Cardiac Risk Assessment Using Standard of Care Versus CTA and Heart Flow FFRct (CRASCH-Liver)

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.

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.

Study Overview

• Status: Withdrawn
• Conditions: Coronary Artery Disease; Acute Liver Failure; Liver Transplant
• Intervention / Treatment: Diagnostic test: CTA/FFRct; Diagnostic test: SOC cardiovascular evaluation

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 Type: Interventional
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Michigan
    • Royal Oak, Michigan, United States, 48073
      • William Beaumont Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Diagnostic
• Allocation: N/A
• Interventional Model: Sequential Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Evaluation of Standard of care followed by 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	Diagnostic test: CTA/FFRct; Computed Tomography Angiogram with Fractional Flow Reserve. A Ct scan of the heart's blood vessels.; Diagnostic test: SOC cardiovascular evaluation; 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.

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: William Beaumont Hospitals

Study record dates

Study Major Dates

• Study Start (Anticipated): June 1, 2023
• Primary Completion (Anticipated): June 1, 2024
• Study Completion (Anticipated): June 1, 2024

Study Registration Dates

• First Submitted: September 12, 2019
• First Submitted That Met QC Criteria: September 12, 2019
• First Posted (Actual): September 16, 2019

Study Record Updates

• Last Update Posted (Actual): March 2, 2023
• Last Update Submitted That Met QC Criteria: February 28, 2023
• Last Verified: February 1, 2023

More Information

Terms related to this study

• Keywords: End Stage Liver DIsease; CTA, FFRct, CAD; Liver failure, Liver transplant
• Additional Relevant MeSH Terms: Digestive System Diseases; Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Vascular Diseases; Arteriosclerosis; Arterial Occlusive Diseases; Liver Diseases; Coronary Disease; End Stage Liver Disease; Coronary Artery Disease; Liver Failure; Hepatic Insufficiency; Liver Failure, Acute
• Other Study ID Numbers: 2019-151

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: Yes