Abdominal Aortic AneurysmRESPONSENCT04035252
Relation betwEen Abdominal Aorta and Carotid Artery Responses to SymPathetic stimulatiON uSing duplEx Ultrasound
An observational study of Abdominal Aortic Aneurysm, run by Rijnstate Hospital at 2 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. Read more about this study
- Who is it for?
- Any ageHealthy volunteers can take part
- Conditions the study is for
- Abdominal Aortic Aneurysm
- What is being tested?
- Carotid artery reactivity test (CAR-test)
- How many people
- 60 participants
- Where
- 2 sitesNetherlands
- Study dates
- 1 Oct 2019to 5 Oct 2020
- 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
- Healthy volunteers accepted
- Child, Adult, Older adult
Study population: 1. twenty healthy, young (18-40 years) subjects, 2. twenty older subjects (>60 years) with a small, stable abdominal aortic aneurysm (i.e. AAA diameter of 30-50 mm), and 3. twenty healthy, age-/sex matched with group 2. We aim to include an equal number of male and females in both groups.
Who may be able to join
- Young healthy group: Male or female between the age of 18 and 40 years old;
- Older healthy group: Male or female, which are age-/sex-matched with the AAA patients group;
- AAA patients group: Male or female with an abdominal aortic aneurysm who is still under surveillance, with a diameter between 3.0 and 5.0 cm and at least 18 years old. These patients may participate in the 1-2-3 Trial, which is a similar approved investigation by CMO region Arnhem-Nijmegen with registration number 2019-5216.
- Informed consent form understood and signed;
Who cannot join
- Psychiatric or other conditions that may interfere with the study;
- Participating in another clinical study, interfering on outcomes;
- With regard to the necessary quality of the ultrasound images, BMI ≥ 30 kg/m2;
- Increased risk for coronary spasms (score Rose-questionnaire ≥2; this questionnaire can be found in the Appendix);
- Known carotid artery disease
- 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;
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- Recent (<3 months) presence of angina pectoris, myocardial infarction, cerebral infarction, and/or heart failure, or PAD treatment.
- Healthy groups:
- Systolic blood pressure >140 and/or diastolic blood pressure >90
- Cardiovascular history
- Antihypertensive medication
Trial locations and contacts
2 sites in 1 country.
Netherlands2 sites
Rijnstate Hospital
Arnhem, Gelderland
Radboudumc
Nijmegen, Gelderland, 6525GA
About this study
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. Recent studies suggest that the endothelial function of the abdominal aorta might have a correlation with the disease development. A novel, easy to perform, non-invasive test can assess central artery endothelial function (i.e. the carotid artery reactivity (CAR)). The CAR test is based on the cold pressure test (CPT), which induces sympathetic stimulation by placing one hand in cold water. Using duplex ultrasound, central artery blood flow and diameter responses can be examined.
Previous work has demonstrated that the CPT is associated with an increase in abdominal aortic diameter, whilst others found that the carotid and coronary artery diameter also shows dilation. Interestingly, a previous study found a strong correlation between carotid and coronary artery diameter responses to the CPT, whilst these artery responses show independent prognostic value for future cardiovascular events in patients with peripheral arterial disease. Possibly, similarity may be present in central artery reactivity to the CPT. To date, no study examined whether carotid and aorta responses are in agreement during the CPT. Given the potential importance of central artery vasoreactivity for AAA, the CAR-test may have potential in this group, especially given the relative simplicity of measuring the carotid artery.
The aim of this explorative study is to investigate the correlation between the magnitude of the abdominal aorta and the carotid artery diameter and blood flow responses during the sympathetic stimulation (using the cold pressor test) between healthy young, healthy older and individuals with AAA.
Read the detailed description
The present study is an explorative, observational study, which will include in total 60 participants divided over 3 groups; healthy young adults, healthy older adults and patients with a stable abdominal aortic aneurysm (i.e. 30-50 mm), who are currently under threshold for repair. When participants meet the criteria, they will be informed about the study and they will be asked for their written informed consent, when they are willing to participate. Every participant only need to visit one time, which takes approximately 30 minutes. Participant characteristics will be registered, including traditional risk factors and CV history. Subsequently, the investigators will perform the CAR-test, which takes approximately 15 minutes. Prior to the CAR-test, participants should follow some instructions with regard to food and fluid intake according to a physiological guideline, which can influence this test.
