Tonometry(1) and Duplex Ultrasound(2) to Predict CV Events in to be Treated Patients With an AAA

Launched by RIJNSTATE HOSPITAL · Nov 28, 2019

Keywords

ClinConnect Summary

This clinical trial is studying how well a new, simple test called the carotid artery reactivity (CAR) test can predict serious heart and blood vessel events in patients who are having surgery to repair an abdominal aortic aneurysm (AAA). An AAA is a bulge in the large blood vessel that carries blood from the heart to the rest of the body, and it can be dangerous if it bursts. The trial will compare the CAR test results with a previously developed risk score called the SMART score, which helps doctors estimate a patient’s risk of future vascular problems based on their health history.

To participate in this study, you need to be at least 18 years old and have an AAA that is scheduled for elective repair. You’ll need to understand and sign a consent form agreeing to take part in follow-up visits. Participants will undergo the CAR test, which is quick and non-invasive, and involves placing one hand in cold water to see how your carotid artery responds. The study aims to help doctors better predict which patients are at higher risk for heart and blood vessel events after their surgery, potentially leading to improved care.

Gender

ALL

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.