Abdominal Aortic AneurysmNCT03989011
Tonometry and Duplex Ultrasound to Predict AAA Progression and CV Events in Aneurysm Patients (1-2-3 Trial)
An observational study of Abdominal Aortic Aneurysm and Cardiovascular Events, run by Rijnstate Hospital at 3 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, highlighting the need to explore the potential of novel techniques. Read more about this study
- Who is it for?
- Any age
- 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
- 167 participants
- Where
- 3 sitesNetherlands
- Study dates
- 1 Jul 2019to 1 Dec 2023
- Phase
- Observational
- 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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: Patients under surveillance for an AAA, who are currently under threshold for repair (i.e. AAA diameter 40-50 mm men and 35-44 mm for women), 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 abdominal aortic aneurysm (AAA), who is still under surveillance;
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; this questionnaire can be found in Appendix 3);
- Presence of Raynaud's phenomenon, 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
3 sites in 1 country.
Netherlands3 sites
Rijnstate Hospital
Arnhem
Radboudumc
Nijmegen, Gelderland, 6525GA
Canisius Wilhelmina Ziekenhuis
Nijmegen, Gelderland, 6532SZ
About this study
Official title: Tonometry (1) and Duplex Ultrasound (2) to Predict Abdominal Aorta Aneurysm (3) Progression and Cardiovascular Events in Aneurysm Patients
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, highlighting the need to explore the potential of novel techniques. Both progression of AAA and CV events are strongly linked to vascular health. In 2013, the SMART risk score is 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 recently 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 in comparison to the SMART risk score for the development of cardiovascular events in patients with an abdominal aortic aneurysm who have not yet reached the treatment threshold. This could aid clinical decision making in the need for (surgical) intervention, but also alter (drug) treatment to reduce risk of cardiovascular events. Secondary objectives are to investigate the predictive capacity of the CAR-test for progression of the abdominal aortic aneurysm, and to evaluate QoL scores in patients under surveillance for AAA. The aim is to provide insight if these scores can help clinical decision making.
Read the detailed description
The investigators will include 167 patients under surveillance for AAA who are all currently under the threshold for repair (i.e. AAA diameter 40-50 mm for men and 35-45 mm for women). Participants will be recruited from all collaborating hospitals (Radboudumc, Rijnstate, CWZ) after providing written informed consent. Additionally, 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.
In this observational, prospective study, a total of 167 patients under surveillance for an AAA, who are currently under threshold for repair (i.e. AAA diameter 40-50 mm for men and 35-44 mm for women), 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), the investigators will perform the CAR-test (10-min) and non-invasive arterial stiffness measures (PWA and PWV with the SphygmoCor device (10-min) one time as baseline. Furthermore, the investigators will ask patients to complete a questionnaire about the quality of their life (Appendix 1). A second questionnaire tries to clarify the disease experience of the patients and can be found in Appendix 2. Both questionnaires will be asked to be completed at the start and the end of the study. 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 AAA progression (in mm/year) and 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 celsius) 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 (SEVR, 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, and peripheral vascular disease
Measured: 2 year follow-up
Secondary outcomes (18)
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
SphygmoCor parameters
Peripheral pressure measurements (PWA)
Measured: Baseline
SphygmoCor parameters
central pressure measurements (derived using a transfer function, PWA)
Measured: Baseline
SphygmoCor parameters
abdominal pressure measurements (derived using a transfer function, PWA)
Measured: Baseline
SphygmoCor parameters - cardiac output parameter
SEVR
Measured: Baseline
SphygmoCor parameters - cardiac output parameter
ED
Measured: Baseline
SphygmoCor parameters
PWV
Measured: Baseline
CAR-test results
Percentage of vasodilation/vasoconstriction to the CAR test at the common carotid artery at baseline
Measured: Baseline
CAR-test results
magnitude of the blood flow and perfusion response
Measured: Baseline
CAR-test results
timing of the blood flow and perfusion response
Measured: Baseline
CAR-test results
blood pressure responses
Measured: Baseline
CAR-test results
heart rate responses
Measured: Baseline
AAA progression
AAA diameter progression in mm/year
Measured: 2 year follow up
Aorta repair
If the patient underwent aorta repair
Measured: Within 2 year follow-up
AAA rupture
If the AAA ruptured
Measured: Within 2 year follow up
Score EQ-5D questionnaire
Patient reported outcomes measured by the general health questionnaire
Measured: At baseline and after 2 years
Score IPQ-K questionnaire
Patient reported outcomes measured by the disease perception questionnaire
Measured: At baseline and after 2 years
Clinical success
Incidence of serious adverse events
Measured: 2 year follow up
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Jun 2019
- Study start1 Jul 2019
- Primary completion1 May 2023
- Study completion1 Dec 2023
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
- 167 participants (actual)
