- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04183426
Tonometry(1) and Duplex Ultrasound(2) to Predict CV Events in to be Treated Patients With an AAA (One-Two-Treat)
Tonometry(1) and Duplex Ultrasound(2) to Predict Cardiovascular Events in to be Treated Patients With an Abdominal Aortic Aneurysm (One-Two-Treat Trial)
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.
Study Overview
Status
Conditions
Intervention / Treatment
Detailed 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.
Study Type
Enrollment (Estimated)
Contacts and Locations
Study Contact
- Name: Michel Reijnen, MD, prof
- Phone Number: 0880057282
- Email: MReijnen@rijnstate.nl
Study Contact Backup
- Name: Jenske Vermeulen, MSc.
- Phone Number: 0880057282
- Email: JVermeulen@rijnstate.nl
Study Locations
-
-
-
Apeldoorn, Netherlands
- Recruiting
- Gelre Hospitals
-
Contact:
- Hessel Buscher
- Email: h.buscher@gelre.nl
-
Contact:
- Franka de Valk
- Email: Franka.de.Valk@gelre.nl
-
Deventer, Netherlands
- Recruiting
- Deventer Hospital
-
Contact:
- Lieuwe van der Hem
- Email: L.vanderHem@dz.nl
-
Ede, Netherlands
- Recruiting
- Ziekenhuis Gelderse Vallei
-
Contact:
- Hans Sybrandy
- Email: SybrandyH@zgv.nl
-
Enschede, Netherlands
- Recruiting
- Medisch Spectrum Twente
-
Contact:
- Theo Menting
- Email: Theo.Menting@mst.nl
-
Contact:
- Anja Stam
- Email: Researchbureau.Heelkunde@mst.nl
-
Veldhoven, Netherlands
- Recruiting
- Maxima Medical Center
-
Contact:
- Maarten Loos
- Email: Maarten.Loos@mmc.nl
-
Contact:
- Margot Heijmans
- Email: Margot.Heijmans@mmc.nl
-
-
Gelderland
-
Nijmegen, Gelderland, Netherlands, 6525GA
- Recruiting
- Radboudumc
-
Contact:
- Dick Thijssen, Prof
- Phone Number: +31 (0)24-361 42 09
- Email: Dick.Thijssen@radboudumc.nl
-
Contact:
- Jenske Vermeulen, MSc.
- Phone Number: +31 (0)24-361 42 09
- Email: Jenske.Vermeulen@radboudumc.nl
-
Nijmegen, Gelderland, Netherlands, 6532SZ
- Recruiting
- Canisius Wilhelmina Ziekenhuis
-
Contact:
- Bianca Bendermacher, MD
- Email: B.Bendermacher@cwz.nl
-
Contact:
- Manon Bindels
- Email: M.Bindels@cwz.nl
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Sampling Method
Study Population
Description
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 Plan
How is the study designed?
