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RecruitingNCT04183426One-Two-TreatUpdated Mar 6, 2025

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

An observational study in Abdominal Aortic Aneurysm and Cardiovascular Events, sponsored by Rijnstate Hospital. Recruiting at 7 sites in Netherlands. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2025-03-06.

Sponsored by Rijnstate Hospital · Observational

From the registry’s dates

  • Started Jun 2020; still recruiting 6 years 3 months later.
Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
194
Ages
18 Years and older
Sex
All
01

Study 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.

Read the 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.

02

Conditions studied

  • Abdominal Aortic Aneurysm
  • Cardiovascular Events

Keywords

  • Functional Response
  • Abdominal Aortic Aneurysm
  • Cardiovascular Events
03

In context

Aneurysm

960 studies on the registry are indexed under Aneurysm; 175 are open to participants now.

This study's planned enrollment of 194 is above the median of 151 across 443 observational studies indexed under Aneurysm.

Browse Aneurysm studies →

Lead sponsor

Rijnstate Hospital is the lead sponsor of 127 studies on the registry; 14 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
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.

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

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.
05

Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
194 participants (estimated)
Patient registry
No

Interventions

  • Diagnostic testCarotid Artery Reactivity test (CAR test)

    The CAR test will be applied to stimulate the sympathetic nervous system. This thermal stimulus is known to elevate blood pressure via sympathetic pathways, so it can be used to study the vascular response to sympathetic activation. The participant will submerge their left hand in a bucket of ice water (approximately 4 degrees celcius) for 3 minutes, which is reported to be sufficient to induce a maximal dilation in the common carotid artery. At baseline and every minute after the hand is submerged in ice water, the blood pressure will be measured to check whether a sympathetic stimulation is achieved.

  • Diagnostic testArterial Stiffness

    The SphygmoCor device will be used to non-invasively measure arterial stiffness parameters using applanation tonometry. For Pulse Wave Analyses (PWA), the radial waveform will be recorded. Approximately 10 waveforms are averaged, resulting in several non-invasive parameters: * Peripheral pressure parameters * Central and abdominal aneurysm pressure parameters (derived using a transfer function) * Cardiac output parameters (sub-endocardial viability ratio (SEVR), Ejection Duration (ED)) Pulse wave velocity will be performed by recording the waveforms of the carotid and femoral artery sequentially. The travelled distance will be measured according to the current guidelines and entered in the program. The program will calculate the PWV based on 10 ECG triggered waveform of each artery.

06

What researchers measure

Primary outcomes

  1. Major Adverse Cardiovascular Events (MACE)

    Incidence of MACE, including myocardial infarction, cerebral infarction, heart failure, rupture, and peripheral vascular disease

    Time frame: 2-year follow-up

Secondary outcomes

  1. SMART Risk score

    Second Manifestations of ARTerial disease risk score is developed to determine the risk of recurrent vascular events based on clinical characteristics of the patients

    Time frame: Baseline

  2. CAR-test results

    Percentage of vasodilation/vasoconstriction to the CAR test at the common carotid artery at baseline

    Time frame: Baseline and 6-weeks after operation

  3. CAR-test results

    Magnitude of the blood flow and perfusion response

    Time frame: Baseline and 6-weeks after operation

  4. CAR-test results

    Timing of the blood flow and perfusion response

    Time frame: Baseline and 6-weeks after operation

  5. CAR-test results

    Blood pressure responses

    Time frame: Baseline and 6-weeks after operation

  6. CAR-test results

    Heart rate responses

    Time frame: Baseline and 6-weeks after operation

  7. CAR-test results

    Changes after treatment

    Time frame: Baseline and 6-weeks after operation

  8. SphygmoCor parameters

    Peripheral pressure measurements (PWA)

    Time frame: Baseline, 6-weeks, 1 year and 2 year after operation

  9. SphygmoCor parameters

    Central pressure measurements (derived using a transfer function, PWA)

    Time frame: Baseline, 6-weeks, 1 year and 2 year after operation

  10. SphygmoCor parameters

    Abdominal pressure measurements (derived using a transfer function, PWA)

    Time frame: Baseline, 6-weeks, 1 year and 2 year after operation

  11. SphygmoCor parameters

    SEVR

    Time frame: Baseline, 6-weeks, 1 year and 2 year after operation

  12. SphygmoCor parameters

    ED

    Time frame: Baseline, 6-weeks, 1 year and 2 year after operation

  13. SphygmoCor parameters

    PWV

    Time frame: Baseline, 6-weeks, 1 year and 2 year after operation

  14. SphygmoCor parameters

    Change in Peripheral pressure measurements (PWA) after treatment

    Time frame: Baseline and 6-weeks after operation

  15. SphygmoCor parameters

    Change in Central pressure measurements (derived using a transfer function, PWA) after treatment

    Time frame: Baseline and 6-weeks after operation

  16. SphygmoCor parameters

    Change in Abdominal pressure measurements (derived using a transfer function, PWA) after treatment

