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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT03864497
Other study ID # CARMS-14536
Secondary ID
Status Completed
Phase
First received
Last updated
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
Health authority
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

Study Design


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
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