Cardiovascular DiseasesVBANCT03493074
Non-invasive Monitoring of Endovascular Repair of Abdominal Aortic Aneurysm (VBA)
An observational study of Cardiovascular Diseases and Abdominal Aortic Aneurysm, run by Tampere University Hospital at 1 site in Finland.
Trial 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 Read more about this study
- Who is it for?
- Ages 18 to 120 years
- Conditions the study is for
- Cardiovascular Diseases, Abdominal Aortic Aneurysm
- What is being tested?
- Noninvasive pulse wave analysis sensor, ECG-sensor
- How many people
- 30 participants
- Where
- 1 siteFinland
- Study dates
- 8 Apr 2018to 30 Aug 2021
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 120 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Finnish, Caucasian
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
Finland1 site, 1 recruiting
- Recruiting
Tampere University Hospital
Tampere, FI-33014
Niku Oksala, Professor, 31164844 ext. +358, niku.oksala@professori.fi
Niku KJ Oksala, Professor
About this study
Official title: Non-invasive Peri- and Postoperative Monitoring of Endovascular Repair of Abdominal Aortic Aneurysm
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
Read the 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.
- Conditions
- Cardiovascular Diseases, Abdominal Aortic Aneurysm
- Being tested
- Noninvasive pulse wave analysis sensor, ECG-sensor
- Medical subject headings
- Cardiovascular Diseases, Aortic Aneurysm, Abdominal
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Noninvasive pulse wave analysis sensor, ECG-sensorDiagnostic test
The sensors are noninvasively attached
What is being measured
The primary outcome is the main question the study is designed to answer.
Pulse wave change from baseline during EVAR measured by a force sensor
A force sensor node for dynamic pressure-PW measurements is utilized to detect pulse wave
Measured: 2 hours
Pulse wave change from baseline during EVAR measured by a optical photoplethysmographic (PPG) sensor
Optical photoplethysmographic (PPG) sensor node is used for volume pulse measurements
Measured: 2 hours
Secondary outcomes (4)
Pulse wave change from baseline after EVAR measured by a force sensor
A force sensor node for dynamic pressure-PW measurements is utilized to detect pulse wave
Measured: 30 days
Pulse wave change from baseline after EVAR measured by a optical photoplethysmographic (PPG) sensor
Optical photoplethysmographic (PPG) sensor node is used for volume pulse measurements
Measured: 30 days
Pulse wave change from baseline after EVAR measured by a force sensor
A force sensor node for dynamic pressure-PW measurements is utilized to detect pulse wave
Measured: 12 months
Pulse wave change from baseline after EVAR measured by a optical
Optical photoplethysmographic (PPG) sensor node is used for volume pulse measurements
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Apr 2018
- Study start8 Apr 2018
- Primary completion30 Aug 2021 (estimated)
- Study completion30 Aug 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cardiovascular DiseasesStudies of the same condition, open and under way.
- More trials run by Tampere University HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Tampere University Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Tampere University of Technology, Tampere University
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03493074
- Sponsor's protocol ID
- R17129
- Acronym
- VBA
- Status last verified
- Oct 2020
- First submitted
- 20 Mar 2018
- Last updated
- 9 Oct 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 9 Oct 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Non-invasive Peri- and Postoperative Monitoring of Endovascular Repair of Abdominal Aortic Aneurysm
- ClinicalTrials.gov ID
- NCT03493074
- Acronym / sponsor ID
- VBA / R17129
- Conditions
- Cardiovascular Diseases, Abdominal Aortic Aneurysm
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Tampere University HospitalUniversity, hospital or other
- Collaborators
- Tampere University of Technology, Tampere University
- Study start
- 8 Apr 2018 (actual)
- Primary completion
- 30 Aug 2021 (estimated)
- Study completion
- 30 Aug 2021 (estimated)
- First posted
- 10 Apr 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 to 120 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Finnish, Caucasian
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (7 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Noninvasive pulse wave analysis sensor, ECG-sensorThe sensors are noninvasively attached | Diagnostic test | – |
Primary outcome
Pulse wave change from baseline during EVAR measured by a force sensor
Time frame: 2 hours
A force sensor node for dynamic pressure-PW measurements is utilized to detect pulse wave
Pulse wave change from baseline during EVAR measured by a optical photoplethysmographic (PPG) sensor
Time frame: 2 hours
Optical photoplethysmographic (PPG) sensor node is used for volume pulse measurements
4 secondary outcomes
Pulse wave change from baseline after EVAR measured by a force sensor
Time frame: 30 days
Pulse wave change from baseline after EVAR measured by a optical photoplethysmographic (PPG) sensor
Time frame: 30 days
Pulse wave change from baseline after EVAR measured by a force sensor
Time frame: 12 months
Pulse wave change from baseline after EVAR measured by a optical
Time frame: 12 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Oct 2020.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Cardiovascular Diseases and Abdominal Aortic Aneurysm, run by Tampere University Hospital at 1 site in Finland.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 9 Oct 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Finland. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Niku Oksala, Professor (400591911, niku.oksala@professori.fi), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Pulse wave change from baseline during EVAR measured by a force sensor (time frame: 2 hours). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Oct 2020.