Clinical trial NCT04089969: Cardiac Risk Assessment Using Standard of Care Versus CTA and Heart Flow FFRct
Official title: 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.
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: NA
Conditions: Coronary Artery Disease
Acute Liver Failure
Liver Transplant
Keywords: CTA, FFRct, CAD
End Stage Liver DIsease
Liver failure, Liver transplant
Lead sponsor: William Beaumont Hospitals
Sponsor class: OTHER
First posted: 2019-09-16
Enrollment: 0
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SEQUENTIAL
Intervention model description: Single-Blind decision-making study.
Primary purpose: DIAGNOSTIC

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).

Eligibility criteria: 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

Primary outcomes:
measure: Change in clinical recommendation
timeFrame: within 2 weeks after SOC assessment
Secondary outcomes:
measure: Frequency of detecting Coronary Artery Disease (CAD) by CTA/FFRct
timeFrame: within 2 weeks after SOC assessment
measure: Cardiovascular morbidity
timeFrame: 1 year
measure: Projected Health Care Cost
timeFrame: within 2 weeks after SOC assessment
measure: Frequency of Detecting Myocardial Ischemia and the frequency of detecting the correct territory of the Myocardial Ischemia.
timeFrame: within 2 weeks after SOC assessment
Other outcomes:
Locations:
Study officials:
affiliation: William Beaumont Hospitals
name: Robert Safian, MD
role: PRINCIPAL_INVESTIGATOR
References: