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

Not Applicable

Withdrawn

• Conditions: Liver Transplant; Acute Liver Failure; Coronary Artery Disease
• Interventions: Diagnostic Test: CTA/FFRct; Diagnostic Test: SOC cardiovascular evaluation

• Registration Number: NCT04089969
• Lead Sponsor: William Beaumont Hospitals

Brief Summary

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

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).

Study Timeline

• Study First Submitted: 2019-09-12
• Study First Submitted QC: 2019-09-12
• Study First Posted: 2019-09-16
• Status Verified: 2023-02
• Last Update Submitted: 2023-02-28
• Last Update Posted: 2023-03-02
• Study Start: 2023-06
• Primary Completion: 2024-06
• Study Completion: 2024-06

Recruitment & Eligibility

• Status: WITHDRAWN
• Sex: All
• Target Recruitment: Not specified

Inclusion Criteria

1. Patients with end-stage liver disease
2. Patients undergoing cardiovascular risk assessment prior to liver transplantation -

Exclusion Criteria

1. Estimated Glomerular Filtration Rate (eGFR) < 30 cc/min/1.73 m^2 (unless patient is on dialysis or renal transplant is planned)
2. Heart rate > 90 bpm despite beta blocker therapy
3. Body Mass Index (BMI) > 40 plus chest obesity (i.e. truncal obesity and normal chest morphology is not an exclusion)
4. Pregnant Women

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SEQUENTIAL

Arm && Interventions

Group	Intervention	Description
Evaluation of Standard of care followed by CTA/FFRct	SOC cardiovascular evaluation	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
Evaluation of Standard of care followed by CTA/FFRct	CTA/FFRct	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

Primary Outcome Measures

Name	Time	Method
Change in clinical recommendation	within 2 weeks after SOC assessment	Number of Participants whose clinical recommendation as initially determined by SOC assessment is changed following CTA/FFRct assessment.

Secondary Outcome Measures

Name	Time	Method
Projected Health Care Cost	within 2 weeks after SOC assessment	Dollar value of Standard of care treatment (related to CAD) and CTA/FFRct
Frequency of detecting Coronary Artery Disease (CAD) by CTA/FFRct	within 2 weeks after SOC assessment	Number of Participants with agreement in CAD status detected by both Pharmacological stress test and also CTA/FFRct.
Cardiovascular morbidity	1 year	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
Frequency of Detecting Myocardial Ischemia and the frequency of detecting the correct territory of the Myocardial Ischemia.	within 2 weeks after SOC assessment	Number of participants with Myocardial Ischemia and correct territory of Myocardial Ischemia detected by Pharmacological Stress Test vs CTA/FFRct