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

Primary Purpose

Coronary Artery Disease, Acute Liver Failure, Liver Transplant

Status
Withdrawn
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
CTA/FFRct
SOC cardiovascular evaluation
Sponsored by
William Beaumont Hospitals
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Coronary Artery Disease focused on measuring CTA, FFRct, CAD, End Stage Liver DIsease, Liver failure, Liver transplant

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

    Arms of the Study

    Arm 1

    Arm Type

    Experimental

    Arm Label

    Evaluation of Standard of care followed by CTA/FFRct

    Arm Description

    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

    Outcomes

    Primary Outcome Measures

    Change in clinical recommendation
    Number of Participants whose clinical recommendation as initially determined by SOC assessment is changed following CTA/FFRct assessment.

    Secondary Outcome Measures

    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.
    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
    Projected Health Care Cost
    Dollar value of Standard of care treatment (related to CAD) and CTA/FFRct
    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

    Full Information

    First Posted
    September 12, 2019
    Last Updated
    February 28, 2023
    Sponsor
    William Beaumont Hospitals
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    1. Study Identification

    Unique Protocol Identification Number
    NCT04089969
    Brief Title
    Cardiac Risk Assessment Using Standard of Care Versus CTA and Heart Flow FFRct
    Acronym
    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.
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    February 2023
    Overall Recruitment Status
    Withdrawn
    Why Stopped
    Essential staff for study execution left the institution and no suitable replacement could be found.
    Study Start Date
    June 2023 (Anticipated)
    Primary Completion Date
    June 2024 (Anticipated)
    Study Completion Date
    June 2024 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    William Beaumont Hospitals

    4. Oversight

    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
    Data Monitoring Committee
    Yes

    5. Study Description

    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).

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Coronary Artery Disease, Acute Liver Failure, Liver Transplant
    Keywords
    CTA, FFRct, CAD, End Stage Liver DIsease, Liver failure, Liver transplant

    7. Study Design

    Primary Purpose
    Diagnostic
    Study Phase
    Not Applicable
    Interventional Study Model
    Sequential Assignment
    Model Description
    Single-Blind decision-making study.
    Masking
    None (Open Label)
    Allocation
    N/A
    Enrollment
    0 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    Evaluation of Standard of care followed by CTA/FFRct
    Arm Type
    Experimental
    Arm Description
    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
    Intervention Type
    Diagnostic Test
    Intervention Name(s)
    CTA/FFRct
    Intervention Description
    Computed Tomography Angiogram with Fractional Flow Reserve. A Ct scan of the heart's blood vessels.
    Intervention Type
    Diagnostic Test
    Intervention Name(s)
    SOC cardiovascular evaluation
    Intervention Description
    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.
    Primary Outcome Measure Information:
    Title
    Change in clinical recommendation
    Description
    Number of Participants whose clinical recommendation as initially determined by SOC assessment is changed following CTA/FFRct assessment.
    Time Frame
    within 2 weeks after SOC assessment
    Secondary Outcome Measure Information:
    Title
    Frequency of detecting Coronary Artery Disease (CAD) by CTA/FFRct
    Description
    Number of Participants with agreement in CAD status detected by both Pharmacological stress test and also CTA/FFRct.
    Time Frame
    within 2 weeks after SOC assessment
    Title
    Cardiovascular morbidity
    Description
    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
    Time Frame
    1 year
    Title
    Projected Health Care Cost
    Description
    Dollar value of Standard of care treatment (related to CAD) and CTA/FFRct
    Time Frame
    within 2 weeks after SOC assessment
    Title
    Frequency of Detecting Myocardial Ischemia and the frequency of detecting the correct territory of the Myocardial Ischemia.
    Description
    Number of participants with Myocardial Ischemia and correct territory of Myocardial Ischemia detected by Pharmacological Stress Test vs CTA/FFRct
    Time Frame
    within 2 weeks after SOC assessment

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: Patients with end-stage liver disease Patients undergoing cardiovascular risk assessment prior to liver transplantation - Exclusion Criteria: Estimated Glomerular Filtration Rate (eGFR) < 30 cc/min/1.73 m^2 (unless patient is on dialysis or renal transplant is planned) Heart rate > 90 bpm despite beta blocker therapy Body Mass Index (BMI) > 40 plus chest obesity (i.e. truncal obesity and normal chest morphology is not an exclusion) Pregnant Women
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Robert Safian, MD
    Organizational Affiliation
    William Beaumont Hospitals
    Official's Role
    Principal Investigator

    12. IPD Sharing Statement

    Plan to Share IPD
    No

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