Clinical trial NCT03493074: Non-invasive Monitoring of Endovascular Repair of Abdominal Aortic Aneurysm (VBA)
Official title: Non-invasive Peri- and Postoperative Monitoring of Endovascular Repair of Abdominal Aortic Aneurysm
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Cardiovascular Diseases
Abdominal Aortic Aneurysm
Lead sponsor: Tampere University Hospital
Sponsor class: OTHER
Collaborators: name: Tampere University of Technology
name: Tampere University
First posted: 2018-04-10
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Maximum age (years): 120
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Finnish, Caucasian

Brief summary: This study evaluates a novel noninvasive method to dynamically monitor the effect of abdominal aortic aneurysm (AAA) and endovascular treatment of AAA (EVAR) on arterial pulse wave

Detailed description: Abdominal aortic aneurysm (AAA) develops slowly and degeneratively (increasing diameter, wall tension, thinning and decreased wall strength, altered compliance) which affects the aortic pressure and wave reflection. In 50% of cases, AAA rupture may lead to death and 50% of the remaining patients referred to hospital die. This results in high costs and preventable loss of lives. AAA can also be detected by pulse wave (PW) analysis. which could enable development of easy to use, affordable and accurate methodology for the detection of AAAs. The measurement system used in the present study is capable of wireless recording of PWs from several different locations utilizing two different sensor modalities (blood-volume related photoplethysmographic (PPG) PWs and dynamic blood pressure PWs). The objective is to study PWs in the detection of AAA and the effects of endovascular repair (EVAR) and whether adverse effects (i.e. endograft failure) can be detected. It is hypothesized that AAA and failure of the operation can be detected by PW features, especially by printed flexible sensors which will improve the usability, patient comfort and safety (hygiene). The technology could make it possible to screen AAAs at lower costs even in the municipal health centers or by the patients themselves, at similar accuracy, without skilled personnel operating the diagnostic devices and therefore improve the cost effectiveness of AAA screening resulting in significant savings, resource reallocation in the healthcare and also improved patient safety and prevention of deaths. It could also enable patient-centered, comfort follow-up for patients treated by EVAR.

Eligibility criteria: Inclusion Criteria:

* The patient has been clinically examined at policlinic of vascular surgery
* The patient has been examined with computed tomography (CT) imaging
* The patient has been considered a candidate for the EVAR of the AAA

Exclusion Criteria:

* A patient has a pacemaker
* A medical doctor decides that the measurement disturbs or risks the subject's treatment process
* Subject's denial (or withdrawal)
* A patient has at least one amputated limb
* The age of the test subject candidate is less than 18 years
* A test subject candidate is not able to understand the study or is not legally competent
* A test subject candidate has Ehlers-Danlos syndrome or Marfan syndrome

Primary outcomes:
measure: Pulse wave change from baseline during EVAR measured by a force sensor
timeFrame: 2 hours
measure: Pulse wave change from baseline during EVAR measured by a optical photoplethysmographic (PPG) sensor
timeFrame: 2 hours
Secondary outcomes:
measure: Pulse wave change from baseline after EVAR measured by a force sensor
timeFrame: 30 days
measure: Pulse wave change from baseline after EVAR measured by a optical photoplethysmographic (PPG) sensor
timeFrame: 30 days
measure: Pulse wave change from baseline after EVAR measured by a force sensor
timeFrame: 12 months
measure: Pulse wave change from baseline after EVAR measured by a optical
timeFrame: 12 months
Other outcomes:
Locations:
city: Tampere
country: Finland
facility: Tampere University Hospital
Study officials:
References: