Ignite Creation Date:
2025-12-25 @ 1:07 AM
Ignite Modification Date:
2025-12-25 @ 11:19 PM
Study NCT ID:
NCT06565793
Status:
NOT_YET_RECRUITING
Last Update Posted:
2024-12-27
First Post:
2024-08-11
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
A MAajor RAdiation-based PCI Study in STEMI and NSTEMI
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D009203', 'term': 'Myocardial Infarction'}, {'id': 'D011832', 'term': 'Radiation Injuries'}, {'id': 'D023921', 'term': 'Coronary Stenosis'}, {'id': 'D003328', 'term': 'Coronary Thrombosis'}, {'id': 'D054059', 'term': 'Coronary Occlusion'}, {'id': 'D000789', 'term': 'Angina, Unstable'}, {'id': 'D003324', 'term': 'Coronary Artery Disease'}], 'ancestors': [{'id': 'D017202', 'term': 'Myocardial Ischemia'}, {'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'}, {'id': 'D014947', 'term': 'Wounds and Injuries'}, {'id': 'D003327', 'term': 'Coronary Disease'}, {'id': 'D013927', 'term': 'Thrombosis'}, {'id': 'D016769', 'term': 'Embolism and Thrombosis'}, {'id': 'D000787', 'term': 'Angina Pectoris'}, {'id': 'D002637', 'term': 'Chest Pain'}, {'id': 'D010146', 'term': 'Pain'}, {'id': 'D009461', 'term': 'Neurologic Manifestations'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D001161', 'term': 'Arteriosclerosis'}, {'id': 'D001157', 'term': 'Arterial Occlusive Diseases'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 15630}, 'targetDuration': '5 Years', 'patientRegistry': True}, 'statusModule': {'overallStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2025-03-01', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-12', 'completionDateStruct': {'date': '2025-12-31', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2024-12-21', 'studyFirstSubmitDate': '2024-08-11', 'studyFirstSubmitQcDate': '2024-08-21', 'lastUpdatePostDateStruct': {'date': '2024-12-27', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2024-08-22', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2025-07-01', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Death', 'timeFrame': '30 days', 'description': 'The primary end point of the study is the rate of death'}, {'measure': 'Death', 'timeFrame': '1 year', 'description': 'The primary end point of the study is the rate of death'}, {'measure': 'Death', 'timeFrame': '5 years', 'description': 'The primary end point of the study is the rate of death'}, {'measure': 'Myocardial Infarction', 'timeFrame': '30 days', 'description': 'The primary end point of the study is the rate of myocardial infarction'}, {'measure': 'Myocardial Infarction', 'timeFrame': '1 year', 'description': 'The primary end point of the study is the rate of myocardial infarction'}, {'measure': 'Myocardial Infarction', 'timeFrame': '5 years', 'description': 'The primary end point of the study is the rate of myocardial infarction'}, {'measure': 'Stent Thrombosis', 'timeFrame': '30 days', 'description': 'The primary end point of the study is the rate of stent thrombosis'}, {'measure': 'Stent Thrombosis', 'timeFrame': '1 year', 'description': 'The primary end point of the study is the rate of stent thrombosis'}, {'measure': 'Stent Thrombosis', 'timeFrame': '5 years', 'description': 'The primary end point of the study is the rate of stent thrombosis'}, {'measure': 'Acute Kidney Injury', 'timeFrame': '30 days', 'description': 'The primary end point of the study is the rate of acute kidney injury'}, {'measure': 'Acute Kidney Injury', 'timeFrame': '1 years', 'description': 'The primary end point of the study is the rate of acute kidney injury'}, {'measure': 'Coronary Obstruction Requiring Intervention', 'timeFrame': '30 days', 'description': 'The primary end point of the study is the rate of coronary obstruction requiring intervention'}, {'measure': 'Coronary Obstruction Requiring Intervention', 'timeFrame': '1 year', 'description': 'The primary end point of the study is the rate of coronary obstruction requiring intervention'}, {'measure': 'Coronary Obstruction Requiring Intervention', 'timeFrame': '5 years', 'description': 'The primary end point of the study is the rate of coronary obstruction requiring