NCT02493296

Brief Summary

The present study will investigate the effect of artificially stiffening the aorta by means of an aortic stent on central aortic haemodynamics (CAH). This study will determine whether aortic stenting inadvertently adversely impacts on CAH, thereby providing the rational for subsequent therapeutic intervention to reduce the associated cardiovascular risk.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
146

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Oct 2010

Longer than P75 for all trials

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

Study Start

First participant enrolled

October 7, 2010

Completed
4.7 years until next milestone

First Submitted

Initial submission to the registry

July 6, 2015

Completed
3 days until next milestone

First Posted

Study publicly available on registry

July 9, 2015

Completed
3.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 2, 2018

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 2, 2018

Completed
Last Updated

January 30, 2020

Status Verified

January 1, 2020

Enrollment Period

7.8 years

First QC Date

July 6, 2015

Last Update Submit

January 29, 2020

Conditions

Abdominal Aortic AneurysmPulse Wave AnalysisRisk

Outcome Measures

Primary Outcomes (1)

  • Pulse wave velocity

    One year

Secondary Outcomes (1)

  • Central aortic pressure

    1 Year

Study Arms (1)

Observational

The cohort will have their central aortic pressure, and carotid-femoral and brachio-femoral pulse-wave velocities measured. These measurements will take place pre-operatively, within a week of surgery, 6-weeks and 1-year post-operatively also. The surgery will be abdominal aortic aneurysm repair.

Other: This observational study will not entail an intervention.

Interventions

This observational study will not entail an intervention.OTHER

This study will entail measurement of central aortic haemodynamics before and after (clinically indicated) abdominal aortic aneurysm repair

Observational

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

All participants undergoing abdominal aortic aneurysm repair who are over 18, and are able to consent to the study.

You may qualify if:

  • All participants undergoing abdominal aortic aneurysm repair, with non-atheromatous common carotid arteries.

You may not qualify if:

  • Atheromatous carotid arteries

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Leicester

Leicester, LE1 5WW, United Kingdom

Location

MeSH Terms

Conditions

Aortic Aneurysm, Abdominal

Condition Hierarchy (Ancestors)

Aortic AneurysmAneurysmVascular DiseasesCardiovascular DiseasesAortic Diseases

Study Officials

  • Vimal J Gokani, MBBS MRCS

    University of Leicester

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 6, 2015

First Posted

July 9, 2015

Study Start

October 7, 2010

Primary Completion

August 2, 2018

Study Completion

August 2, 2018

Last Updated

January 30, 2020

Record last verified: 2020-01

Locations

GB(1)