NCT04183426 Tonometry(1) and Duplex Ultrasound(2) to Predict CV Events in to be Treated Patients With an AAA
| NCT ID | NCT04183426 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Rijnstate Hospital |
| Condition | Abdominal Aortic Aneurysm |
| Study Type | OBSERVATIONAL |
| Enrollment | 194 participants |
| Start Date | 2020-06-12 |
| Primary Completion | 2026-12 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
This is an observational study. You will not receive an experimental treatment; researchers will collect data based on your existing condition or standard treatment.
This trial targets 194 participants in total. It began in 2020-06-12 with a primary completion date of 2026-12.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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.
Eligibility Criteria
Inclusion Criteria: * Male or female at least 18 years old; * Informed consent form understood and signed and patient agrees to follow- up visits; * Has an infrarenal or juxtarenal abdominal aortic aneurysm (AAA), scheduled for elective repair (i.e open repair, EVAR, FEVAR and CHEVAR) according to standard practice; Exclusion Criteria: * Life expectancy \< 2 years; * Psychiatric or other condition that may interfere with the study; * Participating in another clinical study, interfering on outcomes; * Increased risk for coronary spasms (score Rose-questionnaire ≥2; * 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.
Contact & Investigator
Michel Reijnen, MD, prof
PRINCIPAL INVESTIGATOR
Rijnstate Hospital
Frequently Asked Questions
Who can join the NCT04183426 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Abdominal Aortic Aneurysm. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT04183426 currently recruiting?
Yes, NCT04183426 is actively recruiting participants. Contact the research team at MReijnen@rijnstate.nl for enrollment information.
Where is the NCT04183426 trial being conducted?
This trial is being conducted at Nijmegen, Netherlands, Nijmegen, Netherlands, Apeldoorn, Netherlands, Deventer, Netherlands and 3 additional locations.
Who is sponsoring the NCT04183426 clinical trial?
NCT04183426 is sponsored by Rijnstate Hospital. The principal investigator is Michel Reijnen, MD, prof at Rijnstate Hospital. The trial plans to enroll 194 participants.