Myocardial Perfusion Imaging in Liver Transplantation Candidates (ExSPECT)

June 16, 2019 updated by: William E Moody, University Hospital Birmingham NHS Foundation Trust

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed 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.

Study Type

Observational

Enrollment (Actual)

403

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Consecutive patients with end-stage liver disease were identified after referral to the Queen Elizabeth Hospital Birmingham for CV risk stratification as part of a pre-transplant screening work-up. Subjects were referred for non-invasive CV risk assessment based on the above criteria.

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Orthotopic liver transplantation candidates
No intervention, imaging test and risk stratification as part of routine clinical care.
Procedure: Myocardial perfusion imaging

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Cardiovascular mortality
Time Frame: 10 years
10 years

Secondary Outcome Measures

Outcome Measure
Time Frame
All-cause mortality
Time Frame: 10 years
10 years
Major adverse cardiovascular event
Time Frame: 10 years
10 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University Hospital Birmingham NHS Foundation Trust

Investigators

  • Study Director: Richard P Steeds, MD, University Hospital Birmingham NHS Foundation Trust

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

September 1, 2007

Primary Completion (Actual)

June 1, 2019

Study Completion (Actual)

June 1, 2019

Study Registration Dates

First Submitted

March 4, 2019

First Submitted That Met QC Criteria

March 4, 2019

First Posted (Actual)

March 6, 2019

Study Record Updates

Last Update Posted (Actual)

June 19, 2019

Last Update Submitted That Met QC Criteria

June 16, 2019

Last Verified

June 1, 2019

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CARMS-14536

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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