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…
ID
Source
Brief title
Condition
- Aneurysms and artery dissections
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
The main study endpoint is the results of the CPT of the abdominal aorta and
the carotid artery for each participant; this can be either a vasodilation or
vasoconstriction in response to the sympathetic stimulus.
Secondary outcome
Secondary parameters include:
- Other CPT results of the abdominal aorta and the carotid artery
o Magnitude and timing of the blood flow and perfusion response
o Blood pressure and heart rate response
- Age
Background 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.
Study objective
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.
Study design
Explorative, observational study.
Study burden and risks
The test will take approximately 20 minutes, is non-invasive and will provide
more knowledge about the correlation between the vasoreactivity of the carotid
artery and the abdominal aorta. Upon confirming a correlation, the CAR-test may
be further explored as a novel, non-invasive, simple technology to predict
AAA-progression and/or improve decision-making pertaining to when and whether
to treat the aneurysm in AAA patients. The used technique have no risk for the
participants. Whilst the CAR-test may cause mild discomfort, which is quickly
alleviated after the 3 minutes frame and does not result in any lasting effect.
Wagnerlaan 55
Arnhem 6815AD
NL
Wagnerlaan 55
Arnhem 6815AD
NL
Listed location countries
Age
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);
- 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:
o Systolic blood pressure >140 mmHg and/or diastolic blood pressure >90 mmHg
o Cardiovascular history
o Antihypertensive medication
Design
Recruitment
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| CCMO | NL70352.091.19 |