NCT02642952

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
52

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Jan 2016

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

December 28, 2015

Completed
2 days until next milestone

First Posted

Study publicly available on registry

December 30, 2015

Completed
2 days until next milestone

Study Start

First participant enrolled

January 1, 2016

Completed
1 year until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2017

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2017

Completed
2 years until next milestone

Results Posted

Study results publicly available

January 30, 2019

Completed
Last Updated

January 30, 2019

Status Verified

August 1, 2018

Enrollment Period

1 year

First QC Date

December 28, 2015

Results QC Date

August 12, 2018

Last Update Submit

August 12, 2018

Conditions

Aortic Aneurysm, Abdominal

Keywords

arterial stiffness, central hemodynamics

Outcome Measures

Primary Outcomes (2)

  • Aix@75

    Augmentation Index corrected to 75 bpm

    Before surgery

  • AIx@75

    Augmentation Index corrected to 75 bpm

    2 months after Surgery

Secondary Outcomes (3)

  • Central Blood Pressure

    before surgery

  • Carotid Radial Pulse Wave Velocity

    before surgery

  • Carotid Radial Pulse Wave Velocity

    2 months after surgery

Study Arms (2)

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

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

Interventions

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.

Endograft groupOpen-graft group

Eligibility Criteria

Age50 Years - 90 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Patients consecutive treated for abdominal aortic aneurysm. The election of treatment is selected based on morphology and health status.

You may qualify if:

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

You may not qualify if:

  • Patients who don´t want to enter in the study.
  • Patients who don´t want to sign the informed consent.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Vascular Surgery Department

Madrid, 28034, Spain

Location

Related Publications (5)

  • 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.

    PMID: 20054420BACKGROUND

  • 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.

    PMID: 23046333BACKGROUND

  • 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.

    PMID: 25453890BACKGROUND

  • 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.

    PMID: 19342960BACKGROUND

  • 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.

    PMID: 30802592DERIVED

MeSH Terms

Conditions

Aortic Aneurysm, Abdominal

Condition Hierarchy (Ancestors)

Aortic AneurysmAneurysmVascular DiseasesCardiovascular DiseasesAortic Diseases

Results Point of Contact

Title
Dr. Andrés Reyes Valdivia
Organization
Ramón y Cajal University Hospital
cauzaza@hotmail.com
0034 629586239

Study Officials

  • Andrés Reyes, Consultant

    Hospital Universitario Ramon y Cajal

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
Yes

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Vascular Surgery Consultant. MD, FEBVS

Study Record Dates

First Submitted

December 28, 2015

First Posted

December 30, 2015

Study Start

January 1, 2016

Primary Completion

January 1, 2017

Study Completion

February 1, 2017

Last Updated

January 30, 2019

Results First Posted

January 30, 2019

Record last verified: 2018-08

Locations

ES(1)