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Completed

NCT Number: NCT02493296

The Effect of Surgery on Central Aortic Pressure & haEmodynamics Study

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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

University of Leicester

Leicester, LE1 5WW, United Kingdom

About this study

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

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Exclusion criteria

  • Atheromatous carotid arteries

Treatment and study plan

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

Primary outcomes

  1. Pulse wave velocity

    Time frame: One year

Secondary outcomes

  1. Central aortic pressure

    Time frame: 1 Year

Sponsors and collaborators

Lead sponsor

University of Leicester

Other

Collaborators

  • British Heart Foundation

Registry information

Acronym: ESCAPE

Important dates

Study start
2010
Primary completion
2018
Study completion
2018
First posted
Jul 9, 2015
Registry last updated
Jan 30, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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