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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04089969
Recruitment Status : Recruiting
First Posted : September 16, 2019
Last Update Posted : November 6, 2019
Sponsor:
Information provided by (Responsible Party):
Robert Safian, William Beaumont Hospitals

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.

Condition or disease Intervention/treatment Phase
Coronary Artery Disease Acute Liver Failure Liver Transplant Diagnostic Test: CTA/FFRct Diagnostic Test: SOC cardiovascular evaluation Not Applicable

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).

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 100 participants
Intervention Model: Sequential Assignment
Intervention Model Description: Single-Blind decision-making study.
Masking: None (Open Label)
Primary Purpose: Diagnostic
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.
Actual Study Start Date : November 1, 2019
Estimated Primary Completion Date : November 1, 2022
Estimated Study Completion Date : November 30, 2023

Resource links provided by the National Library of Medicine


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.




Primary Outcome Measures :
  1. Change in clinical recommendation [ Time Frame: within 2 weeks after SOC assessment ]
    Number of Participants whose clinical recommendation as initially determined by SOC assessment is changed following CTA/FFRct assessment.


Secondary Outcome Measures :
  1. Frequency of detecting Coronary Artery Disease (CAD) by CTA/FFRct [ Time Frame: within 2 weeks after SOC assessment ]
    Number of Participants with agreement in CAD status detected by both Pharmacological stress test and also CTA/FFRct.

  2. Cardiovascular morbidity [ Time Frame: 1 year ]
    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

  3. Projected Health Care Cost [ Time Frame: within 2 weeks after SOC assessment ]
    Dollar value of Standard of care treatment (related to CAD) and CTA/FFRct

  4. Frequency of Detecting Myocardial Ischemia and the frequency of detecting the correct territory of the Myocardial Ischemia. [ Time Frame: within 2 weeks after SOC assessment ]
    Number of participants with Myocardial Ischemia and correct territory of Myocardial Ischemia detected by Pharmacological Stress Test vs CTA/FFRct



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04089969


Contacts
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Contact: Robert Safian, MD. (248) 898 4561 Robert.Safian@beaumont.edu
Contact: Diedre Brunk, MSA (248) 898 5580 diedre.brunk@beaumont.org

Locations
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United States, Michigan
William Beaumont Hospital Recruiting
Royal Oak, Michigan, United States, 48073
Contact: Diedre Brunl, RN. MBA.    248-898-5580    diedre.brunk@beaumont.org   
Contact: Grace San Agustin, BSN. RN.    248 551 7835    grace.sanagustin@beaumont.org   
Principal Investigator: Robert Safian, MD.         
Sponsors and Collaborators
William Beaumont Hospitals
Investigators
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Principal Investigator: Robert Safian, MD William Beaumont Hospitals

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Responsible Party: Robert Safian, MD., William Beaumont Hospitals
ClinicalTrials.gov Identifier: NCT04089969    
Other Study ID Numbers: 2019-151
First Posted: September 16, 2019    Key Record Dates
Last Update Posted: November 6, 2019
Last Verified: November 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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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
Keywords provided by Robert Safian, William Beaumont Hospitals:
CTA, FFRct, CAD
End Stage Liver DIsease
Liver failure, Liver transplant
Additional relevant MeSH terms:
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Liver Failure
Hepatic Insufficiency
End Stage Liver Disease
Liver Failure, Acute
Coronary Artery Disease
Coronary Disease
Myocardial Ischemia
Heart Diseases
Cardiovascular Diseases
Arteriosclerosis
Arterial Occlusive Diseases
Vascular Diseases
Liver Diseases
Digestive System Diseases