Tonometry(1) and Duplex Ultrasound(2) to Predict Cardiovascular Events in to be Treated Patients With an Abdominal Aortic Aneurysm (One-Two-Treat Trial)

Status: Recruiting
Location: See all (7) locations...
Intervention Type: Diagnostic test
Study Type: Observational
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
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:

• 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;

Locations
Other Locations
Netherlands
Gelre Hospitals
RECRUITING
Apeldoorn
Deventer Hospital
RECRUITING
Deventer
Ziekenhuis Gelderse Vallei
RECRUITING
Ede
Medisch Spectrum Twente
RECRUITING
Enschede
Canisius Wilhelmina Ziekenhuis
RECRUITING
Nijmegen
Radboudumc
RECRUITING
Nijmegen
Maxima Medical Center
RECRUITING
Veldhoven
Contact Information
Primary
Michel Reijnen, MD, prof
MReijnen@rijnstate.nl
0880057282
Backup
Jenske Vermeulen, MSc.
JVermeulen@rijnstate.nl
0880057282
Time Frame
Start Date: 2020-06-12
Estimated Completion Date: 2027-06
Participants
Target number of participants: 194
Sponsors
Collaborators: Deventer Ziekenhuis, Maxima Medical Center, Medisch Spectrum Twente, Gelre Hospitals, Canisius-Wilhelmina Hospital, Radboud University Medical Center, Gelderse Vallei Hospital
Leads: Rijnstate Hospital

This content was sourced from clinicaltrials.gov