Clinical trial NCT02642952: Impact of Grafts and Endografts for Abdominal Aneurysms on Arterial Stiffness.
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.
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Aortic Aneurysm, Abdominal
Keywords: arterial stiffness, central hemodynamics
Lead sponsor: Hospital Universitario Ramon y Cajal
Sponsor class: OTHER
First posted: 2015-12-30
Enrollment: 52
Sex: ALL
Minimum age (years): 50
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients consecutive treated for abdominal aortic aneurysm. The election of treatment is selected based on morphology and health status.

Brief 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.

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).

Eligibility criteria: 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.

Primary outcomes:
measure: Aix@75
timeFrame: Before surgery
measure: AIx@75
timeFrame: 2 months after Surgery
Secondary outcomes:
measure: Central Blood Pressure
timeFrame: before surgery
measure: Carotid Radial Pulse Wave Velocity
timeFrame: before surgery
measure: Carotid Radial Pulse Wave Velocity
timeFrame: 2 months after surgery
Other outcomes:
Locations:
city: Madrid
country: Spain
facility: Vascular Surgery Department
Study officials:
affiliation: Hospital Universitario Ramon y Cajal
name: Andrés Reyes, Consultant
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.