Ignite Creation Date:
2024-05-06 @ 1:59 PM
Last Modification Date:
2024-10-26 @ 1:23 PM
Study NCT ID:
NCT04183426
Status:
RECRUITING
Last Update Posted:
2023-11-18
First Post:
2019-11-19
Brief Title:
Tonometry1 and Duplex Ultrasound2 to Predict CV Events in to be Treated Patients With an AAA
Sponsor:
Rijnstate Hospital
Organization:
Rijnstate Hospital
Study Overview
Official Title:
Tonometry1 and Duplex Ultrasound2 to Predict Cardiovascular Events in to be Treated Patients With an Abdominal Aortic Aneurysm One-Two-Treat Trial
Status:
RECRUITING
Status Verified Date:
2023-11
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:
One-Two-Treat
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 which are strongly linked to vascular health In 2013 the SMART risk score was developed to calculate the risk of the patients for recurrent vascular events based on clinical characteristics Recently a novel easy to perform non-invasive test of endothelial function the carotid artery reactivity CAR test reflecting target organ damage has been introduced The CAR is a simple quick 5-min non-invasive test that uses ultrasound to examine the carotid artery in response to sympathetic stimulation by placing one hand in cold water This test shows strong agreement with both coronary and aortic responses to sympathetic stimulation and predicted CV-events in patients with peripheral arterial disease
The aim of this prospective 2-year follow-up study is to investigate the predictive capacity of the CAR-test for development of CV-events after elective AAA repair in comparison to the SMART risk score Secondary objectives are to investigate the predictive capacity of arterial stiffness measurements and the post-operative CAR-test for development of CV-events and to evaluate health status scores to provide insight if these scores can support clinical decision making
The aim of this prospective 2-year follow-up study is to investigate the predictive capacity of the CAR-test for development of CV-events after elective AAA repair in comparison to the SMART risk score Secondary objectives are to investigate the predictive capacity of arterial stiffness measurements and the post-operative CAR-test for development of CV-events and to evaluate health status scores to provide insight if these scores can support clinical decision making
Detailed Description:
The investigators will include 194 patients with an AAA who will be scheduled for repair Participants will be recruited from all collaborating hospitals currently Radboudumc Rijnstate CWZ after providing written informed consent
In this observational prospective study a total of 194 patients who are going to be treated for their AAA will be included Baseline patient characteristics will be registered including traditional risk factors and CV-history In addition to regular care of measuring AAA diameter progression in mmyear we will perform the CAR-test 10-min and non-invasive arterial stiffness measures PWA and PWV with the SphygmoCor device 10-min
Furthermore the investigators will ask patients to complete a questionnaire about the quality of their life A second questionnaire tries to clarify the disease experience of the patients Both questionnaires will be asked to be completed at the start 6-8 weeks after repair after one year and after two years of repair Subsequently the investigators will record major adverse cardiovascular events MACE according to the International Classification of Disease-10 Registration of MACE will be performed using hospital-records and following international guidelines Across a 2-year follow-up by means of regular follow-up appointments the investigators will examine the ability of the CAR parameter and arterial stiffness parameters to predict CV-events
In this observational prospective study a total of 194 patients who are going to be treated for their AAA will be included Baseline patient characteristics will be registered including traditional risk factors and CV-history In addition to regular care of measuring AAA diameter progression in mmyear we will perform the CAR-test 10-min and non-invasive arterial stiffness measures PWA and PWV with the SphygmoCor device 10-min
Furthermore the investigators will ask patients to complete a questionnaire about the quality of their life A second questionnaire tries to clarify the disease experience of the patients Both questionnaires will be asked to be completed at the start 6-8 weeks after repair after one year and after two years of repair Subsequently the investigators will record major adverse cardiovascular events MACE according to the International Classification of Disease-10 Registration of MACE will be performed using hospital-records and following international guidelines Across a 2-year follow-up by means of regular follow-up appointments the investigators will examine the ability of the CAR parameter and arterial stiffness parameters to predict CV-events
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