Aortic Aneurysm, AbdominalNCT02642952
Impact of Grafts and Endografts for Abdominal Aneurysms on Arterial Stiffness.
An observational study of Aortic Aneurysm, Abdominal, run by Hospital Universitario Ramon y Cajal at 1 site in Spain.
Trial summary
The purpose of this study is to evaluate by non-invasive methods the change in central hemodynamics and arterial stiffness produced by grafts and endografts after abdominal aortic aneurysm repair. Read more about this study
- Who is it for?
- Ages 50 to 90 years
- Conditions the study is for
- Aortic Aneurysm, Abdominal
- What is being tested?
- non-invasive methods
- How many people
- 52 participants
- Where
- 1 siteSpain
- Study dates
- Jan 2016to Feb 2017
- Phase
- Observational
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 50 to 90 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients consecutive treated for abdominal aortic aneurysm. The election of treatment is selected based on morphology and health status.
Who may be able to join
- Patients with diagnosis of abdominal aortic aneurysm requiring repair (open or endovascular) based on guidelines criteria for management.
Who cannot join
- Patients who don´t want to enter in the study.
- Patients who don´t want to sign the informed consent.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Impact of Aortic Grafts After Open and Endovascular Repair in Central Hemodynamics and Arterial Stiffness Measured by Non-invasive Methods in Patients With Abdominal Aortic Aneurysms.
The purpose of this study is to evaluate by non-invasive methods the change in central hemodynamics and arterial stiffness produced by grafts and endografts after abdominal aortic aneurysm repair.
Our main goal is to measure the changes in:
Augmentation index, central blood pressure, pulse wave analysis, pulse wave velocity.
Read the detailed description
The measures will be done before the procedure and after them.
We will use the device called: SphygmocoR (Atcor Medical, Sydney, Australia).
- Conditions
- Aortic Aneurysm, Abdominal
- Being tested
- non-invasive methods
- Keywords
- arterial stiffness, central hemodynamics
- Medical subject headings
- Aortic Aneurysm, Abdominal
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
non-invasive methodsOther
To measure central hemodynamics and arterial stiffness by non-invasive methods using SphygmocoR (Atcor Medical, Sydney, Australia) before and after the procedure.
| Study group | Role | What they receive |
|---|---|---|
| Open-graft group | Patients treated for abdominal aortic aneurysm with open graft will be measured for central hemodynamics and arterial stiffness by non-invasive methods. Receives: Other: non-invasive methods | |
| Endograft group | Patients treated for abdominal aortic aneurysm with endograft will be measured for central hemodynamics and arterial stiffness by non-invasive methods. Receives: Other: non-invasive methods |
What is being measured
The primary outcome is the main question the study is designed to answer.
Aix@75
Augmentation Index corrected to 75 bpm
Measured: Before surgery
AIx@75
Augmentation Index corrected to 75 bpm
Measured: 2 months after Surgery
Secondary outcomes (3)
Central Blood Pressure
Measured: before surgery
Carotid Radial Pulse Wave Velocity
Measured: before surgery
Carotid Radial Pulse Wave Velocity
Measured: 2 months after surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Dec 2015 (estimated)
- Study startJan 2016
- Primary completionJan 2017
- Study completionFeb 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for Aortic Aneurysm, AbdominalStudies of the same condition, open and under way.
- 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
- Cohort
- Time perspective
- Prospective
- Enrolment
- 52 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hospital Universitario Ramon y Cajal
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Andrés Reyes Valdivia, Hospital Universitario Ramon y Cajal
- Investigators
- Andrés Reyes, Consultant, Principal investigator, Hospital Universitario Ramon y Cajal
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02642952
- Sponsor's protocol ID
- IMPACT001
- Status last verified
- Aug 2018
- First submitted
- 28 Dec 2015
- Last updated
- 30 Jan 2019
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- Individual data sharing
- Undecided
Publications
Paraskevas KI, Bessias N, Psathas C, Akridas K, Dragios T, Nikitas G, Andrikopoulos V, Mikhailidis DP, Kyriakides ZS. Evaluation of aortic stiffness (aortic pulse-wave velocity) before and after elective abdominal aortic aneurysm repair procedures: a pilot study. Open Cardiovasc Med J. 2009 Dec 9;3:173-5. doi: 10.2174/1874192400903010173.
PubMed 20054420Kadoglou NP, Moulakakis KG, Papadakis I, Ikonomidis I, Alepaki M, Lekakis J, Liapis CD. Changes in aortic pulse wave velocity of patients undergoing endovascular repair of abdominal aortic aneurysms. J Endovasc Ther. 2012 Oct;19(5):661-6. doi: 10.1583/JEVT-12-3916MR.1.
PubMed 23046333Kadoglou NP, Moulakakis KG, Papadakis I, Ikonomidis I, Alepaki M, Spathis A, Karakitsos P, Lekakis J, Liapis CD. Differential effects of stent-graft fabrics on arterial stiffness in patients undergoing endovascular aneurysm repair. J Endovasc Ther. 2014 Dec;21(6):850-8. doi: 10.1583/14-4772MR.1.
PubMed 25453890Lantelme P, Dzudie A, Milon H, Bricca G, Legedz L, Chevalier JM, Feugier P. Effect of abdominal aortic grafts on aortic stiffness and central hemodynamics. J Hypertens. 2009 Jun;27(6):1268-76. doi: 10.1097/HJH.0b013e3283299b22.
PubMed 19342960Valdivia AR, Fuente MF, Santos AD, Urena MG, Lozano AR, Guaita JO, Zuniga CG, Donas K, Ruiz JS. Impact of the Aortic Graft on Arterial Stiffness and Inflammatory Biomarkers after Endovascular Aortic Repair or Open Surgical Repair in Abdominal Aortic Aneurysm Disease. Ann Vasc Surg. 2019 Aug;59:84-90. doi: 10.1016/j.avsg.2018.12.092. Epub 2019 Feb 23.