    Time frame: Baseline and 6-weeks after operation

  17. SphygmoCor parameters

    Change in SEVR after treatment

    Time frame: Baseline and 6-weeks after operation

  18. SphygmoCor parameters

    Change in ED after treatment

    Time frame: Baseline and 6-weeks after operation

  19. SphygmoCor parameters

    Change in PWV after treatment

    Time frame: Baseline and 6-weeks after operation

  20. Score EQ-5D questionnaire

    Patient reported outcomes measured by the general health questionnaire

    Time frame: Baseline, 6-weeks, 1 year and 2 year after operation

  21. Score IPQ-K questionnaire

    Patient reported outcomes measured by the disease perception questionnaire

    Time frame: Baseline, 6-weeks, 1 year and 2 year after operation

Other outcomes

  1. Demographic characteristics

    Age

    Time frame: Baseline

  2. Demographic characteristics

    Gender

    Time frame: Baseline

  3. Demographic characteristics

    If current smoker

    Time frame: Baseline

  4. Demographic characteristics

    Height

    Time frame: Baseline

  5. Demographic characteristics

    Weight

    Time frame: Baseline

  6. Demographic characteristics

    ASA class

    Time frame: Baseline

  7. Demographic characteristics

    Medical history

    Time frame: Baseline

  8. Demographic characteristics

    Blood pressure

    Time frame: Baseline

  9. Demographic characteristics

    Heart rate

    Time frame: Baseline

  10. Demographic characteristics

    Cardiac measurements

    Time frame: Baseline

  11. Demographic characteristics

    SVS class

    Time frame: Baseline

  12. Preoperative anatomic characteristics before primary repair procedure

    AAA sac diameter

    Time frame: Baseline

  13. Preoperative anatomic characteristics before primary repair procedure

    Infrarenal aortic neck lumen diameter

    Time frame: Baseline

  14. Preoperative anatomic characteristics before primary repair procedure

    Proximal non-aneurysmal aortic neck length

    Time frame: Baseline

  15. Preoperative anatomic characteristics before primary repair procedure

    Proximal aortic neck angle

    Time frame: Baseline

  16. Preoperative anatomic characteristics before primary repair procedure

    Aneurysm blood lumen diameter

    Time frame: Baseline

  17. Preoperative anatomic characteristics before primary repair procedure

    Common iliac artery diameters

    Time frame: Baseline

  18. Preoperative anatomic characteristics before primary repair procedure

    Blood lumen diameter

    Time frame: Baseline

  19. Procedure and discharge details of intervention

    Type of procedure

    Time frame: At time of procedure

  20. Procedure and discharge details of intervention

    Anesthesia type

    Time frame: At time of procedure

  21. Procedure and discharge details of intervention

    Access type

    Time frame: At time of procedure

  22. Procedure and discharge details of intervention

    Used stent lengths

    Time frame: At time of procedure

  23. Procedure and discharge details of intervention

    Contrast volume used

    Time frame: At time of procedure

  24. Procedure and discharge details of intervention

    Total procedure time

    Time frame: At time of procedure

  25. Procedure and discharge details of intervention

    Immediate procedural technical success

    Time frame: At time of procedure

  26. Procedure and discharge details of intervention

    Complications pre procedure

    Time frame: During procedure

  27. Procedure and discharge details of intervention

    Complications post procedure

    Time frame: Up to 2 years

  28. Procedure and discharge details of intervention

    Additional procedures estimated blood loss

    Time frame: During procedure

  29. Procedure and discharge details of intervention

    Blood transfusion

    Time frame: During procedure

  30. Procedure and discharge details of intervention

    Concomitant procedures

    Time frame: Up to 2 years

  31. Procedure and discharge details of intervention

    Time in ICU

    Time frame: After procedure till discharge

  32. Procedure and discharge details of intervention

    Time to hospital discharge

    Time frame: After procedure till discharge

  33. Medications

    Dose of Anti-platelets

    Time frame: During 2-year follow up

  34. Medications

    Dose of Anti-coagulants

    Time frame: During 2-year follow up

  35. Medications

    Dose of Anti-hypertensives

    Time frame: During 2-year follow up

  36. Medications

    Dose of Statins

    Time frame: During 2-year follow up

  37. Medications

    Dose of Beta-blockers

    Time frame: During 2-year follow up

  38. Medications

    Dose of Sympathicomimetics

    Time frame: During 2-year follow up

  39. Laboratory test results

    Hemoglobin

    Time frame: 2-year follow-up

  40. Laboratory test results

    Serum creatinine

    Time frame: 2-year follow-up

  41. Laboratory test results

    Cholesterol

    Time frame: 2-year follow-up

  42. Laboratory test results

    eGFR

    Time frame: 2-year follow-up

  43. Laboratory test results

    CRP

    Time frame: 2-year follow-up

  44. Parameters during follow-up

    Any type of endoleak

    Time frame: 2-year follow-up

  45. Parameters during follow-up

    AAA sac expansion

    Time frame: 2-year follow-up

  46. Parameters during follow-up

    Any other (S)AE

    Time frame: 2-year follow-up

07

Study locations

7 of 7 sites recruiting
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Mar 6, 2025, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT04183426
Lead sponsor
Rijnstate Hospital
Collaborators
Radboud University Medical Center, Canisius-Wilhelmina Hospital, Gelderse Vallei Hospital, Medisch Spectrum Twente, Deventer Ziekenhuis, Gelre Hospitals, Maxima Medical Center
Responsible party
Sponsor
First posted
Dec 3, 2019
Start date
Jun 12, 2020
Primary completion
Dec 2026 (estimated)
Completion
Jun 2027 (estimated)
Last update
Mar 6, 2025

Study contacts

Michel Reijnen, MD, prof
Contact
MReijnen@rijnstate.nl
0880057282
Jenske Vermeulen, MSc.
Contact
JVermeulen@rijnstate.nl
0880057282
Michel Reijnen, MD, prof
principal investigator · Rijnstate Hospital

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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