Ignite Creation Date:
2025-12-24 @ 10:57 PM
Ignite Modification Date:
2026-02-13 @ 11:47 AM
Study NCT ID:
NCT04089969
Status:
WITHDRAWN
Last Update Posted:
2023-03-02
First Post:
2019-09-12
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Cardiac Risk Assessment Using Standard of Care Versus CTA and Heart Flow FFRct
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24', 'removedCountries': ['United States']}, 'conditionBrowseModule': {'meshes': [{'id': 'D003324', 'term': 'Coronary Artery Disease'}, {'id': 'D017114', 'term': 'Liver Failure, Acute'}, {'id': 'D058625', 'term': 'End Stage Liver Disease'}, {'id': 'D017093', 'term': 'Liver Failure'}], 'ancestors': [{'id': 'D003327', 'term': 'Coronary Disease'}, {'id': 'D017202', 'term': 'Myocardial Ischemia'}, {'id': 'D006331', 'term': 'Heart Diseases'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}, {'id': 'D001161', 'term': 'Arteriosclerosis'}, {'id': 'D001157', 'term': 'Arterial Occlusive Diseases'}, {'id': 'D014652', 'term': 'Vascular Diseases'}, {'id': 'D048550', 'term': 'Hepatic Insufficiency'}, {'id': 'D008107', 'term': 'Liver Diseases'}, {'id': 'D004066', 'term': 'Digestive System Diseases'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'DIAGNOSTIC', 'interventionModel': 'SEQUENTIAL', 'interventionModelDescription': 'Single-Blind decision-making study.'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 0}}, 'statusModule': {'whyStopped': 'Essential staff for study execution left the institution and no suitable replacement could be found.', 'overallStatus': 'WITHDRAWN', 'startDateStruct': {'date': '2023-06', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-02', 'completionDateStruct': {'date': '2024-06', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2023-02-28', 'studyFirstSubmitDate': '2019-09-12', 'studyFirstSubmitQcDate': '2019-09-12', 'lastUpdatePostDateStruct': {'date': '2023-03-02', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2019-09-16', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2024-06', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Change in clinical recommendation', 'timeFrame': 'within 2 weeks after SOC assessment', 'description': 'Number of Participants whose clinical recommendation as initially determined by SOC assessment is changed following CTA/FFRct assessment.'}], 'secondaryOutcomes': [{'measure': 'Frequency of detecting Coronary Artery Disease (CAD) by CTA/FFRct', 'timeFrame': 'within 2 weeks after SOC assessment', 'description': 'Number of Participants with agreement in CAD status detected by both Pharmacological stress test and also CTA/FFRct.'}, {'measure': 'Cardiovascular morbidity', 'timeFrame': '1 year', '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'}, {'measure': 'Projected Health Care Cost', 'timeFrame': 'within 2 weeks after SOC assessment', 'description': 'Dollar value of Standard of care treatment (related to CAD) and CTA/FFRct'}, {'measure': 'Frequency of Detecting Myocardial Ischemia and the frequency of detecting the correct territory of the Myocardial Ischemia.', 'timeFrame': 'within 2 weeks after SOC assessment', 'description': 'Number of participants with Myocardial Ischemia and correct territory of Myocardial Ischemia detected by Pharmacological Stress Test vs CTA/FFRct'}]}, 'oversightModule': {'isUsExport': True, 'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': True}, 'conditionsModule': {'keywords': ['CTA, FFRct, CAD', 'End Stage Liver DIsease', 'Liver failure, Liver transplant'], 'conditions': ['Coronary Artery Disease', 'Acute Liver Failure', 'Liver Transplant']}, 'descriptionModule': {'briefSummary': '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.', 'detailedDescription': '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.\n\nAll 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.\n\nThe 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).'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. Patients with end-stage liver disease\n2. Patients undergoing cardiovascular risk assessment prior to liver transplantation -\n\nExclusion Criteria:\n\n1. Estimated Glomerular Filtration Rate (eGFR) \\< 30 cc/min/1.73 m\\^2 (unless patient is on dialysis or renal transplant is planned)\n2. Heart rate \\> 90 bpm despite beta blocker therapy\n3. Body Mass Index (BMI) \\> 40 plus chest obesity (i.e. truncal obesity and normal chest morphology is not an exclusion)\n4. Pregnant Women'}, 'identificationModule': {'nctId': 'NCT04089969', 'acronym': 'CRASCH-Liver', 'briefTitle': 'Cardiac Risk Assessment Using Standard of Care Versus CTA and Heart Flow FFRct', 'organization': {'class': 'OTHER', 'fullName': 'Corewell Health East'}, 'officialTitle': '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.', 'orgStudyIdInfo': {'id': '2019-151'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Evaluation of Standard of care followed by CTA/FFRct', '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', 'interventionNames': ['Diagnostic Test: CTA/FFRct', 'Diagnostic Test: SOC cardiovascular evaluation']}], 'interventions': [{'name': 'CTA/FFRct', 'type': 'DIAGNOSTIC_TEST', 'description': "Computed Tomography Angiogram with Fractional Flow Reserve. A Ct scan of the heart's blood vessels.", 'armGroupLabels': ['Evaluation of Standard of care followed by CTA/FFRct']}, {'name': 'SOC cardiovascular evaluation', 'type': 'DIAGNOSTIC_TEST', '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.', 'armGroupLabels': ['Evaluation of Standard of care followed by CTA/FFRct']}]}, 'contactsLocationsModule': {'overallOfficials': [{'name': 'Robert Safian, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Corewell Health East'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Corewell Health East', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'MD.', 'investigatorFullName': 'Robert Safian', 'investigatorAffiliation': 'Corewell Health East'}}}}