Myocardial Perfusion Imaging in Liver Transplantation Candidates

Liver Failure Clinical Trial

— ExSPECT  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03864497
• Other study ID #: CARMS-14536
• Status: Completed
• Start date: September 2007
• Est. completion date: June 2019

Study information

• Verified date: June 2019
• Source: University Hospital Birmingham NHS Foundation Trust
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

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.

Description:

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 403
• Est. completion date: June 2019
• Est. primary completion date: June 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Hepatic Insufficiency
• Liver Failure
• Myocardial Perfusion Imaging

Intervention

Procedure:
• Myocardial perfusion imaging

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
University Hospital Birmingham NHS Foundation Trust

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Cardiovascular mortality		10 years
Secondary	Major adverse cardiovascular event		10 years
Secondary	All-cause mortality		10 years