- Conditions
- Abdominal Aortic Aneurysm
- Being tested
- Carotid artery reactivity test (CAR-test)
- Keywords
- Functional response, Abdominal aortic aneurysm, Carotid artery
- 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. During this test as well the carotid artery as the abdominal aorta will be visualized using ultrasound.
| Study group | Role | What they receive |
|---|---|---|
| 1. Young healthy group | Male or female between the age of 18 and 40 years old. No presence of systolic blood pressure >140 and/or diastolic blood pressure >90, cardiovascular history or antihypertensive medication Receives: Diagnostic Test: Carotid artery reactivity test (CAR-test) | |
| 2. Patients with an AAA | Individuals (>60 years) with a small, stable, abdominal aortic aneurysm (i.e. AAA diameter of 30-50 mm) Receives: Diagnostic Test: Carotid artery reactivity test (CAR-test) | |
| 3. Healthy older group | Healthy age- and sex- matched with group 2 with no presence of systolic blood pressure >140 and/or diastolic blood pressure >90, cardiovascular history or antihypertensive medication Receives: Diagnostic Test: Carotid artery reactivity test (CAR-test) |
What is being measured
The primary outcome is the main question the study is designed to answer.
CAR-test
Percentage of vasodilation/vasoconstriction to the CAR test at the common carotid artery
Measured: Baseline
CAR-test
Percentage of vasodilation/vasoconstriction to the CAR test at the abdominal aorta
Measured: Baseline
Secondary outcomes (7)
CAR-test
Magnitude of the blood flow and perfusion response of the carotid artery
Measured: Baseline
CAR-test
Timing of the blood flow and perfusion response of the carotid artery
Measured: Baseline
CAR-test
Magnitude of the blood flow and perfusion response of the abdominal aorta
Measured: Baseline
CAR-test
Timing of the blood flow and perfusion response of the abdominal aorta
Measured: Baseline
CAR-test
Blood pressure response
Measured: Baseline
CAR-test
Heart rate response
Measured: Baseline
Age
Age
Measured: Baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Jul 2019
- Study start1 Oct 2019
- Primary completion1 Aug 2020
- Study completion5 Oct 2020
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
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- Rijnstate Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Radboud University Medical Center
- Responsible party
- Sponsor
- Investigators
- Michel Reijnen, MD, Prof, Principal investigator, Rijnstate Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04035252
- Sponsor's protocol ID
- RESPONSE study
- Acronym
- RESPONSE
- Status last verified
- Oct 2020
- First submitted
- 25 Jul 2019
- Last updated
- 12 Oct 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 12 Oct 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Relation betwEen Abdominal Aorta and Carotid Artery Responses to SymPathetic stimulatiON uSing duplEx Ultrasound
- ClinicalTrials.gov ID
- NCT04035252
- Acronym / sponsor ID
- RESPONSE / RESPONSE study
- Conditions
- Abdominal Aortic Aneurysm
- Keywords
- Functional response, Abdominal aortic aneurysm, Carotid artery
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Rijnstate HospitalUniversity, hospital or other
- Collaborators
- Radboud University Medical Center
- Study start
- 1 Oct 2019 (actual)
- Primary completion
- 1 Aug 2020 (actual)
- Study completion
- 5 Oct 2020 (actual)
- First posted
- 29 Jul 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. Recent studies suggest that the endothelial function of the abdominal aorta might have a correlation with the disease development. A novel, easy to perform, non-invasive test can assess central artery endothelial function (i.e. the carotid artery reactivity (CAR)). The CAR test is based on the cold pressure test (CPT), which induces sympathetic stimulation by placing one hand in cold water. Using duplex ultrasound, central artery blood flow and diameter responses can be examined.
Previous work has demonstrated that the CPT is associated with an increase in abdominal aortic diameter, whilst others found that the carotid and coronary artery diameter also shows dilation. Interestingly, a previous study found a strong correlation between carotid and coronary artery diameter responses to the CPT, whilst these artery responses show independent prognostic value for future cardiovascular events in patients with peripheral arterial disease. Possibly, similarity may be present in central artery reactivity to the CPT. To date, no study examined whether carotid and aorta responses are in agreement during the CPT. Given the potential importance of central artery vasoreactivity for AAA, the CAR-test may have potential in this group, especially given the relative simplicity of measuring the carotid artery.
