Cardiac Risk Assessment Using Standard of Care Versus CTA and Heart Flow FFRct

Study Overview
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Brief Summary
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Coronary Artery Disease (CAD) is the narrowing or blockage of the artery of the heart and is prevalent in end-stage liver disease. Consultation with cardiologist and stress tests are recommended to patients under consideration for liver transplant. The purpose of this study is to evaluate if Computed Tomography Angiogram (CTA) and CTA-derived Fractional Flow Reserve (FFRct) procedure influences decisions about further cardiac testing compared with Standard of Care (SOC) such as consultation by a cardiologist, Echocardiogram (ultrasound of the heart), Electrocardiogram (ECG) and stress tests.

Detailed Description
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The purpose of this study is to determine in end-stage liver disease patients whether non-invasive assessment of coronary artery disease prior to liver transplant using CTA (CTA) and CTA-derived Fractional Flow Reserved (FFRct) is superior to current standard of care (SOC) cardiovascular evaluation such as formal consultation by a cardiologist, electrocardiogram, echocardiogram, and pharmacological stress test such (e.g. Dobutamine stress echocardiogram and lexiscan myocardial perfusion imaging). The investigational portion of this study is the CTA and FFRct, which is a special x-ray scan that can identify blockages in the arteries and determine if blood flow is impaired. The CTA and FFRct will be done within 2 weeks after the standard of care evaluation. All 100 patients will undergo standard of care stress test plus CTA/FFRct. The referring cardiologist will be blinded to the results of CTA/FFRct, and will make an initial recommendation based on the standard of care evaluation. After making the initial recommendation, the referring cardiologist will be unblinded to the CTA/FFRct results and make a final recommendation. The initial recommendation will consist of one of the following: further cardiac evaluation is not needed or cardiac catheterization is required. The final recommendation will consist of one of the following: further cardiac evaluation is not needed or cardiac catheterization is required. All patients will receive a 1 year phone follow up call. The hypothesis is that in End Stage Liver Disease (ESLD) patients, non-invasive assessment for CAD using CTA/FFRct is superior to SOC cardiovascular evaluation (stress etst, echocardiogram, ECG). This study will look at the frequency of how often CTA/FFRct changed the clinical recommendation compared with the standard of care alone (Initial recommendation versus final recommendation).

Official Title
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Cardiac Risk Assessment Using Standard of Care Versus CTA and Heart Flow FFRct in Patients With End-Stage Liver Disease Under Consideration for Liver Transplant.

Conditions
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Coronary Artery Disease, Acute Liver Failure, Liver Transplant

Intervention / Treatment
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* Diagnostic Test: CTA/FFRct
* Diagnostic Test: SOC cardiovascular evaluation


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patients with end-stage liver disease Patients undergoing cardiovascular risk assessment prior to liver transplantation - Exclusion Criteria: Estimated Glomerular Filtration Rate (eGFR) < 30 cc/min/1.73 m^2 (unless patient is on dialysis or renal transplant is planned) Heart rate > 90 bpm despite beta blocker therapy Body Mass Index (BMI) > 40 plus chest obesity (i.e. truncal obesity and normal chest morphology is not an exclusion) Pregnant Women

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Diagnostic
Intervention Model: Sequential Assignment
Interventional Model Description: Single-Blind decision-making study.
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Evaluation of Standard of care followed by CTA/FFRct<br>Patient received clinical recommendation based on the Standard of Care i.e 2 D echocardiogram, plus ECG, plus, pharmacological stress test followed by re-evaluation of clinical recommendation with addition of CTA/FFRct | Diagnostic Test: CTA/FFRct<br>* Computed Tomography Angiogram with Fractional Flow Reserve. A Ct scan of the heart's blood vessels.<br>Diagnostic Test: SOC cardiovascular evaluation<br>* Standard of care (SOC) cardiovascular evaluation i.e ECG, 2 D echocardiogram and pharmacologic stress test such as Dobutamine and Myocardial Perfusion Imaging stress test.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in clinical recommendation | Number of Participants whose clinical recommendation as initially determined by SOC assessment is changed following CTA/FFRct assessment. | within 2 weeks after SOC assessment | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Frequency of detecting Coronary Artery Disease (CAD) by CTA/FFRct | Number of Participants with agreement in CAD status detected by both Pharmacological stress test and also CTA/FFRct. | within 2 weeks after SOC assessment | 
| Cardiovascular morbidity | Number of participants with cardiovascular related Death, Myocardial Infarction (MI: defined as any 2 of following; 1. ischemic chest pain, 2. elevated troponin 3. pathologic Q waves or ischemic ST changes), or ischemia driven revascularization | 1 year | 
| Projected Health Care Cost | Dollar value of Standard of care treatment (related to CAD) and CTA/FFRct | within 2 weeks after SOC assessment | 
| Frequency of Detecting Myocardial Ischemia and the frequency of detecting the correct territory of the Myocardial Ischemia. | Number of participants with Myocardial Ischemia and correct territory of Myocardial Ischemia detected by Pharmacological Stress Test vs CTA/FFRct | within 2 weeks after SOC assessment | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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CTA, FFRct, CAD, End Stage Liver DIsease, Liver failure, Liver transplant