Tonometry and Duplex Ultrasound to Predict AAA Progression and CV Events in Aneurysm Patients (1-2-3 Trial)
Last updated on July 2021Recruitment
- Recruitment Status
- Recruiting
- Estimated Enrollment
- Same as current
Summary
- Conditions
- Abdominal Aortic Aneurysm
- Cardiovascular Events
- Type
- Observational
- Design
- Observational Model: CohortTime Perspective: Prospective
Participation Requirements
- Age
- Younger than 125 years
- Gender
- Both males and females
Description
The investigators will include 167 patients under surveillance for AAA who are all currently under the threshold for repair (i.e. 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 writte...
The investigators will include 167 patients under surveillance for AAA who are all currently under the threshold for repair (i.e. 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 (i.e. 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 mm/year), 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 mm/year) and the ability of the CAR parameter and arterial stiffness parameters to predict CV-events.
Tracking Information
- NCT #
- NCT03989011
- Collaborators
- Radboud University
- Canisius-Wilhelmina Hospital
- Investigators
- Principal Investigator: Michel Rijnen, MD, prof Rijnstate Hospital