intervention'}, {'measure': 'Increase in Tnl and Tnt Levels', 'timeFrame': '30 days', 'description': 'The primary end point of the study is the rate in increase of Tnl and Tnt levels'}, {'measure': 'Increase in Tnl and Tnt Levels', 'timeFrame': '1 year', 'description': 'The primary end point of the study is the rate in increase of Tnl and Tnt levels'}, {'measure': 'Rehospitalization', 'timeFrame': '30 days', 'description': 'The primary end point of the study is the rate of rehospitalization (coronary-related or procedure-related, including heart failure)'}, {'measure': 'Rehospitalization', 'timeFrame': '1 year', 'description': 'The primary end point of the study is the rate of rehospitalization (coronary-related or procedure-related, including heart failure)'}, {'measure': 'Rehospitalization', 'timeFrame': '5 years', 'description': 'The primary end point of the study is the rate of rehospitalization (coronary-related or procedure-related, including heart failure)'}], 'secondaryOutcomes': [{'measure': 'Target Vessel Revascularization', 'timeFrame': '1 year', 'description': 'The secondary end point of the study is the rate of target vessel revascularization'}, {'measure': 'Target Vessel Revascularization', 'timeFrame': '5 years', 'description': 'The secondary end point of the study is the rate of target vessel revascularization'}, {'measure': 'Target Lesion Revascularization', 'timeFrame': '1 year', 'description': 'The secondary end point of the study is the rate of target lesion revascularization'}, {'measure': 'Target Lesion Revascularization', 'timeFrame': '5 years', 'description': 'The secondary end point of the study is the rate of target lesion revascularization'}]}, 'oversightModule': {'isUsExport': True, 'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': True}, 'conditionsModule': {'keywords': ['PCI,DES, Radiation'], 'conditions': ['Myocardial Infarction (MI)', 'Radiation Toxicity', 'Coronary Stenosis', 'Coronary Thrombosis', 'Coronary Artery Calcification', 'Coronary Occlusion', 'Coronary Syndrome', 'Coronary Artery Disease']}, 'descriptionModule': {'briefSummary': 'In France and Italy, approximately 240,000 percutaneous coronary angioplasties (PCI) are performed annually, with an increasing number of complex procedures, including those involving the left coronary common trunk, a bifurcation, chronic occlusion, or requiring Rotablator Rotary Atherectomy (ARota). The medical literature lacks sufficient data regarding several key aspects of complex angioplasty. These include the epidemiological characteristics of patients undergoing such procedures, the impact of irradiation delivered and the quantity of iodine injected on these lengthy procedures, their procedural complication rate, and in-hospital mortality.', 'detailedDescription': 'A retrospective database of the hemodynamics department of the Centre Cardiologique du Nord and Clinica Mediterranea, comprising 15,630 consecutive angioplasties performed in unselected patients between February 1, 2008, and July 7, 2018, was used to identify complex angioplasties and standard angioplasties. Two categories of complex angioplasty were identified: complex angioplasty with a single complexity criterion and very complex angioplasty with two or more complexity criteria. These complex angioplasties were then compared with standard angioplasty (angioplasty with no complexity criteria).\n\nThe following criteria were employed to delineate complex or very complex angioplasties:\n\n* Unprotected Left Coronary Common Trunk Angioplasty (UT-PCI)\n* Angioplasty with Rotablator Rotary Atherectomy (ARota-PCI)\n* Angioplasty of Chronic Coronary Occlusion (CCO-PCI)\n* Angioplasty of a Bifurcation Lesion (CBL-PCI)\n\nThe following definitions pertain to the classification of angioplasty procedures:\n\n* Standard angioplasty: This encompasses angioplasty procedures that do not meet the criteria for complexity.\n* Complex angioplasty: This designation is applied to angioplasty procedures that meet at least one criterion for complexity.\n* Very complex angioplasty: This designation is applied to angioplasty procedures that meet at least two criteria for complexity.