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

NCT ID: NCT04089969

Last Updated: 2023-03-02

Basic Information

• Recruitment Status: WITHDRAWN
• Clinical Phase: NA
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-06-30
• Study Completion Date: 2024-06-30

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).

Conditions

Coronary Artery Disease; Acute Liver Failure; Liver Transplant

Study Design

• Allocation Method: NA
• Intervention Model: SEQUENTIAL
• Primary Study Purpose: DIAGNOSTIC
• Blinding Strategy: NONE

Study Groups

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

Group Type: EXPERIMENTAL

CTA/FFRct

Intervention Type: DIAGNOSTIC_TEST

Computed Tomography Angiogram with Fractional Flow Reserve. A Ct scan of the heart's blood vessels.

SOC cardiovascular evaluation

Intervention Type: DIAGNOSTIC_TEST

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.

Interventions

CTA/FFRct

Computed Tomography Angiogram with Fractional Flow Reserve. A Ct scan of the heart's blood vessels.

Intervention Type: 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.

Intervention Type: DIAGNOSTIC_TEST

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

William Beaumont Hospitals

OTHER

Sponsor Role: lead

Responsible Party

Robert Safian

MD.

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Robert Safian, MD

Role: PRINCIPAL_INVESTIGATOR

William Beaumont Hospitals

Other Identifiers

2019-151

Identifier Type: -

Identifier Source: org_study_id