Design Details
- Observational Models: Cohort
- Time Perspectives: Prospective
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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
|
2-year follow-up
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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
|
Baseline
|
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
|
Baseline and 6-weeks after operation
|
CAR-test results
Time Frame: Baseline and 6-weeks after operation
|
Magnitude of the blood flow and perfusion response
|
Baseline and 6-weeks after operation
|
CAR-test results
Time Frame: Baseline and 6-weeks after operation
|
Timing of the blood flow and perfusion response
|
Baseline and 6-weeks after operation
|
CAR-test results
Time Frame: Baseline and 6-weeks after operation
|
Blood pressure responses
|
Baseline and 6-weeks after operation
|
CAR-test results
Time Frame: Baseline and 6-weeks after operation
|
Heart rate responses
|
Baseline and 6-weeks after operation
|
CAR-test results
Time Frame: Baseline and 6-weeks after operation
|
Changes after treatment
|
Baseline and 6-weeks after operation
|
SphygmoCor parameters
Time Frame: Baseline, 6-weeks, 1 year and 2 year after operation
|
Peripheral pressure measurements (PWA)
|
Baseline, 6-weeks, 1 year and 2 year after operation
|
SphygmoCor parameters
Time Frame: Baseline, 6-weeks, 1 year and 2 year after operation
|
Central pressure measurements (derived using a transfer function, PWA)
|
Baseline, 6-weeks, 1 year and 2 year after operation
|
SphygmoCor parameters
Time Frame: Baseline, 6-weeks, 1 year and 2 year after operation
|
Abdominal pressure measurements (derived using a transfer function, PWA)
|
Baseline, 6-weeks, 1 year and 2 year after operation
|
SphygmoCor parameters
Time Frame: Baseline, 6-weeks, 1 year and 2 year after operation
|
SEVR
|
Baseline, 6-weeks, 1 year and 2 year after operation
|
SphygmoCor parameters
Time Frame: Baseline, 6-weeks, 1 year and 2 year after operation
|
ED
|
Baseline, 6-weeks, 1 year and 2 year after operation
|
SphygmoCor parameters
Time Frame: Baseline, 6-weeks, 1 year and 2 year after operation
|
PWV
|
Baseline, 6-weeks, 1 year and 2 year after operation
|
SphygmoCor parameters
Time Frame: Baseline and 6-weeks after operation
|
Change in Peripheral pressure measurements (PWA) after treatment
|
Baseline and 6-weeks after operation
|
SphygmoCor parameters
Time Frame: Baseline and 6-weeks after operation
|
Change in Central pressure measurements (derived using a transfer function, PWA) after treatment
|
Baseline and 6-weeks after operation
|
SphygmoCor parameters
Time Frame: Baseline and 6-weeks after operation
|
Change in Abdominal pressure measurements (derived using a transfer function, PWA) after treatment
|
Baseline and 6-weeks after operation
|
SphygmoCor parameters
Time Frame: Baseline and 6-weeks after operation
|
Change in SEVR after treatment
|
Baseline and 6-weeks after operation
|
SphygmoCor parameters
Time Frame: Baseline and 6-weeks after operation
|
Change in ED after treatment
|
Baseline and 6-weeks after operation
|
SphygmoCor parameters
Time Frame: Baseline and 6-weeks after operation
|
Change in PWV after treatment
|
Baseline and 6-weeks after operation
|
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
|
Baseline, 6-weeks, 1 year and 2 year after operation
|
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
|
Baseline, 6-weeks, 1 year and 2 year after operation
|
Other Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Demographic characteristics
Time Frame: Baseline
|
Age
|
Baseline
|
Demographic characteristics
Time Frame: Baseline
|
Gender
|
Baseline
|
Demographic characteristics
Time Frame: Baseline
|
If current smoker
|
Baseline
|
Demographic characteristics
Time Frame: Baseline
|
Height
|
Baseline
|
Demographic characteristics
Time Frame: Baseline
|
Weight
|
Baseline
|
Demographic characteristics
Time Frame: Baseline
|
ASA class
|
Baseline
|
Demographic characteristics
Time Frame: Baseline
|
Medical history
|
Baseline
|
Demographic characteristics
Time Frame: Baseline
|
Blood pressure
|
Baseline
|
Demographic characteristics
Time Frame: Baseline
|
Heart rate
|
Baseline
|
Demographic characteristics
Time Frame: Baseline
|
Cardiac measurements
|
Baseline
|
Demographic characteristics
Time Frame: Baseline
|
SVS class
|
Baseline
|
Preoperative anatomic characteristics before primary repair procedure