Sponsor and investigators
- Lead sponsor
- Rijnstate Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Radboud University Medical Center, Canisius-Wilhelmina Hospital
- Responsible party
- Sponsor
- Investigators
- Michel Rijnen, MD, prof, Principal investigator, Rijnstate Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03989011
- Sponsor's protocol ID
- NL68953.091.19
- Status last verified
- Apr 2024
- First submitted
- 29 May 2019
- Last updated
- 11 Apr 2024
- 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 11 Apr 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Tonometry (1) and Duplex Ultrasound (2) to Predict Abdominal Aorta Aneurysm (3) Progression and Cardiovascular Events in Aneurysm Patients
- ClinicalTrials.gov ID
- NCT03989011
- Acronym / sponsor ID
- NL68953.091.19
- Conditions
- Abdominal Aortic Aneurysm, Cardiovascular Events
- Keywords
- Functional response, Abdominal Aortic Aneurysm, Cardiovascular events
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 167 participants (actual)
- Lead sponsor
- Rijnstate HospitalUniversity, hospital or other
- Collaborators
- Radboud University Medical Center, Canisius-Wilhelmina Hospital
- Study start
- 1 Jul 2019 (actual)
- Primary completion
- 1 May 2023 (actual)
- Study completion
- 1 Dec 2023 (actual)
- First posted
- 18 Jun 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, highlighting the need to explore the potential of novel techniques. Both progression of AAA and CV events are strongly linked to vascular health. In 2013, the SMART risk score is 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 recently 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 in comparison to the SMART risk score for the development of cardiovascular events in patients with an abdominal aortic aneurysm who have not yet reached the treatment threshold. This could aid clinical decision making in the need for (surgical) intervention, but also alter (drug) treatment to reduce risk of cardiovascular events. Secondary objectives are to investigate the predictive capacity of the CAR-test for progression of the abdominal aortic aneurysm, and to evaluate QoL scores in patients under surveillance for AAA. The aim is to provide insight if these scores can help clinical decision making.
Detailed description
The investigators will include 167 patients under surveillance for AAA who are all currently under the threshold for repair (i.e. AAA diameter 40-50 mm for men and 35-45 mm for women). Participants will be recruited from all collaborating hospitals (Radboudumc, Rijnstate, CWZ) after providing written informed consent. Additionally, 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.
In this observational, prospective study, a total of 167 patients under surveillance for an AAA, who are currently under threshold for repair (i.e. AAA diameter 40-50 mm for men and 35-44 mm for women), 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), the investigators will perform the CAR-test (10-min) and non-invasive arterial stiffness measures (PWA and PWV with the SphygmoCor device (10-min) one time as baseline. Furthermore, the investigators will ask patients to complete a questionnaire about the quality of their life (Appendix 1). A second questionnaire tries to clarify the disease experience of the patients and can be found in Appendix 2. Both questionnaires will be asked to be completed at the start and the end of the study. 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 AAA progression (in mm/year) and 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
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Patients under surveillance for an AAA, who are currently under threshold for repair (i.e. AAA diameter 40-50 mm men and 35-44 mm for women), 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 abdominal aortic aneurysm (AAA), who is still under surveillance;
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; this questionnaire can be found in Appendix 3);
- Presence of Raynaud's phenomenon, 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 celsius) 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 (SEVR, 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, and peripheral vascular disease
18 secondary outcomes
SMART risk score
Time frame: Baseline
SphygmoCor parameters
Time frame: Baseline
SphygmoCor parameters
Time frame: Baseline
SphygmoCor parameters
Time frame: Baseline
SphygmoCor parameters - cardiac output parameter
Time frame: Baseline
SphygmoCor parameters - cardiac output parameter
Time frame: Baseline
SphygmoCor parameters
Time frame: Baseline
CAR-test results
Time frame: Baseline
CAR-test results
Time frame: Baseline
CAR-test results
Time frame: Baseline
CAR-test results
Time frame: Baseline
CAR-test results
Time frame: Baseline
AAA progression
Time frame: 2 year follow up
Aorta repair
Time frame: Within 2 year follow-up
AAA rupture
Time frame: Within 2 year follow up
Score EQ-5D questionnaire
Time frame: At baseline and after 2 years
Score IPQ-K questionnaire
Time frame: At baseline and after 2 years
Clinical success
Time frame: 2 year follow up
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 Apr 2024.
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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 Rijnen, MD, prof principal investigator
Rijnstate Hospital
3 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 3 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: finished, as of the sponsor's last update on 11 Apr 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 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?
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?
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 11 Apr 2024.