Viewing Study NCT04035252



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Last Modification Date: 2024-10-26 @ 1:15 PM
Study NCT ID: NCT04035252
Status: COMPLETED
Last Update Posted: 2020-10-12
First Post: 2019-07-25

Brief Title: Relation betwEen Abdominal Aorta and Carotid Artery Responses to SymPathetic stimulatiON uSing duplEx Ultrasound
Sponsor: Rijnstate Hospital
Organization: Rijnstate Hospital

Study Overview

Official Title: Relation betwEen Abdominal Aorta and Carotid Artery Responses to SymPathetic stimulatiON uSing duplEx Ultrasound
Status: COMPLETED
Status Verified Date: 2020-10
Last Known Status: None
Delayed Posting: No
If Stopped, Why?: Not Stopped
Has Expanded Access: False
If Expanded Access, NCT#: N/A
Has Expanded Access, NCT# Status: N/A
Acronym: RESPONSE
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 ie 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 ie 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 Oversight

Has Oversight DMC: None
Is a FDA Regulated Drug?: False
Is a FDA Regulated Device?: False
Is an Unapproved Device?: None
Is a PPSD?: None
Is a US Export?: None
Is an FDA AA801 Violation?: None