Ignite Creation Date:
2024-05-06 @ 1:18 PM
Last Modification Date:
2024-10-26 @ 1:12 PM
Study NCT ID:
NCT03989011
Status:
COMPLETED
Last Update Posted:
2024-04-11
First Post:
2019-05-29
Brief Title:
Tonometry and Duplex Ultrasound to Predict AAA Progression and CV Events in Aneurysm Patients 1-2-3 Trial
Sponsor:
Rijnstate Hospital
Organization:
Rijnstate Hospital
Study Overview
Official Title:
Tonometry 1 and Duplex Ultrasound 2 to Predict Abdominal Aorta Aneurysm 3 Progression and Cardiovascular Events in Aneurysm Patients
Status:
COMPLETED
Status Verified Date:
2024-04
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:
None
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 highlighting the need to explore the potential of novel techniques Both progression of AAA and CV events are strongly linked to vascular health In 2013 the SMART risk score is 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 recently 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 in comparison to the SMART risk score for the development of cardiovascular events in patients with an abdominal aortic aneurysm who have not yet reached the treatment threshold This could aid clinical decision making in the need for surgical intervention but also alter drug treatment to reduce risk of cardiovascular events Secondary objectives are to investigate the predictive capacity of the CAR-test for progression of the abdominal aortic aneurysm and to evaluate QoL scores in patients under surveillance for AAA The aim is to provide insight if these scores can help clinical decision making
The aim of this prospective 2-year follow-up study is to investigate the predictive capacity of the CAR-test in comparison to the SMART risk score for the development of cardiovascular events in patients with an abdominal aortic aneurysm who have not yet reached the treatment threshold This could aid clinical decision making in the need for surgical intervention but also alter drug treatment to reduce risk of cardiovascular events Secondary objectives are to investigate the predictive capacity of the CAR-test for progression of the abdominal aortic aneurysm and to evaluate QoL scores in patients under surveillance for AAA The aim is to provide insight if these scores can help clinical decision making
Detailed Description:
The investigators will include 167 patients under surveillance for AAA who are all currently under the threshold for repair ie AAA diameter 40-50 mm for men and 35-45 mm for women Participants will be recruited from all collaborating hospitals Radboudumc Rijnstate CWZ after providing written informed consent Additionally AAA-patients under surveillance of general practitioners are eligible and will be contacted through the hospital-links since the nature of the tests allow for performing all tests at the general practitioners office
In this observational prospective study a total of 167 patients under surveillance for an AAA who are currently under threshold for repair ie AAA diameter 40-50 mm for men and 35-44 mm for women 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 the investigators will perform the CAR-test 10-min and non-invasive arterial stiffness measures PWA and PWV with the SphygmoCor device 10-min one time as baseline Furthermore the investigators will ask patients to complete a questionnaire about the quality of their life Appendix 1 A second questionnaire tries to clarify the disease experience of the patients and can be found in Appendix 2 Both questionnaires will be asked to be completed at the start and the end of the study 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 AAA progression in mmyear and the ability of the CAR parameter and arterial stiffness parameters to predict CV-events
In this observational prospective study a total of 167 patients under surveillance for an AAA who are currently under threshold for repair ie AAA diameter 40-50 mm for men and 35-44 mm for women 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 the investigators will perform the CAR-test 10-min and non-invasive arterial stiffness measures PWA and PWV with the SphygmoCor device 10-min one time as baseline Furthermore the investigators will ask patients to complete a questionnaire about the quality of their life Appendix 1 A second questionnaire tries to clarify the disease experience of the patients and can be found in Appendix 2 Both questionnaires will be asked to be completed at the start and the end of the study 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 AAA progression in mmyear and 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