Clinical trial NCT03864497: Myocardial Perfusion Imaging in Liver Transplantation Candidates
Official title: Exercise Capacity and Single Photon Emission Computed Tomography in Liver Transplantation Candidates Study
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Myocardial Perfusion Imaging
Liver Failure
Lead sponsor: University Hospital Birmingham NHS Foundation Trust
Sponsor class: OTHER
First posted: 2019-03-06
Enrollment: 403
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
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.

Brief 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.

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.

Eligibility criteria: 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

Primary outcomes:
measure: Cardiovascular mortality
timeFrame: 10 years
Secondary outcomes:
measure: Major adverse cardiovascular event
timeFrame: 10 years
measure: All-cause mortality
timeFrame: 10 years
Other outcomes:
Locations:
Study officials:
affiliation: University Hospital Birmingham NHS Foundation Trust
name: Richard P Steeds, MD
role: STUDY_DIRECTOR
References:
citation: Moody WE, Holloway B, Arumugam P, Gill S, Wahid YS, Boivin CM, Thomson LE, Berman DS, Armstrong MJ, Ferguson J, Steeds RP. Prognostic value of coronary risk factors, exercise capacity and single photon emission computed tomography in liver transplantation candidates: A 5-year follow-up study. J Nucl Cardiol. 2021 Dec;28(6):2876-2891. doi: 10.1007/s12350-020-02126-z. Epub 2020 May 11.