Ignite Creation Date:
2025-12-25 @ 4:48 AM
Ignite Modification Date:
2025-12-26 @ 3:50 AM
Study NCT ID:
NCT04818918
Status:
RECRUITING
Last Update Posted:
2024-02-01
First Post:
2021-03-24
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Coronary Flow and Myocardial Viability: the FloVITA Study
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D009203', 'term': 'Myocardial Infarction'}, {'id': 'D017202', 'term': 'Myocardial Ischemia'}], 'ancestors': [{'id': 'D006331', 'term': 'Heart Diseases'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}, {'id': 'D014652', 'term': 'Vascular Diseases'}, {'id': 'D007238', 'term': 'Infarction'}, {'id': 'D007511', 'term': 'Ischemia'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'id': 'D009336', 'term': 'Necrosis'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 45}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2021-05-19', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-01', 'completionDateStruct': {'date': '2024-08-20', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2024-01-31', 'studyFirstSubmitDate': '2021-03-24', 'studyFirstSubmitQcDate': '2021-03-24', 'lastUpdatePostDateStruct': {'date': '2024-02-01', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2021-03-26', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2024-08-20', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Coronary flow (mL/min) in the LAD', 'timeFrame': 'At the end of the angiography procedure', 'description': 'Measurement of coronary flow in mL/min in the left anterior descending artery'}], 'secondaryOutcomes': [{'measure': 'Microvascular resistance', 'timeFrame': 'At the end of the angiography procedure', 'description': 'Measurement of microvascular resistance in the LAD'}, {'measure': 'Myocardial necrosis', 'timeFrame': 'Cardiac MRI to be performed 7 to 30 days after index angiography procedure', 'description': 'Extent of myocardial necrosis on cardiac MRI (number of segments)'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['microvascular resistance', 'fractional flow reserve', 'myocardial viability'], 'conditions': ['Myocardial Infarction', 'Myocardial Ischemia']}, 'referencesModule': {'references': [{'pmid': '41078218', 'type': 'DERIVED', 'citation': 'Guillon B, Besutti M, Revel L, Seronde MF, Meneveau N, Chopard R. Absolute Coronary Flow Reduction Mediated by Microvascular Resistance in Myocardial Infarction: The FLOVITA Study. Catheter Cardiovasc Interv. 2025 Dec;106(7):3588-3596. doi: 10.1002/ccd.70268. Epub 2025 Oct 13.'}]}, 'descriptionModule': {'briefSummary': 'Evaluation of fractional flow reserve (FFR) is a key method for assessing ischemia with a view to guiding revascularization strategy following acute coronary syndrome. A stenosis that appears to be severe by angiography may cause limited ischemia (with an FFR value \\>0.80) due to the incapacity of the necrotic zone to achieve physiological hyperemia, i.e. maximal coronary flow. Recently, it has been demonstrated that absolute coronary flow, and micro- and macrovascular resistance, as measured by a thermodilution technique, using the Rayflow microcatheter (Hexacath) are strongly associated with myocardial mass. In extensive necrosis, there is a loss of myocardial mass, and these tools could be of potential interest in measuring myocardial viability, which reflects the extent of remaining viable myocardial mass.\n\nTherefore, this study aims to investigate the relationship between both absolute coronary flow and microvascular resistance, and myocardial viability assessed by MRI.\n\nIn a prospective, single-centre, interventional study, we will compare absolute coronary flow and microvascular resistance in the left anterior descending artery, in patients with and without a history of ST segment elevation MI.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '80 Years', 'minimumAge': '18 Years', 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': 'Patients with recent (\\>=7 days) ST segment elevation MI for the intervention group, and patients with stable angina or silent ischemia for the control group.', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Inclusion criteria for the STEMI group:\n\n * ST segment elevation MI ≥7 days treated by angioplasty of the left anterior descending (LAD) artery\n * Scheduled to undergo angiography for fractional flow reserve (FFR) assessment of a lesion other than the infarct-related artery.