Brief Title
The Effect of Surgery on Central Aortic Pressure & haEmodynamics Study
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.
Detailed Description
Increased pulse pressure and pulse-wave velocity are recognized indices of arterial stiffness (Laurent, Boutouyrie, Asmar et al., 2001; Qiu, Winblad, Viitanen et al., 2003). An increased pulse pressure (indicative of increased central aortic pressure) is independently associated with an increased incidence of postoperative neurological and cardiac complications (Fontes, Aronson, Matthew et al., 2008). Pulse pressure has been identified as an independent predictor of cerebrovascular events after cardiac surgery (Benjo, Thompson, Fine et al., 2007). Moreover, many studies have demonstrated that pulse-wave velocity is an independent predictor of morbidity and mortality in a range of study populations (for a review see Vlachopoulos, Aznaouridis, Stefanadis, 2010). An increasing body of evidence suggests that brachial artery pressure, although representative, is not an accurate reflection of central aortic pressure. The Conduit Artery Function Evaluation study, for example, revealed that certain drugs preferentially reduce central aortic pressure, whilst having similar effects on brachial artery pressure. Moreover, in this study central aortic pulse pressure was demonstrated to be an independent predictor of clinical outcomes (Williams, Lacy, Thom et al., 2006). Other studies support the finding that markers of CAP are more closely related to surrogate measures of cardiovascular risk such as left ventricular mass (Haider, Larson, Franklin et al., 2003) and carotid intima-media thickness (Kostis, Davis, Cutler et al., 1997). One inadvertent effect of stenting is the introduction of a semi rigid conduit into the circulation. This could potentially increase pulse wave velocity and adversely affect central aortic pressures and haemodynamics. The investigators thus aim to investigate the effect of aortic aneurysm of surgery on central aortic pressures and haemodynamics
Study Type
Observational
Primary Outcome
Pulse wave velocity
Secondary Outcome
Central aortic pressure
Condition
Abdominal Aortic Aneurysm
Intervention
This observational study will not entail an intervention.
Study Arms / Comparison Groups
Observational
Description: 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.
Publications
* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.
Recruitment Information
Recruitment Status
Other
Estimated Enrollment
146
Start Date
October 7, 2010
Completion Date
August 2, 2018
Primary Completion Date
August 2, 2018
Eligibility Criteria
Inclusion Criteria: - All participants undergoing abdominal aortic aneurysm repair, with non-atheromatous common carotid arteries. Exclusion Criteria: - Atheromatous carotid arteries
Gender
All
Ages
18 Years - N/A
Accepts Healthy Volunteers
No
Contacts
Vimal J Gokani, MBBS MRCS, ,
Location Countries
United Kingdom
Location Countries
United Kingdom
Administrative Informations
NCT ID
NCT02493296
Organization ID
0066
Responsible Party
Sponsor
Study Sponsor
University of Leicester
Collaborators
British Heart Foundation
Study Sponsor
Vimal J Gokani, MBBS MRCS, Principal Investigator, University of Leicester
Verification Date
January 2020