Brief Title
Relation betwEen Abdominal Aorta and Carotid Artery Responses to SymPathetic stimulatiON uSing duplEx Ultrasound
Official Title
Relation betwEen Abdominal Aorta and Carotid Artery Responses to SymPathetic stimulatiON uSing duplEx Ultrasound
Brief 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. 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 Type
Observational
Primary Outcome
CAR-test
Secondary Outcome
CAR-test
Condition
Abdominal Aortic Aneurysm
Intervention
Carotid artery reactivity test (CAR-test)
Study Arms / Comparison Groups
1. Young healthy group
Description: 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
Publications
* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.
Recruitment Information
Recruitment Status
Diagnostic Test
Estimated Enrollment
60
Start Date
October 1, 2019
Completion Date
September 1, 2021
Primary Completion Date
September 1, 2020
Eligibility Criteria
Inclusion Criteria:
- 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;
Exclusion Criteria:
- 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;
- 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
Gender
All
Ages
N/A - N/A
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Contacts
Michel Reijnen, MD, Prof, 0880057282, [email protected]
Location Countries
Netherlands
Location Countries
Netherlands
Administrative Informations
NCT ID
NCT04035252
Organization ID
RESPONSE study
Responsible Party
Sponsor
Study Sponsor
Rijnstate Hospital
Collaborators
Radboud University
Study Sponsor
Michel Reijnen, MD, Prof, Principal Investigator, Rijnstate Hospital
Verification Date
February 2020