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

Coronary Artery Disease Clinical Trial

— CRASCH-Liver  

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.

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT04089969
• Other study ID #: 2019-151
• Status: Withdrawn
• Phase: N/A
• Start date: June 2023
• Est. completion date: June 2024

Study information

• Verified date: February 2023
• Source: William Beaumont Hospitals
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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).

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: June 2024
• Est. primary completion date: June 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Acute Liver Failure
• Coronary Artery Disease
• End Stage Liver Disease
• Hepatic Insufficiency
• Liver Failure
• Liver Failure, Acute
• Liver Transplant

Intervention

Diagnostic Test:
• CTA/FFRct
Computed Tomography Angiogram with Fractional Flow Reserve. A Ct scan of the heart's blood vessels.
• 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.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
William Beaumont Hospitals

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	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
Secondary	Projected Health Care Cost	Dollar value of Standard of care treatment (related to CAD) and CTA/FFRct	within 2 weeks after SOC assessment
Secondary	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