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

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.

Study Overview

• Status: Completed
• Conditions: Aortic Aneurysm, Abdominal
• Intervention / Treatment: Other: non-invasive methods

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 Type: Observational
• Enrollment (Actual): 52

Contacts and Locations

Study Locations

• Spain
  • Madrid, Spain, 28034
    • Vascular Surgery Department

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 50 years to 90 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• 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.

Description

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.

Study Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Prospective

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
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.	Other: 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.
Endograft group; Patients treated for abdominal aortic aneurysm with endograft will be measured for central hemodynamics and arterial stiffness by non-invasive methods.	Other: 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Aix@75	Augmentation Index corrected to 75 bpm	Before surgery
AIx@75	Augmentation Index corrected to 75 bpm	2 months after Surgery

Secondary Outcome Measures

Outcome Measure	Time Frame
Central Blood Pressure	before surgery
Carotid Radial Pulse Wave Velocity	before surgery
Carotid Radial Pulse Wave Velocity	2 months after surgery

Collaborators and Investigators

• Sponsor: Hospital Universitario Ramon y Cajal
• Investigators: Principal Investigator: Andrés Reyes, Consultant, Hospital Universitario Ramon y Cajal

Publications and helpful links

General 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.
• 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.
• 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.
• 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.
• 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.

Study record dates

Study Major Dates

• Study Start: January 1, 2016
• Primary Completion (Actual): January 1, 2017
• Study Completion (Actual): February 1, 2017

Study Registration Dates

• First Submitted: December 28, 2015
• First Submitted That Met QC Criteria: December 28, 2015
• First Posted (Estimate): December 30, 2015

Study Record Updates

• Last Update Posted (Actual): January 30, 2019
• Last Update Submitted That Met QC Criteria: August 12, 2018
• Last Verified: August 1, 2018

More Information

Terms related to this study

• Keywords: arterial stiffness, central hemodynamics
• Additional Relevant MeSH Terms: Cardiovascular Diseases; Vascular Diseases; Aortic Diseases; Aneurysm; Aortic Aneurysm; Aortic Aneurysm, Abdominal
• Other Study ID Numbers: IMPACT001

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: Undecided