Ignite Creation Date:
2024-05-06 @ 1:39 PM
Last Modification Date:
2024-10-26 @ 1:18 PM
Study NCT ID:
NCT04089969
Status:
WITHDRAWN
Last Update Posted:
2023-03-02
First Post:
2019-09-12
Brief Title:
Cardiac Risk Assessment Using Standard of Care Versus CTA and Heart Flow FFRct
Sponsor:
William Beaumont Hospitals
Organization:
William Beaumont Hospitals
Study Overview
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
Status:
WITHDRAWN
Status Verified Date:
2023-02
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Essential staff for study execution left the institution and no suitable replacement could be found
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
CRASCH-Liver
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 eg 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 CTAFFRct The referring cardiologist will be blinded to the results of CTAFFRct 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 CTAFFRct 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 CTAFFRct is superior to SOC cardiovascular evaluation stress etst echocardiogram ECG This study will look at the frequency of how often CTAFFRct changed the clinical recommendation compared with the standard of care alone Initial recommendation versus final recommendation
All 100 patients will undergo standard of care stress test plus CTAFFRct The referring cardiologist will be blinded to the results of CTAFFRct 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 CTAFFRct 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 CTAFFRct is superior to SOC cardiovascular evaluation stress etst echocardiogram ECG This study will look at the frequency of how often CTAFFRct changed the clinical recommendation compared with the standard of care alone Initial recommendation versus final recommendation
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
True
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
True
Is an FDA AA801 Violation?:
None