Myocardial Perfusion Imaging in Liver Transplantation Candidates

NCT ID: NCT03864497

Last Updated: 2019-06-19

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

403 participants

Study Classification

OBSERVATIONAL

Study Start Date

2007-09-30

Study Completion Date

2019-06-30

Brief Summary

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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

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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.

Conditions

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Myocardial Perfusion Imaging Liver Failure

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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Orthotopic liver transplantation candidates

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

Myocardial perfusion imaging

Intervention Type PROCEDURE

Interventions

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Myocardial perfusion imaging

Intervention Type PROCEDURE

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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University Hospital Birmingham NHS Foundation Trust

OTHER

Sponsor Role lead

Responsible Party

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William E Moody

Consultant Cardiologist with a Specialist Interest in Cardiac Imaging

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Richard P Steeds, MD

Role: STUDY_DIRECTOR

University Hospital Birmingham NHS Foundation Trust

References

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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.

Reference Type DERIVED
PMID: 32394403 (View on PubMed)

Other Identifiers

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CARMS-14536

Identifier Type: -

Identifier Source: org_study_id

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