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NCT Number: NCT04183426

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

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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Canisius Wilhelmina Ziekenhuis, Nijmegen, Gelderland, Netherlands

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Carotid Artery Reactivity test (CAR test)

Diagnostic 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.

Arterial Stiffness

Diagnostic Test

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.

Primary outcomes

  1. 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

Secondary outcomes

  1. 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

  2. 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

  3. CAR-test results

    Time frame: Baseline and 6-weeks after operation

    Magnitude of the blood flow and perfusion response

  4. CAR-test results

    Time frame: Baseline and 6-weeks after operation

    Timing of the blood flow and perfusion response

  5. CAR-test results

    Time frame: Baseline and 6-weeks after operation

    Blood pressure responses

  6. CAR-test results

    Time frame: Baseline and 6-weeks after operation

    Heart rate responses

  7. CAR-test results

    Time frame: Baseline and 6-weeks after operation

    Changes after treatment

  8. SphygmoCor parameters

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

    Peripheral pressure measurements (PWA)

  9. SphygmoCor parameters

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

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

  10. SphygmoCor parameters

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

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

  11. SphygmoCor parameters

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

    SEVR

  12. SphygmoCor parameters

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

    ED

  13. SphygmoCor parameters

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

    PWV

  14. SphygmoCor parameters

    Time frame: Baseline and 6-weeks after operation

    Change in Peripheral pressure measurements (PWA) after treatment

  15. SphygmoCor parameters

    Time frame: Baseline and 6-weeks after operation

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

  16. SphygmoCor parameters

    Time frame: Baseline and 6-weeks after operation

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

  17. SphygmoCor parameters

    Time frame: Baseline and 6-weeks after operation

    Change in SEVR after treatment

  18. SphygmoCor parameters

    Time frame: Baseline and 6-weeks after operation

    Change in ED after treatment

  19. SphygmoCor parameters

    Time frame: Baseline and 6-weeks after operation

    Change in PWV after treatment

  20. 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

  21. 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

Other outcomes

  1. Demographic characteristics

    Time frame: Baseline

    Age

  2. Demographic characteristics

    Time frame: Baseline

    Gender

  3. Demographic characteristics

    Time frame: Baseline

    If current smoker

  4. Demographic characteristics

    Time frame: Baseline

    Height

  5. Demographic characteristics

    Time frame: Baseline

    Weight

  6. Demographic characteristics

    Time frame: Baseline

    ASA class

  7. Demographic characteristics

    Time frame: Baseline

    Medical history

  8. Demographic characteristics

    Time frame: Baseline

    Blood pressure

  9. Demographic characteristics

    Time frame: Baseline

    Heart rate

  10. Demographic characteristics

    Time frame: Baseline

    Cardiac measurements

  11. Demographic characteristics

    Time frame: Baseline

    SVS class

  12. Preoperative anatomic characteristics before primary repair procedure

    Time frame: Baseline

    AAA sac diameter

  13. Preoperative anatomic characteristics before primary repair procedure

    Time frame: Baseline

    Infrarenal aortic neck lumen diameter

  14. Preoperative anatomic characteristics before primary repair procedure

    Time frame: Baseline

    Proximal non-aneurysmal aortic neck length

  15. Preoperative anatomic characteristics before primary repair procedure

    Time frame: Baseline

    Proximal aortic neck angle

  16. Preoperative anatomic characteristics before primary repair procedure

    Time frame: Baseline

    Aneurysm blood lumen diameter

  17. Preoperative anatomic characteristics before primary repair procedure

    Time frame: Baseline

    Common iliac artery diameters

  18. Preoperative anatomic characteristics before primary repair procedure

    Time frame: Baseline

    Blood lumen diameter

  19. Procedure and discharge details of intervention

    Time frame: At time of procedure

    Type of procedure

  20. Procedure and discharge details of intervention

    Time frame: At time of procedure

    Anesthesia type

  21. Procedure and discharge details of intervention

    Time frame: At time of procedure

    Access type

  22. Procedure and discharge details of intervention

    Time frame: At time of procedure

    Used stent lengths

  23. Procedure and discharge details of intervention

    Time frame: At time of procedure

    Contrast volume used

  24. Procedure and discharge details of intervention

    Time frame: At time of procedure

    Total procedure time

  25. Procedure and discharge details of intervention

    Time frame: At time of procedure

    Immediate procedural technical success

  26. Procedure and discharge details of intervention

    Time frame: During procedure

    Complications pre procedure

  27. Procedure and discharge details of intervention

    Time frame: Up to 2 years

    Complications post procedure

  28. Procedure and discharge details of intervention

    Time frame: During procedure

    Additional procedures estimated blood loss

  29. Procedure and discharge details of intervention

    Time frame: During procedure

    Blood transfusion

  30. Procedure and discharge details of intervention

    Time frame: Up to 2 years

    Concomitant procedures

  31. Procedure and discharge details of intervention

    Time frame: After procedure till discharge

    Time in ICU

  32. Procedure and discharge details of intervention

    Time frame: After procedure till discharge

    Time to hospital discharge

  33. Medications

    Time frame: During 2-year follow up

    Dose of Anti-platelets

  34. Medications

    Time frame: During 2-year follow up

    Dose of Anti-coagulants

  35. Medications

    Time frame: During 2-year follow up

    Dose of Anti-hypertensives

  36. Medications

    Time frame: During 2-year follow up

    Dose of Statins

  37. Medications

    Time frame: During 2-year follow up

    Dose of Beta-blockers

  38. Medications

    Time frame: During 2-year follow up

    Dose of Sympathicomimetics

  39. Laboratory test results

    Time frame: 2-year follow-up

    Hemoglobin

  40. Laboratory test results

    Time frame: 2-year follow-up

    Serum creatinine

  41. Laboratory test results

    Time frame: 2-year follow-up

    Cholesterol

  42. Laboratory test results

    Time frame: 2-year follow-up

    eGFR

  43. Laboratory test results

    Time frame: 2-year follow-up

    CRP

  44. Parameters during follow-up

    Time frame: 2-year follow-up

    Any type of endoleak

  45. Parameters during follow-up

    Time frame: 2-year follow-up

    AAA sac expansion

  46. Parameters during follow-up

    Time frame: 2-year follow-up

    Any other (S)AE

Study contacts

Contact information is provided by the study sponsor or research team.

Jenske Vermeulen, MSc.

CONTACT

[email protected]

0880057282

Michel Reijnen, MD, prof

CONTACT

[email protected]

0880057282

Sponsors and collaborators

Lead sponsor

Rijnstate Hospital

Other

Collaborators

  • Canisius-Wilhelmina Hospital
  • Deventer Ziekenhuis
  • Gelderse Vallei Hospital
  • Gelre Hospitals
  • Maxima Medical Center
  • Medisch Spectrum Twente
  • Radboud University Medical Center

Registry information

Official study 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)

Acronym: One-Two-Treat

Important dates

Study start
2020
Primary completion
2026
Study completion
2027
First posted
Dec 3, 2019
Registry last updated
Mar 6, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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