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Completed

NCT Number: NCT03864497

Myocardial Perfusion Imaging in Liver Transplantation Candidates

The optimal screening strategy for assessment of coronary artery disease in patients with end-stage liver disease (ESLD) is unclear. Although consensus based guidelines support noninvasive stress testing prior to orthotopic liver transplantation (OLT), no prospective studies are available to inform the clinician on perioperative risk stratification. This observational cohort study was designed to determine the prognostic utility of single photon emission computed tomography (SPECT) imaging in OLT candidates.

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Key information

Conditions

Myocardial Perfusion Imaging Digestive System Diseases Hepatic Insufficiency Liver Diseases Liver Failure

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

About this study

Controversy over whether SPECT imaging offers clinical utility in ESLD has been fuelled by conflicting reports on its accuracy to diagnose CAD in this setting. Moreover, there are no studies examining whether SPECT imaging provides any incremental prognostic value beyond functional testing in this high-risk cohort. We sought to determine the relative importance of CV risk factors, functional capacity and SPECT perfusion results as independent predictors of cardiovascular mortality in OLT candidates.

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Liver transplantation candidates with one or more of the following:
  • inability to perform >4 METs by history
  • insulin-treated diabetes mellitus
  • serum creatinine >152μmol/l
  • history of MI, PCI or CABG
  • stable angina
  • cerebrovascular disease
  • peripheral vascular disease

Exclusion criteria

  • Age < 18 years
  • Pregnancy
  • Contraindication to liver transplantation

Treatment and study plan

Myocardial perfusion imaging

Procedure

Primary outcomes

  1. Cardiovascular mortality

    Time frame: 10 years

Secondary outcomes

  1. Major adverse cardiovascular event

    Time frame: 10 years

  2. All-cause mortality

    Time frame: 10 years

Sponsors and collaborators

Lead sponsor

University Hospital Birmingham NHS Foundation Trust

Other

Registry information

Official study title

Exercise Capacity and Single Photon Emission Computed Tomography in Liver Transplantation Candidates Study

Acronym: ExSPECT

Important dates

Study start
2007
Primary completion
2019
Study completion
2019
First posted
Mar 6, 2019
Registry last updated
Jun 19, 2019

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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