\n* Inclusion criteria for the control group:\n\n * patients undergoing non-urgent coronary angiography for stable angina or silent ischemia\n * with measure of the FFR on one or more vessels (intermediate lesion \\<90% without proven ischemia)\n* absence of any significant lesion on the LAD (as assessed by angiography or FFR\\>0.8)\n* Inclusion criteria for both groups:\n\n * Written informed consent\n * Affiliation to a social security regimen (or beneficiary thereof).\n\nExclusion Criteria:\n\n* Target vessel (LAD) not permeable.\n* FFR \\<0.8 in the LAD\n* Coronary spasm\n* Left ventricular ejection fraction \\<0.50 or a history of anterior MI in patients in the control group\n* Hypertrophic cardiomyopathy\n* Severe valvular heart disease\n* History of coronary artery bypass graft\n* Patients with limited legal capacity or patients under guardianship/tutorship\n* Patients with anticipated poor compliance as assessed by the investigator\n* Patients not affiliated to any social security regime.\n* Pregnant women.\n* Subjects within the exclusion period of another clinical trial as noted in the national registry of research volunteers'}, 'identificationModule': {'nctId': 'NCT04818918', 'acronym': 'FloVita', 'briefTitle': 'Coronary Flow and Myocardial Viability: the FloVITA Study', 'organization': {'class': 'OTHER', 'fullName': 'Centre Hospitalier Universitaire de Besancon'}, 'officialTitle': 'Study of the Relationship Between Coronary Flow and Myocardial Viability: the Single-centre, Observational, Prospective FloVITA Study', 'orgStudyIdInfo': {'id': '2020-0123456'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'STEMI group', 'description': 'Patients with anterior ST segment MI treated with percutaneous coronary intervention of the left anterior descending artery, at least 7 days prior to inclusion, and scheduled for new angiography to evaluate FFR of a lesion other than the infarct-related artery.\n\nAbsolute coronary flow and microvascular resistance will be measured in the LAD.', 'interventionNames': ['Device: Absolute coronary flow measurement', 'Device: Microvascular resistance measurement', 'Other: Cardiac MRI']}, {'label': 'Control group', 'description': 'Patients undergoing non-urgent coronary angiography for stable angina or silent ischemia, with measure of FFR on one or more vessels (intermediate lesions \\<90% without proven ischemia). Absence of any signfiicant lesion on the left anterior descending artery (as evaluated by angiography or FFR value \\>0.8).\n\nAbsolute coronary flow and microvascular resistance will be measured in the LAD.', 'interventionNames': ['Device: Absolute coronary flow measurement', 'Device: Microvascular resistance measurement']}], 'interventions': [{'name': 'Absolute coronary flow measurement', 'type': 'DEVICE', 'description': 'Absolute coronary flow will be measured.', 'armGroupLabels': ['Control group', 'STEMI group']}, {'name': 'Microvascular resistance measurement', 'type': 'DEVICE', 'description': 'Microvascular resistance will be measured.', 'armGroupLabels': ['Control group', 'STEMI group']}, {'name': 'Cardiac MRI', 'type': 'OTHER', 'description': 'Cardiac MRI will be performed to evaluate myocardial viability.', 'armGroupLabels': ['STEMI group']}]}, 'contactsLocationsModule': {'locations': [{'zip': '25000', 'city': 'Besançon', 'status': 'RECRUITING', 'country': 'France', 'contacts': [{'name': 'Benoit Guillont, MD', 'role': 'CONTACT', 'email': 'benoit.guillon@univ-fcomte.fr'}], 'facility': 'CHU Besancon', 'geoPoint': {'lat': 47.24878, 'lon': 6.01815}}], 'centralContacts': [{'name': 'Benoit Guillon, MD', 'role': 'CONTACT', 'email': 'benoit.guillon@univ-fcomte.fr', 'phone': '33381668185'}], 'overallOfficials': [{'name': 'Nicolas Meneveau, MD, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Centre Hospitalier Universitaire de Besancon'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Centre Hospitalier Universitaire de Besancon', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}