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

NCT04183426 | Recruiting

• 1 other identifier: One-Two-Treat Trial
• Study Type: observational
• Target: 194
• Locations: 1 country
• Sites: 7

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.

Conditions

Abdominal Aortic Aneurysm; Cardiovascular Events

Keywords

Functional Response; Abdominal Aortic Aneurysm; Cardiovascular Events

Outcome Measures

Primary Outcomes (1)

• Major Adverse Cardiovascular Events (MACE)

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

  2-year follow-up

Secondary Outcomes (21)

• SMART Risk score

  Baseline

• CAR-test results

  Baseline and 6-weeks after operation

• CAR-test results

  Baseline and 6-weeks after operation

• CAR-test results

  Baseline and 6-weeks after operation

• CAR-test results

  Baseline and 6-weeks after operation

Other Outcomes (46)

• Demographic characteristics

  Baseline

• Demographic characteristics

  Baseline

• Demographic characteristics

  Baseline

Interventions

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.

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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;

You may not qualify if:

• 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.

Sponsors & Collaborators

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

Study Sites (7)

Radboudumc

Nijmegen, Gelderland, 6525GA, Netherlands

RECRUITING

Canisius Wilhelmina Ziekenhuis

Nijmegen, Gelderland, 6532SZ, Netherlands

RECRUITING

Gelre Hospitals

Apeldoorn, Netherlands

RECRUITING

Deventer Hospital

Deventer, Netherlands

RECRUITING

Ziekenhuis Gelderse Vallei

Ede, Netherlands

RECRUITING

Medisch Spectrum Twente

Enschede, Netherlands

RECRUITING

Maxima Medical Center

Veldhoven, Netherlands

RECRUITING

MeSH Terms

Conditions

Aortic Aneurysm, Abdominal

Interventions

Vascular Stiffness

Condition Hierarchy (Ancestors)

Aortic Aneurysm; Aneurysm; Vascular Diseases; Cardiovascular Diseases; Aortic Diseases

Intervention Hierarchy (Ancestors)

Cardiovascular Physiological Phenomena; Circulatory and Respiratory Physiological Phenomena

Study Officials

• Michel Reijnen, MD, prof

  Rijnstate Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Michel Reijnen, MD, prof

CONTACT

0880057282; MReijnen@rijnstate.nl

Jenske Vermeulen, MSc.

CONTACT

0880057282; JVermeulen@rijnstate.nl

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 19, 2019
• First Posted: December 3, 2019
• Study Start: June 12, 2020
• Primary Completion (Estimated): December 1, 2026
• Study Completion (Estimated): June 1, 2027
• Last Updated: March 6, 2025

Record last verified: 2025-03

Locations

NL (7)