NCT03864497

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.

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
403

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Sep 2007

Longer than P75 for all trials

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 1, 2007

Completed
11.5 years until next milestone

First Submitted

Initial submission to the registry

March 4, 2019

Completed
2 days until next milestone

First Posted

Study publicly available on registry

March 6, 2019

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2019

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2019

Completed
Last Updated

June 19, 2019

Status Verified

June 1, 2019

Enrollment Period

11.8 years

First QC Date

March 4, 2019

Last Update Submit

June 16, 2019

Conditions

Outcome Measures

Primary Outcomes (1)

  • Cardiovascular mortality

    10 years

Secondary Outcomes (2)

  • Major adverse cardiovascular event

    10 years

  • All-cause mortality

    10 years

Study Arms (1)

Orthotopic liver transplantation candidates

No intervention, imaging test and risk stratification as part of routine clinical care.

Procedure: Myocardial perfusion imaging

Interventions

Orthotopic liver transplantation candidates

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-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.

You may qualify if:

  • 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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (1)

  • 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.

MeSH Terms

Conditions

Liver Failure

Condition Hierarchy (Ancestors)

Hepatic InsufficiencyLiver DiseasesDigestive System Diseases

Study Officials

  • Richard P Steeds, MD

    University Hospital Birmingham NHS Foundation Trust

    STUDY DIRECTOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Consultant Cardiologist with a Specialist Interest in Cardiac Imaging

Study Record Dates

First Submitted

March 4, 2019

First Posted

March 6, 2019

Study Start

September 1, 2007

Primary Completion

June 1, 2019

Study Completion

June 1, 2019

Last Updated

June 19, 2019

Record last verified: 2019-06

Data Sharing

IPD Sharing
Will not share