Cardiac Risk Assessment Using Standard of Care Versus CTA and Heart Flow FFRct (CRASCH-Liver)
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|ClinicalTrials.gov Identifier: NCT04089969|
Recruitment Status : Recruiting
First Posted : September 16, 2019
Last Update Posted : November 6, 2019
|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|
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 :||Interventional (Clinical Trial)|
|Estimated Enrollment :||100 participants|
|Intervention Model:||Sequential Assignment|
|Intervention Model Description:||Single-Blind decision-making study.|
|Masking:||None (Open Label)|
|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|
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.
- 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.
- 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.
- 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
- 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
- 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
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
|Contact: Robert Safian, MD.||(248) 898 4561||Robert.Safian@beaumont.edu|
|Contact: Diedre Brunk, MSA||(248) 898 email@example.com|
|United States, Michigan|
|William Beaumont Hospital||Recruiting|
|Royal Oak, Michigan, United States, 48073|
|Contact: Diedre Brunl, RN. MBA. 248-898-5580 firstname.lastname@example.org|
|Contact: Grace San Agustin, BSN. RN. 248 551 7835 email@example.com|
|Principal Investigator: Robert Safian, MD.|
|Principal Investigator:||Robert Safian, MD||William Beaumont Hospitals|