The Effect of Surgery on Central Aortic Pressure & haEmodynamics Study

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Abdominal aortic aneurysm
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Cook – Abdominal aortic aneurysm Cordis Corporation – Abdominal Aortic Aneurysm
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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