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

May 27, 2020checkorphan

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Cook – Abdominal aortic aneurysm Cordis Corporation – Abdominal Aortic Aneurysm

Related Clinical Trial

Brief Title

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

Official Title

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

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.

Detailed Description

The investigators will include 192 patients with an AAA who will be scheduled for repair.
Participants will be recruited from all collaborating hospitals (currently Radboudumc,
Rijnstate, CWZ) after providing written informed consent.

In this observational, prospective study, a total of 192 patients who are going to be treated
for their AAA 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), we will perform the CAR-test (10-min) and non-invasive
arterial stiffness measures (PWA and PWV) with the SphygmoCor device (10-min).

Furthermore, the investigators will ask patients to complete a questionnaire about the
quality of their life. A second questionnaire tries to clarify the disease experience of the
patients. Both questionnaires will be asked to be completed at the start, 6-8 weeks after
repair, after one year and after two years of repair. 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 the ability of the CAR parameter and
arterial stiffness parameters to predict CV-events.

Study Type

Observational

Primary Outcome

Major Adverse Cardiovascular Events (MACE)

Secondary Outcome

 SMART Risk score

Condition

Abdominal Aortic Aneurysm

Intervention

Carotid Artery Reactivity test (CAR test)

Publications

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information

Recruitment Status

Diagnostic Test

Estimated Enrollment

Start Date

June 12, 2020

Completion Date

December 2024

Primary Completion Date

December 2022

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.

Gender

All

Ages

18 Years - N/A

Accepts Healthy Volunteers

No

Contacts

Michel Reijnen, MD, prof, 0880057282, [email protected]

Location Countries

Netherlands

Location Countries

Netherlands

Administrative Informations

NCT ID

NCT04183426

Organization ID

One-Two-Treat Trial

Responsible Party

Sponsor

Study Sponsor

Rijnstate Hospital

Collaborators

 Radboud University Medical Center

Study Sponsor

Michel Reijnen, MD, prof, Principal Investigator, Rijnstate Hospital

Verification Date

October 2020