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

November 15, 2023 updated by: Rijnstate Hospital

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

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.

Study Overview

Detailed Description

The investigators will include 194 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 194 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

Enrollment (Estimated)

194

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

Patients with an AAA who will be scheduled for repair, will be included. AAA patients will be recruited from all collaborating hospitals (Radboudumc, Rijnstate, CWZ), who provide written informed consent. Additionally, also 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.

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Prospective

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Major Adverse Cardiovascular Events (MACE)
Time Frame: 2-year follow-up
Incidence of MACE, including myocardial infarction, cerebral infarction, heart failure, rupture, and peripheral vascular disease
2-year follow-up

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
SMART Risk score
Time Frame: 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
Baseline
CAR-test results
Time Frame: Baseline and 6-weeks after operation
Percentage of vasodilation/vasoconstriction to the CAR test at the common carotid artery at baseline
Baseline and 6-weeks after operation
CAR-test results
Time Frame: Baseline and 6-weeks after operation
Magnitude of the blood flow and perfusion response
Baseline and 6-weeks after operation
CAR-test results
Time Frame: Baseline and 6-weeks after operation
Timing of the blood flow and perfusion response
Baseline and 6-weeks after operation
CAR-test results
Time Frame: Baseline and 6-weeks after operation
Blood pressure responses
Baseline and 6-weeks after operation
CAR-test results
Time Frame: Baseline and 6-weeks after operation
Heart rate responses
Baseline and 6-weeks after operation
CAR-test results
Time Frame: Baseline and 6-weeks after operation
Changes after treatment
Baseline and 6-weeks after operation
SphygmoCor parameters
Time Frame: Baseline, 6-weeks, 1 year and 2 year after operation
Peripheral pressure measurements (PWA)
Baseline, 6-weeks, 1 year and 2 year after operation
SphygmoCor parameters
Time Frame: Baseline, 6-weeks, 1 year and 2 year after operation
Central pressure measurements (derived using a transfer function, PWA)
Baseline, 6-weeks, 1 year and 2 year after operation
SphygmoCor parameters
Time Frame: Baseline, 6-weeks, 1 year and 2 year after operation
Abdominal pressure measurements (derived using a transfer function, PWA)
Baseline, 6-weeks, 1 year and 2 year after operation
SphygmoCor parameters
Time Frame: Baseline, 6-weeks, 1 year and 2 year after operation
SEVR
Baseline, 6-weeks, 1 year and 2 year after operation
SphygmoCor parameters
Time Frame: Baseline, 6-weeks, 1 year and 2 year after operation
ED
Baseline, 6-weeks, 1 year and 2 year after operation
SphygmoCor parameters
Time Frame: Baseline, 6-weeks, 1 year and 2 year after operation
PWV
Baseline, 6-weeks, 1 year and 2 year after operation
SphygmoCor parameters
Time Frame: Baseline and 6-weeks after operation
Change in Peripheral pressure measurements (PWA) after treatment
Baseline and 6-weeks after operation
SphygmoCor parameters
Time Frame: Baseline and 6-weeks after operation
Change in Central pressure measurements (derived using a transfer function, PWA) after treatment
Baseline and 6-weeks after operation
SphygmoCor parameters
Time Frame: Baseline and 6-weeks after operation
Change in Abdominal pressure measurements (derived using a transfer function, PWA) after treatment
Baseline and 6-weeks after operation
SphygmoCor parameters
Time Frame: Baseline and 6-weeks after operation
Change in SEVR after treatment
Baseline and 6-weeks after operation
SphygmoCor parameters
Time Frame: Baseline and 6-weeks after operation
Change in ED after treatment
Baseline and 6-weeks after operation
SphygmoCor parameters
Time Frame: Baseline and 6-weeks after operation
Change in PWV after treatment
Baseline and 6-weeks after operation
Score EQ-5D questionnaire
Time Frame: Baseline, 6-weeks, 1 year and 2 year after operation
Patient reported outcomes measured by the general health questionnaire
Baseline, 6-weeks, 1 year and 2 year after operation
Score IPQ-K questionnaire
Time Frame: Baseline, 6-weeks, 1 year and 2 year after operation
Patient reported outcomes measured by the disease perception questionnaire
Baseline, 6-weeks, 1 year and 2 year after operation

Other Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

June 12, 2020

Primary Completion (Estimated)

December 1, 2026

Study Completion (Estimated)

June 1, 2027

Study Registration Dates

First Submitted

November 19, 2019

First Submitted That Met QC Criteria

November 28, 2019

First Posted (Actual)

December 3, 2019

Study Record Updates

Last Update Posted (Estimated)

November 16, 2023

Last Update Submitted That Met QC Criteria

November 15, 2023

Last Verified

November 1, 2023

More Information

Terms related to this study

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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