Tonometry and Duplex Ultrasound to Predict AAA Progression and CV Events in Aneurysm Patients (1-2-3 Trial)
Key facts
- Who runs it
- Rijnstate Hospital
- Where
- Netherlands3 sites in 1 countryChoose a country to see its sites
- Trial code
- Status
- Completed
- People taking part
- 167 people enrolled
- Started
- 1 Jul 2019
- Ended
- 1 Dec 2023
- Type of study
- Observational
- Treatments tested
- Carotid Artery Reactivity test (CAR test)
- Arterial stiffness
- Record updated
- 11 April 2024
Who can take part
- Sex
- Women and men
- Healthy volunteers
- Cannot take part
The registry criteria, word for word
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Who can take part
- Male or female at least 18 years old
- Informed consent form understood and signed and patient agrees to follow- up visits
- Has an abdominal aortic aneurysm (AAA), who is still under surveillance
Who cannot take part
- Psychiatric or other condition that may interfere with the study
- Presence of Raynaud's phenomenon, 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
- Life expectancy < 2 years
- Participating in another clinical study, interfering on outcomes
- Increased risk for coronary spasms (score Rose-questionnaire ≥2; this questionnaire can be found in Appendix 3)
This trial has no sites in United States.
It has sites in one country. Choose a country to see its sites.
About the trial
What the trial wants to find out
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.
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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.
Treatments tested
- Carotid Artery Reactivity test (CAR test)
- Arterial stiffness
Data and sources
- Registry record
- Listed on ClinicalTrials.gov.
- Official title
- Tonometry (1) and Duplex Ultrasound (2) to Predict Abdominal Aorta Aneurysm (3) Progression and Cardiovascular Events in Aneurysm Patients
- Record updated
- 11 April 2024