Time Frame: Baseline
|
AAA sac diameter
|
Baseline
|
Preoperative anatomic characteristics before primary repair procedure
Time Frame: Baseline
|
Infrarenal aortic neck lumen diameter
|
Baseline
|
Preoperative anatomic characteristics before primary repair procedure
Time Frame: Baseline
|
Proximal non-aneurysmal aortic neck length
|
Baseline
|
Preoperative anatomic characteristics before primary repair procedure
Time Frame: Baseline
|
Proximal aortic neck angle
|
Baseline
|
Preoperative anatomic characteristics before primary repair procedure
Time Frame: Baseline
|
Aneurysm blood lumen diameter
|
Baseline
|
Preoperative anatomic characteristics before primary repair procedure
Time Frame: Baseline
|
Common iliac artery diameters
|
Baseline
|
Preoperative anatomic characteristics before primary repair procedure
Time Frame: Baseline
|
Blood lumen diameter
|
Baseline
|
Procedure and discharge details of intervention
Time Frame: At time of procedure
|
Type of procedure
|
At time of procedure
|
Procedure and discharge details of intervention
Time Frame: At time of procedure
|
Anesthesia type
|
At time of procedure
|
Procedure and discharge details of intervention
Time Frame: At time of procedure
|
Access type
|
At time of procedure
|
Procedure and discharge details of intervention
Time Frame: At time of procedure
|
Used stent lengths
|
At time of procedure
|
Procedure and discharge details of intervention
Time Frame: At time of procedure
|
Contrast volume used
|
At time of procedure
|
Procedure and discharge details of intervention
Time Frame: At time of procedure
|
Total procedure time
|
At time of procedure
|
Procedure and discharge details of intervention
Time Frame: At time of procedure
|
Immediate procedural technical success
|
At time of procedure
|
Procedure and discharge details of intervention
Time Frame: During procedure
|
Complications pre procedure
|
During procedure
|
Procedure and discharge details of intervention
Time Frame: Up to 2 years
|
Complications post procedure
|
Up to 2 years
|
Procedure and discharge details of intervention
Time Frame: During procedure
|
Additional procedures estimated blood loss
|
During procedure
|
Procedure and discharge details of intervention
Time Frame: During procedure
|
Blood transfusion
|
During procedure
|
Procedure and discharge details of intervention
Time Frame: Up to 2 years
|
Concomitant procedures
|
Up to 2 years
|
Procedure and discharge details of intervention
Time Frame: After procedure till discharge
|
Time in ICU
|
After procedure till discharge
|
Procedure and discharge details of intervention
Time Frame: After procedure till discharge
|
Time to hospital discharge
|
After procedure till discharge
|
Medications
Time Frame: During 2-year follow up
|
Dose of Anti-platelets
|
During 2-year follow up
|
Medications
Time Frame: During 2-year follow up
|
Dose of Anti-coagulants
|
During 2-year follow up
|
Medications
Time Frame: During 2-year follow up
|
Dose of Anti-hypertensives
|
During 2-year follow up
|
Medications
Time Frame: During 2-year follow up
|
Dose of Statins
|
During 2-year follow up
|
Medications
Time Frame: During 2-year follow up
|
Dose of Beta-blockers
|
During 2-year follow up
|
Medications
Time Frame: During 2-year follow up
|
Dose of Sympathicomimetics
|
During 2-year follow up
|
Laboratory test results
Time Frame: 2-year follow-up
|
Hemoglobin
|
2-year follow-up
|
Laboratory test results
Time Frame: 2-year follow-up
|
Serum creatinine
|
2-year follow-up
|
Laboratory test results
Time Frame: 2-year follow-up
|
Cholesterol
|
2-year follow-up
|
Laboratory test results
Time Frame: 2-year follow-up
|
eGFR
|
2-year follow-up
|
Laboratory test results
Time Frame: 2-year follow-up
|
CRP
|
2-year follow-up
|
Parameters during follow-up
Time Frame: 2-year follow-up
|
Any type of endoleak
|
2-year follow-up
|
Parameters during follow-up
Time Frame: 2-year follow-up
|
AAA sac expansion
|
2-year follow-up
|
Parameters during follow-up
Time Frame: 2-year follow-up
|
Any other (S)AE
|
2-year follow-up
|
Collaborators and Investigators
Sponsor
Collaborators
Investigators
- Principal Investigator: Michel Reijnen, MD, prof, Rijnstate Hospital
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Estimated)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- One-Two-Treat Trial
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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