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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT04183426
Other study ID # One-Two-Treat Trial
Secondary ID
Status Recruiting
Phase
First received
Last updated
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
Health authority
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.

Study Design


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
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