Relation betwEen Abdominal Aorta and Carotid Artery Responses to SymPathetic stimulatiON uSing duplEx Ultrasound

Abdominal Aortic Aneurysm Clinical Trial

— RESPONSE  

Official title:

Relation betwEen Abdominal Aorta and Carotid Artery Responses to SymPathetic stimulatiON uSing duplEx Ultrasound

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04035252
• Other study ID #: RESPONSE study
• Status: Completed
• Start date: October 1, 2019
• Est. completion date: October 5, 2020

Study information

• Verified date: October 2020
• Source: Rijnstate Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical 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. 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 60
• Est. completion date: October 5, 2020
• Est. primary completion date: August 1, 2020
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: N/A and older

Eligibility

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

Related Conditions & MeSH terms

• Abdominal Aortic Aneurysm
• Aneurysm
• Aortic Aneurysm
• Aortic Aneurysm, Abdominal

Intervention

Diagnostic Test:
• 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.

Locations

Country	Name	City	State
Netherlands	Rijnstate Hospital	Arnhem	Gelderland
Netherlands	Radboudumc	Nijmegen	Gelderland

Sponsors (2)

Lead Sponsor	Collaborator
Rijnstate Hospital	Radboud University

Country where clinical trial is conducted

Netherlands, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Demographic characteristics	Gender	Baseline
Other	Demographic characteristics	If current smoker	Baseline
Other	Demographic characteristics	Height	Baseline
Other	Demographic characteristics	Weight	Baseline
Other	Demographic characteristics	Medical history	Baseline
Other	Demographic characteristics	Blood pressure	Baseline
Other	Demographic characteristics	Heart rate	Baseline
Other	Medication use	Ask about: Statins	Baseline
Other	Medication use	Ask about: Beta-blockers	Baseline
Other	Medication use	Ask about: Sympathicomimetica	Baseline
Other	Medication use	Ask about: Anti-platelets	Baseline
Other	Medication use	Ask about: Anti-coagulants	Baseline
Other	Medication use	Ask about: Anti-hypertensives (questioned)	Baseline
Primary	CAR-test	Percentage of vasodilation/vasoconstriction to the CAR test at the common carotid artery	Baseline
Primary	CAR-test	Percentage of vasodilation/vasoconstriction to the CAR test at the abdominal aorta	Baseline
Secondary	CAR-test	Magnitude of the blood flow and perfusion response of the carotid artery	Baseline
Secondary	CAR-test	Timing of the blood flow and perfusion response of the carotid artery	Baseline
Secondary	CAR-test	Magnitude of the blood flow and perfusion response of the abdominal aorta	Baseline
Secondary	CAR-test	Timing of the blood flow and perfusion response of the abdominal aorta	Baseline
Secondary	CAR-test	Blood pressure response	Baseline
Secondary	CAR-test	Heart rate response	Baseline
Secondary	Age	Age	Baseline