Ignite Creation Date:
2025-12-24 @ 11:16 PM
Ignite Modification Date:
2026-01-02 @ 3:20 AM
Study NCT ID:
NCT04052256
Status:
UNKNOWN
Last Update Posted:
2022-07-27
First Post:
2019-08-08
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
The Heartflow Coronary Disease Progression Evaluation Study
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D003324', 'term': 'Coronary Artery Disease'}], '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'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 250}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2018-10-05', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2022-07', 'completionDateStruct': {'date': '2023-10-01', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2022-07-25', 'studyFirstSubmitDate': '2019-08-08', 'studyFirstSubmitQcDate': '2019-08-08', 'lastUpdatePostDateStruct': {'date': '2022-07-27', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2019-08-09', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2022-10', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Coronary atherosclerotic disease progression', 'timeFrame': '2 years', 'description': 'FFRCT'}], 'secondaryOutcomes': [{'measure': 'Target lesion failure Target vessel failure', 'timeFrame': '3-5 years', 'description': 'Composite of all-cause mortality, target-vessel myocardial infarction and cinically driven target vessel revascularization.'}, {'measure': 'Any coronary revascularisation', 'timeFrame': '3-5 years'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Fractional flow reserve', 'Coronary computed tomography angiography', 'Computational fluid dynamics', 'Plaque characteristics'], 'conditions': ['Coronary Artery Disease']}, 'descriptionModule': {'briefSummary': 'Invasively measured fractional flow reserve (FFR) has proven to be useful in guiding coronary revascularization. Several studies have shown that it is justified to treat lesions with a value of 0.80 or lower and safe to defer from PCI in lesions with a value of \\>0.80. Recently, computational fluid dynamics have allowed FFR measurement from coronary computed tomography angiography images (FFRCT) with excellent diagnostic accuracy compared to invasive FFR.\n\nFFRCT can also effectively guide revascularization safely deferring patient with FFRCT \\>0.80 from invasive angiography. In functionally non-significant lesions, computational fluid dynamic models in addition to CT plaque characteristics (low attenuation, positive remodelling, spotty calcification and napkin-ring sign) may be able to predict which lesions will become flow-limiting, causing clinical events in the future.\n\nThis study will evaluate disease progression in intermediate lesions (invasive FFR 0.81-0.90 at baseline) using FFRCT at 2 years and determine whether CT characteristics may help to identify lesions that are more susceptible for FFR decline. Additionally, we will correlate CT characteristics with coronary events (a composite endpoint consisting of all-cause mortality, target-vessel myocardial infarction and clinically driven target-vessel revascularization) up to 5 years after the baseline invasive FFR.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': 'Patients (age ≥ 18 years) treated with PCI (for non-ST elevation myocardial infarction, unstable or stable angina and silent ischemia) or who undergo invasive FFR.', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. Patients (age ≥ 18 years) treated with PCI (for non-ST elevation myocardial infarction, unstable or stable angina and silent ischemia) or who undergo invasive FFR.\n2. Minimum of one non-treated coronary artery with an intermediate lesion and invasive FFR 0.81-0.90 to serve as the target vessel for FFRCT.\n\nExclusion Criteria:\n\n1. ST elevation myocardial infarction.\n2. Previous CABG.\n3. Target vessel for FFR measurement \\< 2.0 mm in diameter.\n4. Contraindications to contrast agents, beta-blocking agents, nitroglycerin or adenosine.\n5. Life expectancy less than 3 years.\n6. Creatinine clearance \\< 30 ml/min\\*1.73m2.'}, 'identificationModule': {'nctId': 'NCT04052256', 'acronym': 'THRONE', 'briefTitle': 'The Heartflow Coronary Disease Progression Evaluation Study', 'organization': {'class': 'OTHER', 'fullName': 'Erasmus Medical Center'}, 'officialTitle': 'The Heartflow Coronary Disease Progression Evaluation Study', 'orgStudyIdInfo': {'id': 'THRONE1'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Patients with intermediate coronary lesions', 'description': 'Patients (age ≥ 18 years) who have undergone invasive coronary angiography and have a minimum of one non-treated coronary artery with a measured invasive FFR of 0.81-0.90.', 'interventionNames': ['Diagnostic Test: Coronary computed tomography angiography']}], 'interventions': [{'name': 'Coronary computed tomography angiography', 'type': 'DIAGNOSTIC_TEST', 'description': 'Computational fluid dynamic model information derived from CT', 'armGroupLabels': ['Patients with intermediate coronary lesions']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Rotterdam', 'status': 'RECRUITING', 'country': 'Netherlands', 'contacts': [{'name': 'Admir Dedic, MD, PhD', 'role': 'CONTACT', 'email': 'a.dedic@erasmusmc.nl', 'phone': '00311070438894'}, {'name': 'Nicolas van Mieghem, MD, PhD', 'role': 'PRINCIPAL_INVESTIGATOR'}, {'name': 'Admir Dedic, MD, PhD', 'role': 'SUB_INVESTIGATOR'}], 'facility': 'Erasmus MC', 'geoPoint': {'lat': 51.9225, 'lon': 4.47917}}], 'centralContacts': [{'name': 'Nicolas van Mieghem, MD, PhD', 'role': 'CONTACT', 'email': 'n.vanmieghem@erasmusmc.nl', 'phone': '00311070438894'}, {'name': 'Admir Dedic, MD, PhD', 'role': 'CONTACT', 'email': 'a.dedic@erasmusmc.nl', 'phone': '00311070438894'}], 'overallOfficials': [{'name': 'Jonathan A Leipsic, MD, PhD', 'role': 'STUDY_CHAIR', 'affiliation': 'University of British Columbia'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Erasmus Medical Center', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Director of Interventional Cardiology', 'investigatorFullName': 'Nicolas van Mieghem', 'investigatorAffiliation': 'Erasmus Medical Center'}}}}