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '90 Years', 'minimumAge': '18 Years', 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': '* Standard angioplasty: This encompasses angioplasty procedures that do not meet the criteria for complexity.\n* Complex angioplasty: This designation is applied to angioplasty procedures that meet at least one criterion for complexity.\n* Very complex angioplasty: This designation is applied to angioplasty procedures that meet at least two criteria for complexity.', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* The patient presents with a STEMI or NSTEMI requiring either a non-complex or complex PCI.\n\nExclusion Criteria:\n\n\\-'}, 'identificationModule': {'nctId': 'NCT06565793', 'acronym': 'MARAA', 'briefTitle': 'A MAajor RAdiation-based PCI Study in STEMI and NSTEMI', 'organization': {'class': 'OTHER', 'fullName': 'Centre Cardiologique du Nord'}, 'officialTitle': 'The Impact of Radiation Delivered to the Patient and the Amount of Iodinated Contrast Medium Injected in Complex Versus Noncomplex Percutaneous Coronary Intervention.', 'orgStudyIdInfo': {'id': 'ID: CN-08-24'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Non Complex PCI', 'description': 'The objective of this study is to examine the efficacy of percutaneous coronary intervention (PCI) with the use of drug-eluting stents (DES) in patients diagnosed with ST-Elevation Myocardial Infarction (STEMI) or Non-ST-Elevation Myocardial Infarction (NSTEMI).', 'interventionNames': ['Device: Non Complex PCI']}, {'label': 'Complex PCI', 'description': 'This study focuses on patients diagnosed with either STEMI or NSTEMI who have undergone complex percutaneous coronary intervention (PCI) with the use of drug-eluting stents (DES).The following criteria were used to distinguish between complex and very complex angioplasty cases:\n\nThe following procedures have been identified as complex or very complex:\n\n* Unprotected Left Coronary Common Trunk Angioplasty (UT-PCI)\n* Angioplasty with Rotablator Rotary Atherectomy (ARota-PCI)\n* Angioplasty of Chronic Coronary Occlusion (CCO-PCI)', 'interventionNames': ['Device: Complex PCI']}], 'interventions': [{'name': 'Non Complex PCI', 'type': 'DEVICE', 'description': 'The patient cohort included individuals who had been hospitalized with a diagnosis of either STEMI or non-STEMI. The procedure involved percutaneous coronary intervention (PCI) with the use of drug-eluting stents (DES).', 'armGroupLabels': ['Non Complex PCI']}, {'name': 'Complex PCI', 'type': 'DEVICE', 'description': 'The patient cohort included individuals who had been hospitalized with a diagnosis of either STEMI or non-STEMI. The procedure involved complex percutaneous coronary intervention (PCI) with the use of drug-eluting stents (DES).This designation is applied to angioplasty procedures that meet at least one criterion for complexity. The complex angioplasty involved patients with unprotected left coronary common trunk (UT-PCI), the use of rotablator rotary atherectomy (ARota-PCI), the angioplasty of chronic coronary occlusion (CCO-PCI), or the angioplasty of a bifurcation lesion (CBL-PCI).The highly intricate angioplasty procedure was conducted on patients who met at least two criteria indicative of complexity.', 'armGroupLabels': ['Complex PCI']}]}, 'contactsLocationsModule': {'centralContacts': [{'name': 'Francesco Nappi, MD', 'role': 'CONTACT', 'email': 'francesconappi2@gmail.com', 'phone': '782298823', 'phoneExt': '+33'}, {'name': 'Francesco Nappi, MD', 'role': 'CONTACT', 'email': 'francesconappi2@gmail.com', 'phone': '49334119', 'phoneExt': '+33'}], 'overallOfficials': [{'name': 'Francesco Nappi, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Centre Cardiologique du Nord'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Centre Cardiologique du Nord', 'class': 'OTHER'}, 'collaborators': [{'name': 'Clinica Mediterranea', 'class': 'OTHER'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Consultan', 'investigatorFullName': 'Francesco Nappi', 'investigatorAffiliation': 'Centre Cardiologique du Nord'}}}}