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Withdrawn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
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
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
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
NCT ID
NCT04089969
First Posted
September 12, 2019
Last Updated
February 28, 2023
Sponsor
William Beaumont Hospitals
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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Cardiac Risk Assessment Using Standard of Care Versus CTA and Heart Flow FFRct
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