The aim of this explorative study is to investigate the correlation between the magnitude of the abdominal aorta and the carotid artery diameter and blood flow responses during the sympathetic stimulation (using the cold pressor test) between healthy young, healthy older and individuals with AAA.
Detailed description
The present study is an explorative, observational study, which will include in total 60 participants divided over 3 groups; healthy young adults, healthy older adults and patients with a stable abdominal aortic aneurysm (i.e. 30-50 mm), who are currently under threshold for repair. When participants meet the criteria, they will be informed about the study and they will be asked for their written informed consent, when they are willing to participate. Every participant only need to visit one time, which takes approximately 30 minutes. Participant characteristics will be registered, including traditional risk factors and CV history. Subsequently, the investigators will perform the CAR-test, which takes approximately 15 minutes. Prior to the CAR-test, participants should follow some instructions with regard to food and fluid intake according to a physiological guideline, which can influence this test.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| 1. Young healthy group | – | Diagnostic Test: Carotid artery reactivity test (CAR-test)Male or female between the age of 18 and 40 years old. No presence of systolic blood pressure >140 and/or diastolic blood pressure >90, cardiovascular history or antihypertensive medication |
| 2. Patients with an AAA | – | Diagnostic Test: Carotid artery reactivity test (CAR-test)Individuals (>60 years) with a small, stable, abdominal aortic aneurysm (i.e. AAA diameter of 30-50 mm) |
| 3. Healthy older group | – | Diagnostic Test: Carotid artery reactivity test (CAR-test)Healthy age- and sex- matched with group 2 with no presence of systolic blood pressure >140 and/or diastolic blood pressure >90, cardiovascular history or antihypertensive medication |
Who may qualify
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
- Study population
- 1. twenty healthy, young (18-40 years) subjects, 2. twenty older subjects (>60 years) with a small, stable abdominal aortic aneurysm (i.e. AAA diameter of 30-50 mm), and 3. twenty healthy, age-/sex matched with group 2. We aim to include an equal number of male and females in both groups.
Key inclusion criteria (4 listed)
- Young healthy group: Male or female between the age of 18 and 40 years old;
- Older healthy group: Male or female, which are age-/sex-matched with the AAA patients group;
- AAA patients group: Male or female with an abdominal aortic aneurysm who is still under surveillance, with a diameter between 3.0 and 5.0 cm and at least 18 years old. These patients may participate in the 1-2-3 Trial, which is a similar approved investigation by CMO region Arnhem-Nijmegen with registration number 2019-5216.
- Informed consent form understood and signed;
Key exclusion criteria (11 listed)
- Psychiatric or other conditions that may interfere with the study;
- Participating in another clinical study, interfering on outcomes;
- With regard to the necessary quality of the ultrasound images, BMI ≥ 30 kg/m2;
- Increased risk for coronary spasms (score Rose-questionnaire ≥2; this questionnaire can be found in the Appendix);
- Known carotid artery disease
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. During this test as well the carotid artery as the abdominal aorta will be visualized using ultrasound. | Diagnostic test | 1. Young healthy group, 2. Patients with an AAA, 3. Healthy older group |
Primary outcome
CAR-test
Time frame: Baseline
Percentage of vasodilation/vasoconstriction to the CAR test at the common carotid artery
CAR-test
Time frame: Baseline
Percentage of vasodilation/vasoconstriction to the CAR test at the abdominal aorta
7 secondary outcomes
CAR-test
Time frame: Baseline
CAR-test
Time frame: Baseline
CAR-test
Time frame: Baseline
CAR-test
Time frame: Baseline
CAR-test
Time frame: Baseline
CAR-test
Time frame: Baseline
Age
Time frame: Baseline
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 12 Oct 2020.
- 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, Prof principal investigator
Rijnstate Hospital
2 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, run by Rijnstate Hospital at 2 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 4 inclusion and 11 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 12 Oct 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 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?
CAR-test (time frame: Baseline). The study lists 2 primary outcomes in all. 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 12 Oct 2020.