Clinical trial NCT02493296: The Effect of Surgery on Central Aortic Pressure & haEmodynamics Study
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Abdominal Aortic Aneurysm
Pulse Wave Analysis
Risk
Lead sponsor: University of Leicester
Sponsor class: OTHER
Collaborators: name: British Heart Foundation
First posted: 2015-07-09
Enrollment: 146
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: All participants undergoing abdominal aortic aneurysm repair who are over 18, and are able to consent to the 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

Eligibility criteria: Inclusion Criteria:

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

Exclusion Criteria:

* Atheromatous carotid arteries

Primary outcomes:
measure: Pulse wave velocity
timeFrame: One year
Secondary outcomes:
measure: Central aortic pressure
timeFrame: 1 Year
Other outcomes:
Locations:
city: Leicester
country: United Kingdom
facility: University of Leicester
Study officials:
affiliation: University of Leicester
name: Vimal J Gokani, MBBS MRCS
role: PRINCIPAL_INVESTIGATOR
References: