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The Effect of Surgery on Central Aortic Pressure & haEmodynamics Study

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT02493296
Acronym
ESCAPE
Enrollment
146
Registered
2015-07-09
Start date
2010-10-07
Completion date
2018-08-02
Last updated
2020-01-30

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Abdominal Aortic Aneurysm, Pulse Wave Analysis, Risk

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

Interventions

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

Sponsors

British Heart Foundation
CollaboratorOTHER
University of Leicester
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

Inclusion criteria

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

Exclusion criteria

* Atheromatous carotid arteries

Design outcomes

Primary

MeasureTime frame
Pulse wave velocityOne year

Secondary

MeasureTime frame
Central aortic pressure1 Year

Countries

United Kingdom

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026