Clinical Trials Directory

Trials / Completed

CompletedNCT02493296

The Effect of Surgery on Central Aortic Pressure & haEmodynamics Study

Status
Completed
Phase
Study type
Observational
Enrollment
146 (actual)
Sponsor
University of Leicester · Academic / Other
Sex
All
Age
18 Years
Healthy volunteers
Not accepted

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

Conditions

Interventions

TypeNameDescription
OTHERThis observational study will not entail an intervention.This study will entail measurement of central aortic haemodynamics before and after (clinically indicated) abdominal aortic aneurysm repair

Timeline

Start date
2010-10-07
Primary completion
2018-08-02
Completion
2018-08-02
First posted
2015-07-09
Last updated
2020-01-30

Locations

1 site across 1 country: United Kingdom

Source: ClinicalTrials.gov record NCT02493296. Inclusion in this directory is not an endorsement.