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

Abdominal Aortic Aneurysm Clinical Trial

— One-Two-Treat  

Official 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)

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04183426
• Other study ID #: One-Two-Treat Trial
• Status: Recruiting
• Start date: June 12, 2020
• Est. completion date: June 2027

Study information

• Verified date: November 2023
• Source: Rijnstate Hospital
• Contact: Michel Reijnen, MD, prof
• Phone: 0880057282
• Email: MReijnen[@]rijnstate.nl
• 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, 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 194
• Est. completion date: June 2027
• Est. primary completion date: December 2026
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years 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 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.

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 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
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.

Locations

Country	Name	City	State
Netherlands	Gelre Hospitals	Apeldoorn
Netherlands	Deventer Hospital	Deventer
Netherlands	Ziekenhuis Gelderse Vallei	Ede
Netherlands	Medisch Spectrum Twente	Enschede
Netherlands	Canisius Wilhelmina Ziekenhuis	Nijmegen	Gelderland
Netherlands	Radboudumc	Nijmegen	Gelderland
Netherlands	Maxima Medical Center	Veldhoven

Sponsors (8)

Lead Sponsor	Collaborator
Rijnstate Hospital	Canisius-Wilhelmina Hospital, Deventer Ziekenhuis, Gelderse Vallei Hospital, Gelre Hospitals, Maxima Medical Center, Medisch Spectrum Twente, Radboud University Medical Center

Country where clinical trial is conducted

Netherlands, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Demographic characteristics	Age	Baseline
Other	Demographic characteristics	Gender	Baseline
Other	Demographic characteristics	If current smoker	Baseline
Other	Demographic characteristics	Height	Baseline
Other	Demographic characteristics	Weight	Baseline
Other	Demographic characteristics	ASA class	Baseline
Other	Demographic characteristics	Medical history	Baseline
Other	Demographic characteristics	Blood pressure	Baseline
Other	Demographic characteristics	Heart rate	Baseline
Other	Demographic characteristics	Cardiac measurements	Baseline
Other	Demographic characteristics	SVS class	Baseline
Other	Preoperative anatomic characteristics before primary repair procedure	AAA sac diameter	Baseline
Other	Preoperative anatomic characteristics before primary repair procedure	Infrarenal aortic neck lumen diameter	Baseline
Other	Preoperative anatomic characteristics before primary repair procedure	Proximal non-aneurysmal aortic neck length	Baseline
Other	Preoperative anatomic characteristics before primary repair procedure	Proximal aortic neck angle	Baseline
Other	Preoperative anatomic characteristics before primary repair procedure	Aneurysm blood lumen diameter	Baseline
Other	Preoperative anatomic characteristics before primary repair procedure	Common iliac artery diameters	Baseline
Other	Preoperative anatomic characteristics before primary repair procedure	Blood lumen diameter	Baseline
Other	Procedure and discharge details of intervention	Type of procedure	At time of procedure
Other	Procedure and discharge details of intervention	Anesthesia type	At time of procedure
Other	Procedure and discharge details of intervention	Access type	At time of procedure
Other	Procedure and discharge details of intervention	Used stent lengths	At time of procedure
Other	Procedure and discharge details of intervention	Contrast volume used	At time of procedure
Other	Procedure and discharge details of intervention	Total procedure time	At time of procedure
Other	Procedure and discharge details of intervention	Immediate procedural technical success	At time of procedure
Other	Procedure and discharge details of intervention	Complications pre procedure	During procedure
Other	Procedure and discharge details of intervention	Complications post procedure	Up to 2 years
Other	Procedure and discharge details of intervention	Additional procedures estimated blood loss	During procedure
Other	Procedure and discharge details of intervention	Blood transfusion	During procedure
Other	Procedure and discharge details of intervention	Concomitant procedures	Up to 2 years
Other	Procedure and discharge details of intervention	Time in ICU	After procedure till discharge
Other	Procedure and discharge details of intervention	Time to hospital discharge	After procedure till discharge
Other	Medications	Dose of Anti-platelets	During 2-year follow up
Other	Medications	Dose of Anti-coagulants	During 2-year follow up
Other	Medications	Dose of Anti-hypertensives	During 2-year follow up
Other	Medications	Dose of Statins	During 2-year follow up
Other	Medications	Dose of Beta-blockers	During 2-year follow up
Other	Medications	Dose of Sympathicomimetics	During 2-year follow up
Other	Laboratory test results	Hemoglobin	2-year follow-up
Other	Laboratory test results	Serum creatinine	2-year follow-up
Other	Laboratory test results	Cholesterol	2-year follow-up
Other	Laboratory test results	eGFR	2-year follow-up
Other	Laboratory test results	CRP	2-year follow-up
Other	Parameters during follow-up	Any type of endoleak	2-year follow-up
Other	Parameters during follow-up	AAA sac expansion	2-year follow-up
Other	Parameters during follow-up	Any other (S)AE	2-year follow-up
Primary	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	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	CAR-test results	Percentage of vasodilation/vasoconstriction to the CAR test at the common carotid artery at baseline	Baseline and 6-weeks after operation
Secondary	CAR-test results	Magnitude of the blood flow and perfusion response	Baseline and 6-weeks after operation
Secondary	CAR-test results	Timing of the blood flow and perfusion response	Baseline and 6-weeks after operation
Secondary	CAR-test results	Blood pressure responses	Baseline and 6-weeks after operation
Secondary	CAR-test results	Heart rate responses	Baseline and 6-weeks after operation
Secondary	CAR-test results	Changes after treatment	Baseline and 6-weeks after operation
Secondary	SphygmoCor parameters	Peripheral pressure measurements (PWA)	Baseline, 6-weeks, 1 year and 2 year after operation
Secondary	SphygmoCor parameters	Central pressure measurements (derived using a transfer function, PWA)	Baseline, 6-weeks, 1 year and 2 year after operation
Secondary	SphygmoCor parameters	Abdominal pressure measurements (derived using a transfer function, PWA)	Baseline, 6-weeks, 1 year and 2 year after operation
Secondary	SphygmoCor parameters	SEVR	Baseline, 6-weeks, 1 year and 2 year after operation
Secondary	SphygmoCor parameters	ED	Baseline, 6-weeks, 1 year and 2 year after operation
Secondary	SphygmoCor parameters	PWV	Baseline, 6-weeks, 1 year and 2 year after operation
Secondary	SphygmoCor parameters	Change in Peripheral pressure measurements (PWA) after treatment	Baseline and 6-weeks after operation
Secondary	SphygmoCor parameters	Change in Central pressure measurements (derived using a transfer function, PWA) after treatment	Baseline and 6-weeks after operation
Secondary	SphygmoCor parameters	Change in Abdominal pressure measurements (derived using a transfer function, PWA) after treatment	Baseline and 6-weeks after operation
Secondary	SphygmoCor parameters	Change in SEVR after treatment	Baseline and 6-weeks after operation
Secondary	SphygmoCor parameters	Change in ED after treatment	Baseline and 6-weeks after operation
Secondary	SphygmoCor parameters	Change in PWV after treatment	Baseline and 6-weeks after operation
Secondary	Score EQ-5D questionnaire	Patient reported outcomes measured by the general health questionnaire	Baseline, 6-weeks, 1 year and 2 year after operation
Secondary	Score IPQ-K questionnaire	Patient reported outcomes measured by the disease perception questionnaire	Baseline, 6-weeks, 1 year and 2 year after operation