Tonometry and Duplex Ultrasound to Predict AAA Progression and CV Events in Aneurysm Patients (1-2-3 Trial)

Abdominal Aortic Aneurysm Clinical Trial

Official title:

Tonometry (1) and Duplex Ultrasound (2) to Predict Abdominal Aorta Aneurysm (3) Progression and Cardiovascular Events in Aneurysm Patients

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03989011
• Other study ID #: NL68953.091.19
• Status: Completed
• Start date: July 1, 2019
• Est. completion date: December 1, 2023

Study information

• Verified date: April 2024
• Source: Rijnstate Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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, highlighting the need to explore the potential of novel techniques. Both progression of AAA and CV events are strongly linked to vascular health. In 2013, the SMART risk score is 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 recently 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 in comparison to the SMART risk score for the development of cardiovascular events in patients with an abdominal aortic aneurysm who have not yet reached the treatment threshold. This could aid clinical decision making in the need for (surgical) intervention, but also alter (drug) treatment to reduce risk of cardiovascular events. Secondary objectives are to investigate the predictive capacity of the CAR-test for progression of the abdominal aortic aneurysm, and to evaluate QoL scores in patients under surveillance for AAA. The aim is to provide insight if these scores can help clinical decision making.

Description:

The investigators will include 167 patients under surveillance for AAA who are all currently under the threshold for repair (i.e. AAA diameter 40-50 mm for men and 35-45 mm for women). Participants will be recruited from all collaborating hospitals (Radboudumc, Rijnstate, CWZ) after providing written informed consent. Additionally, 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. In this observational, prospective study, a total of 167 patients under surveillance for an AAA, who are currently under threshold for repair (i.e. AAA diameter 40-50 mm for men and 35-44 mm for women), 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), the investigators will perform the CAR-test (10-min) and non-invasive arterial stiffness measures (PWA and PWV with the SphygmoCor device (10-min) one time as baseline. Furthermore, the investigators will ask patients to complete a questionnaire about the quality of their life (Appendix 1). A second questionnaire tries to clarify the disease experience of the patients and can be found in Appendix 2. Both questionnaires will be asked to be completed at the start and the end of the study. 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 AAA progression (in mm/year) and the ability of the CAR parameter and arterial stiffness parameters to predict CV-events.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 167
• Est. completion date: December 1, 2023
• Est. primary completion date: May 1, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A and older

Eligibility

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 abdominal aortic aneurysm (AAA), who is still under surveillance;

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; this questionnaire can be found in Appendix 3);
• Presence of Raynaud's phenomenon, 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.

Related Conditions & MeSH terms

• Abdominal Aortic Aneurysm
• Aneurysm
• Aortic Aneurysm
• Aortic Aneurysm, Abdominal
• Cardiovascular Events

Intervention

Diagnostic Test:
• Carotid 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 celsius) 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
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 (SEVR, 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.

Locations

Country	Name	City	State
Netherlands	Rijnstate Hospital	Arnhem
Netherlands	Canisius Wilhelmina Ziekenhuis	Nijmegen	Gelderland
Netherlands	Radboudumc	Nijmegen	Gelderland

Sponsors (3)

Lead Sponsor	Collaborator
Rijnstate Hospital	Canisius-Wilhelmina Hospital, Radboud University Medical Center

Country where clinical trial is conducted

Netherlands, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Demographic characteristics	Age	2 year follow up
Other	Demographic characteristics	gender	2 year follow up
Other	Demographic characteristics	height	2 year follow up
Other	Demographic characteristics	weight	2 year follow up
Other	Demographic characteristics	ASA class	2 year follow up
Other	Demographic characteristics	medical history	2 year follow up
Other	Demographic characteristics	blood pressure	2 year follow up
Other	Demographic characteristics	heart rate	2 year follow up
Other	Demographic characteristics	cardiac measurements	2 year follow up
Other	Demographic characteristics	SVS class	2 year follow up
Other	Medication use	Anti-platelets	2 year follow up
Other	Medication use	anti-coagulants	2 year follow up
Other	Medication use	anti-hypertensives	2 year follow up
Other	Medication use	statins	2 year follow up
Other	Medication use	beta-blockers	2 year follow up
Other	Medication use	sympathicomimetics	2 year follow up
Other	Laboratory results	Hemoglobin	2 year follow up
Other	Laboratory results	serum creatinine	2 year follow up
Other	Laboratory results	cholesterol	2 year follow up
Other	Laboratory results	eGFR	2 year follow up
Other	Laboratory results	crp	2 year follow up
Other	Anatomic characteristics of AAA	AAA sac diameter	2 year follow up
Other	Anatomic characteristics of AAA	infrarenal aortic neck lumen diameter	2 year follow up
Other	Anatomic characteristics of AAA	proximal non-aneurysmal aortic neck length	2 year follow up
Other	Anatomic characteristics of AAA	proximal aortic neck angle	2 year follow up
Other	Anatomic characteristics of AAA	aneurysm blood lumen diameter	2 year follow up
Other	Anatomic characteristics of AAA	common iliac artery diameter left	2 year follow up
Other	Anatomic characteristics of AAA	common iliac artery diameter right	2 year follow up
Other	Anatomic characteristics of AAA	blood lumen diameter	2 year follow up
Primary	Major Adverse Cardiovascular Events (MACE)	Incidence of MACE including myocardial infarction, cerebral infarction, heart failure, and peripheral vascular disease	2 year follow-up
Secondary	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	Baseline
Secondary	SphygmoCor parameters	Peripheral pressure measurements (PWA)	Baseline
Secondary	SphygmoCor parameters	central pressure measurements (derived using a transfer function, PWA)	Baseline
Secondary	SphygmoCor parameters	abdominal pressure measurements (derived using a transfer function, PWA)	Baseline
Secondary	SphygmoCor parameters - cardiac output parameter	SEVR	Baseline
Secondary	SphygmoCor parameters - cardiac output parameter	ED	Baseline
Secondary	SphygmoCor parameters	PWV	Baseline
Secondary	CAR-test results	Percentage of vasodilation/vasoconstriction to the CAR test at the common carotid artery at baseline	Baseline
Secondary	CAR-test results	magnitude of the blood flow and perfusion response	Baseline
Secondary	CAR-test results	timing of the blood flow and perfusion response	Baseline
Secondary	CAR-test results	blood pressure responses	Baseline
Secondary	CAR-test results	heart rate responses	Baseline
Secondary	AAA progression	AAA diameter progression in mm/year	2 year follow up
Secondary	Aorta repair	If the patient underwent aorta repair	Within 2 year follow-up
Secondary	AAA rupture	If the AAA ruptured	Within 2 year follow up
Secondary	Score EQ-5D questionnaire	Patient reported outcomes measured by the general health questionnaire	At baseline and after 2 years
Secondary	Score IPQ-K questionnaire	Patient reported outcomes measured by the disease perception questionnaire	At baseline and after 2 years
Secondary	Clinical success	Incidence of serious adverse events	2 year follow up