One-Two-Treat: Tonometry(1) and Duplex Ultrasound(2) to Predict CV Events in to be Treated Patients With an AAA

Sponsor

Rijnstate Hospital (Other)

Overall Status

Recruiting

CT.gov ID

NCT04183426

Collaborator

Radboud University Medical Center (Other), Canisius-Wilhelmina Hospital (Other)

192

Enrollment

Locations

53.7

Anticipated Duration (Months)

Patients Per Site

1.8

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Abdominal Aortic Aneurysm Cardiovascular Events	Diagnostic Test: Carotid Artery Reactivity test (CAR test) Diagnostic Test: Arterial Stiffness

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 Design

Study Type:

Observational

Anticipated Enrollment :

192 participants

Observational Model:

Cohort

Time Perspective:

Prospective

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)

Actual Study Start Date :

Jun 12, 2020

Anticipated Primary Completion Date :

Dec 1, 2022

Anticipated Study Completion Date :

Dec 1, 2024

Outcome Measures

Primary Outcome Measures

Major Adverse Cardiovascular Events (MACE) [2-year follow-up]
Incidence of MACE, including myocardial infarction, cerebral infarction, heart failure, rupture, and peripheral vascular disease

Secondary Outcome Measures

SMART Risk score [Baseline]
Second Manifestations of ARTerial disease risk score is developed to determine the risk of recurrent vascular events based on clinical characteristics of the patients
CAR-test results [Baseline and 6-weeks after operation]
Percentage of vasodilation/vasoconstriction to the CAR test at the common carotid artery at baseline
CAR-test results [Baseline and 6-weeks after operation]
Magnitude of the blood flow and perfusion response
CAR-test results [Baseline and 6-weeks after operation]
Timing of the blood flow and perfusion response
CAR-test results [Baseline and 6-weeks after operation]
Blood pressure responses
CAR-test results [Baseline and 6-weeks after operation]
Heart rate responses
CAR-test results [Baseline and 6-weeks after operation]
Changes after treatment
SphygmoCor parameters [Baseline, 6-weeks, 1 year and 2 year after operation]
Peripheral pressure measurements (PWA)
SphygmoCor parameters [Baseline, 6-weeks, 1 year and 2 year after operation]
Central pressure measurements (derived using a transfer function, PWA)
SphygmoCor parameters [Baseline, 6-weeks, 1 year and 2 year after operation]
Abdominal pressure measurements (derived using a transfer function, PWA)
SphygmoCor parameters [Baseline, 6-weeks, 1 year and 2 year after operation]
SEVR
SphygmoCor parameters [Baseline, 6-weeks, 1 year and 2 year after operation]
ED
SphygmoCor parameters [Baseline, 6-weeks, 1 year and 2 year after operation]
PWV
SphygmoCor parameters [Baseline and 6-weeks after operation]
Change in Peripheral pressure measurements (PWA) after treatment
SphygmoCor parameters [Baseline and 6-weeks after operation]
Change in Central pressure measurements (derived using a transfer function, PWA) after treatment
SphygmoCor parameters [Baseline and 6-weeks after operation]
Change in Abdominal pressure measurements (derived using a transfer function, PWA) after treatment
SphygmoCor parameters [Baseline and 6-weeks after operation]
Change in SEVR after treatment
SphygmoCor parameters [Baseline and 6-weeks after operation]
Change in ED after treatment
SphygmoCor parameters [Baseline and 6-weeks after operation]
Change in PWV after treatment
Score EQ-5D questionnaire [Baseline, 6-weeks, 1 year and 2 year after operation]
Patient reported outcomes measured by the general health questionnaire
Score IPQ-K questionnaire [Baseline, 6-weeks, 1 year and 2 year after operation]
Patient reported outcomes measured by the disease perception questionnaire

Other Outcome Measures

Demographic characteristics [Baseline]
Age
Demographic characteristics [Baseline]
Gender
Demographic characteristics [Baseline]
If current smoker
Demographic characteristics [Baseline]
Height
Demographic characteristics [Baseline]
Weight
Demographic characteristics [Baseline]
ASA class
Demographic characteristics [Baseline]
Medical history
Demographic characteristics [Baseline]
Blood pressure
Demographic characteristics [Baseline]
Heart rate
Demographic characteristics [Baseline]
Cardiac measurements
Demographic characteristics [Baseline]
SVS class
Preoperative anatomic characteristics before primary repair procedure [Baseline]
AAA sac diameter
Preoperative anatomic characteristics before primary repair procedure [Baseline]
Infrarenal aortic neck lumen diameter
Preoperative anatomic characteristics before primary repair procedure [Baseline]
Proximal non-aneurysmal aortic neck length
Preoperative anatomic characteristics before primary repair procedure [Baseline]
Proximal aortic neck angle
Preoperative anatomic characteristics before primary repair procedure [Baseline]
Aneurysm blood lumen diameter
Preoperative anatomic characteristics before primary repair procedure [Baseline]
Common iliac artery diameters
Preoperative anatomic characteristics before primary repair procedure [Baseline]
Blood lumen diameter
Procedure and discharge details of intervention [At time of procedure]
Type of procedure
Procedure and discharge details of intervention [At time of procedure]
Anesthesia type
Procedure and discharge details of intervention [At time of procedure]
Access type
Procedure and discharge details of intervention [At time of procedure]
Used stent lengths
Procedure and discharge details of intervention [At time of procedure]
Contrast volume used
Procedure and discharge details of intervention [At time of procedure]
Total procedure time
Procedure and discharge details of intervention [At time of procedure]
Immediate procedural technical success
Procedure and discharge details of intervention [During procedure]
Complications pre procedure
Procedure and discharge details of intervention [Up to 2 years]
Complications post procedure
Procedure and discharge details of intervention [During procedure]
Additional procedures estimated blood loss
Procedure and discharge details of intervention [During procedure]
Blood transfusion
Procedure and discharge details of intervention [Up to 2 years]
Concomitant procedures
Procedure and discharge details of intervention [After procedure till discharge]
Time in ICU
Procedure and discharge details of intervention [After procedure till discharge]
Time to hospital discharge
Medications [During 2-year follow up]
Dose of Anti-platelets
Medications [During 2-year follow up]
Dose of Anti-coagulants
Medications [During 2-year follow up]
Dose of Anti-hypertensives
Medications [During 2-year follow up]
Dose of Statins
Medications [During 2-year follow up]
Dose of Beta-blockers
Medications [During 2-year follow up]
Dose of Sympathicomimetics
Laboratory test results [2-year follow-up]
Hemoglobin
Laboratory test results [2-year follow-up]
Serum creatinine
Laboratory test results [2-year follow-up]
Cholesterol
Laboratory test results [2-year follow-up]
eGFR
Laboratory test results [2-year follow-up]
CRP
Parameters during follow-up [2-year follow-up]
Any type of endoleak
Parameters during follow-up [2-year follow-up]
AAA sac expansion
Parameters during follow-up [2-year follow-up]
Any other (S)AE

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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.