Impact of Grafts and Endografts for Abdominal Aneurysms on Arterial Stiffness.

NCT ID: NCT02642952

Last Updated: 2019-01-30

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

52 participants

Study Classification

OBSERVATIONAL

Study Start Date

2016-01-31

Study Completion Date

2017-02-28

Brief Summary

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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

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The measures will be done before the procedure and after them.

We will use the device called: SphygmocoR (Atcor Medical, Sydney, Australia).

Conditions

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Aortic Aneurysm, Abdominal

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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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.

non-invasive methods

Intervention Type OTHER

To measure central hemodynamics and arterial stiffness by non-invasive methods using SphygmocoR (Atcor Medical, Sydney, Australia) before and after the procedure.

Endograft group

Patients treated for abdominal aortic aneurysm with endograft will be measured for central hemodynamics and arterial stiffness by non-invasive methods.

non-invasive methods

Intervention Type OTHER

To measure central hemodynamics and arterial stiffness by non-invasive methods using SphygmocoR (Atcor Medical, Sydney, Australia) before and after the procedure.

Interventions

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non-invasive methods

To measure central hemodynamics and arterial stiffness by non-invasive methods using SphygmocoR (Atcor Medical, Sydney, Australia) before and after the procedure.

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

* Patients with diagnosis of abdominal aortic aneurysm requiring repair (open or endovascular) based on guidelines criteria for management.

Exclusion Criteria

* Patients who don´t want to enter in the study.
* Patients who don´t want to sign the informed consent.
Minimum Eligible Age

50 Years

Maximum Eligible Age

90 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Hospital Universitario Ramon y Cajal

OTHER

Sponsor Role lead

Responsible Party

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Andrés Reyes Valdivia

Vascular Surgery Consultant. MD, FEBVS

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Andrés Reyes, Consultant

Role: PRINCIPAL_INVESTIGATOR

Hospital Universitario Ramon y Cajal

Locations

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Vascular Surgery Department

Madrid, , Spain

Site Status

Countries

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Spain

References

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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.

Reference Type BACKGROUND
PMID: 20054420 (View on PubMed)

Kadoglou 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.

Reference Type BACKGROUND
PMID: 23046333 (View on PubMed)

Kadoglou 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.

Reference Type BACKGROUND
PMID: 25453890 (View on PubMed)

Lantelme 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.

Reference Type BACKGROUND
PMID: 19342960 (View on PubMed)

Valdivia 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.

Reference Type DERIVED
PMID: 30802592 (View on PubMed)

Other Identifiers

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IMPACT001

Identifier Type: -

Identifier Source: org_study_id

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