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

Aortic Aneurysm, Abdominal Clinical Trial

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.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02642952
• Other study ID #: IMPACT001
• Status: Completed
• Start date: January 2016
• Est. completion date: February 2017

Study information

• Verified date: August 2018
• Source: Hospital Universitario Ramon y Cajal
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical 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.

Our main goal is to measure the changes in:

Augmentation index, central blood pressure, pulse wave analysis, pulse wave velocity.

Description:

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

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 52
• Est. completion date: February 2017
• Est. primary completion date: January 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 50 Years to 90 Years

Eligibility

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.

Related Conditions & MeSH terms

• Aneurysm
• Aortic Aneurysm
• Aortic Aneurysm, Abdominal

Intervention

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.

Locations

Country	Name	City	State
Spain	Vascular Surgery Department	Madrid

Sponsors (1)

Lead Sponsor	Collaborator
Hospital Universitario Ramon y Cajal

Country where clinical trial is conducted

Spain, 

References & Publications (4)

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. — View 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. — View 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. — View 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Aix@75	Augmentation Index corrected to 75 bpm	Before surgery
Primary	AIx@75	Augmentation Index corrected to 75 bpm	2 months after Surgery
Secondary	Central Blood Pressure		before surgery
Secondary	Carotid Radial Pulse Wave Velocity		before surgery
Secondary	Carotid Radial Pulse Wave Velocity		2 months after surgery