
SphygmoCor parameters
Time frame: Baseline, 6-weeks, 1 year and 2 year after operation
SphygmoCor parameters
Time frame: Baseline and 6-weeks after operation
SphygmoCor parameters
Time frame: Baseline and 6-weeks after operation
SphygmoCor parameters
Time frame: Baseline and 6-weeks after operation
SphygmoCor parameters
Time frame: Baseline and 6-weeks after operation
SphygmoCor parameters
Time frame: Baseline and 6-weeks after operation
SphygmoCor parameters
Time frame: Baseline and 6-weeks after operation
Score EQ-5D questionnaire
Time frame: Baseline, 6-weeks, 1 year and 2 year after operation
Score IPQ-K questionnaire
Time frame: Baseline, 6-weeks, 1 year and 2 year after operation
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Mar 2025.
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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.
Michel Reijnen, MD, prof principal investigator
Rijnstate Hospital
7 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Abdominal Aortic Aneurysm and Cardiovascular Events, run by Rijnstate Hospital at 7 sites 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: looking for participants now, as of the sponsor's last update on 6 Mar 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 7 sites 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Michel Reijnen, MD, prof (0880057282, MReijnen@rijnstate.nl), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Major Adverse Cardiovascular Events (MACE) (time frame: 2-year follow-up). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 6 Mar 2025.