- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04089969
Cardiac Risk Assessment Using Standard of Care Versus CTA and Heart Flow FFRct (CRASCH-Liver)
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 Overview
Status
Intervention / Treatment
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).
Study Type
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: Robert Safian, MD.
- Phone Number: (248) 898 4561
- Email: Robert.Safian@beaumont.edu
Study Contact Backup
- Name: Diedre Brunk, MSA
- Phone Number: (248) 898 5580
- Email: diedre.brunk@beaumont.org
Study Locations
-
-
Michigan
-
Royal Oak, Michigan, United States, 48073
- William Beaumont Hospital
-
Contact:
- Diedre Brunl, RN. MBA.
- Phone Number: 248-898-5580
- Email: diedre.brunk@beaumont.org
-
Contact:
- Grace San Agustin, BSN. RN.
- Phone Number: 248 551 7835
- Email: grace.sanagustin@beaumont.org
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Principal Investigator:
- Robert Safian, MD.
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Diagnostic
- Allocation: N/A
- Interventional Model: Sequential Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / 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
|
Computed Tomography Angiogram with Fractional Flow Reserve.
A Ct scan of the heart's blood vessels.
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.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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.
|
within 2 weeks after SOC assessment
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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.
|
within 2 weeks after SOC assessment
|
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
|
1 year
|
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
|
within 2 weeks after SOC assessment
|
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
|
within 2 weeks after SOC assessment
|
Collaborators and Investigators
Sponsor
Study record dates
Study Major Dates
Study Start (Anticipated)
Primary Completion (Anticipated)
Study Completion (Anticipated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 2019-151
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
product manufactured in and exported from the U.S.
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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