PubMed 30802592
Study at a glance
From the registry record, last updated by the sponsor on 30 Jan 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Impact of Aortic Grafts After Open and Endovascular Repair in Central Hemodynamics and Arterial Stiffness Measured by Non-invasive Methods in Patients With Abdominal Aortic Aneurysms.
- ClinicalTrials.gov ID
- NCT02642952
- Acronym / sponsor ID
- IMPACT001
- Conditions
- Aortic Aneurysm, Abdominal
- Keywords
- arterial stiffness, central hemodynamics
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 52 participants (actual)
- Lead sponsor
- Hospital Universitario Ramon y CajalUniversity, hospital or other
- Study start
- Jan 2016
- Primary completion
- Jan 2017 (actual)
- Study completion
- Feb 2017 (actual)
- First posted
- 30 Dec 2015 (estimated)
- Results
- Posted 30 Jan 2019
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study is to evaluate by non-invasive methods the change in central hemodynamics and arterial stiffness produced by grafts and endografts after abdominal aortic aneurysm repair.
Our main goal is to measure the changes in:
Augmentation index, central blood pressure, pulse wave analysis, pulse wave velocity.
Detailed description
The measures will be done before the procedure and after them.
We will use the device called: SphygmocoR (Atcor Medical, Sydney, Australia).
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Open-graft group | – | Other: non-invasive methodsPatients treated for abdominal aortic aneurysm with open graft will be measured for central hemodynamics and arterial stiffness by non-invasive methods. |
| Endograft group | – | Other: non-invasive methodsPatients treated for abdominal aortic aneurysm with endograft will be measured for central hemodynamics and arterial stiffness by non-invasive methods. |
Who may qualify
- Ages
- 50 to 90 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients consecutive treated for abdominal aortic aneurysm. The election of treatment is selected based on morphology and health status.
Key inclusion criteria (1 listed)
- Patients with diagnosis of abdominal aortic aneurysm requiring repair (open or endovascular) based on guidelines criteria for management.
Key exclusion criteria (2 listed)
- Patients who don´t want to enter in the study.
- Patients who don´t want to sign the informed consent.
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 |
|---|---|---|
| non-invasive methodsTo measure central hemodynamics and arterial stiffness by non-invasive methods using SphygmocoR (Atcor Medical, Sydney, Australia) before and after the procedure. | Other | Endograft group, Open-graft group |
Primary outcome
Aix@75
Time frame: Before surgery
Augmentation Index corrected to 75 bpm
AIx@75
Time frame: 2 months after Surgery
Augmentation Index corrected to 75 bpm
3 secondary outcomes
Central Blood Pressure
Time frame: before surgery
Carotid Radial Pulse Wave Velocity
Time frame: before surgery
Carotid Radial Pulse Wave Velocity
Time frame: 2 months after surgery
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Jan 2019.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Background: PubMed 20054420Paraskevas KI, Bessias N, Psathas C, Akridas K, Dragios T, Nikitas G, Andrikopoulos V, Mikhailidis DP, Kyriakides ZS. Evaluation of aortic stiffness (aortic pulse-wave velocity) before and after elective abdominal aortic aneurysm repair procedures: a pilot study. Open Cardiovasc Med J. 2009 Dec 9;3:173-5. doi: 10.2174/1874192400903010173.
- Background: PubMed 23046333Kadoglou NP, Moulakakis KG, Papadakis I, Ikonomidis I, Alepaki M, Lekakis J, Liapis CD. Changes in aortic pulse wave velocity of patients undergoing endovascular repair of abdominal aortic aneurysms. J Endovasc Ther. 2012 Oct;19(5):661-6. doi: 10.1583/JEVT-12-3916MR.1.
- Background: PubMed 25453890Kadoglou NP, Moulakakis KG, Papadakis I, Ikonomidis I, Alepaki M, Spathis A, Karakitsos P, Lekakis J, Liapis CD. Differential effects of stent-graft fabrics on arterial stiffness in patients undergoing endovascular aneurysm repair. J Endovasc Ther. 2014 Dec;21(6):850-8. doi: 10.1583/14-4772MR.1.
- Background: PubMed 19342960Lantelme P, Dzudie A, Milon H, Bricca G, Legedz L, Chevalier JM, Feugier P. Effect of abdominal aortic grafts on aortic stiffness and central hemodynamics. J Hypertens. 2009 Jun;27(6):1268-76. doi: 10.1097/HJH.0b013e3283299b22.
- Derived from this study: PubMed 30802592Valdivia AR, Fuente MF, Santos AD, Urena MG, Lozano AR, Guaita JO, Zuniga CG, Donas K, Ruiz JS. Impact of the Aortic Graft on Arterial Stiffness and Inflammatory Biomarkers after Endovascular Aortic Repair or Open Surgical Repair in Abdominal Aortic Aneurysm Disease. Ann Vasc Surg. 2019 Aug;59:84-90. doi: 10.1016/j.avsg.2018.12.092. Epub 2019 Feb 23.
- 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.
Andrés Reyes, Consultant principal investigator
Hospital Universitario Ramon y Cajal
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 Aortic Aneurysm, Abdominal, run by Hospital Universitario Ramon y Cajal at 1 site in Spain.
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 1 inclusion and 2 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: finished, as of the sponsor's last update on 30 Jan 2019. 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 Spain. 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?
Yes. Results are posted in the registry (first posted 30 Jan 2019). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Aix@75 (time frame: Before surgery). 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?
On the ClinicalTrials.gov record for NCT02642952, which also lists 5 linked publications.
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 30 Jan 2019.