Ignite Creation Date:
2025-12-24 @ 1:04 PM
Ignite Modification Date:
2025-12-27 @ 9:37 PM
Study NCT ID:
NCT04219761
Status:
COMPLETED
Last Update Posted:
2022-04-04
First Post:
2020-01-05
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
National Tunisian Registry of Percutaneous Coronary Intervention
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D054058', 'term': 'Acute Coronary Syndrome'}, {'id': 'D000787', 'term': 'Angina Pectoris'}, {'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': 'D002637', 'term': 'Chest Pain'}, {'id': 'D010146', 'term': 'Pain'}, {'id': 'D009461', 'term': 'Neurologic Manifestations'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'id': 'D007238', 'term': 'Infarction'}, {'id': 'D007511', 'term': 'Ischemia'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D009336', 'term': 'Necrosis'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 2698}, 'targetDuration': '12 Months', 'patientRegistry': True}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2020-01-30', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2022-04', 'completionDateStruct': {'date': '2022-03-30', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2022-04-01', 'studyFirstSubmitDate': '2020-01-05', 'studyFirstSubmitQcDate': '2020-01-05', 'lastUpdatePostDateStruct': {'date': '2022-04-04', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2020-01-07', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2021-12-31', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'MACE endopoint (Major adverse cardiovascular event)', 'timeFrame': 'Time-To-Event measure up to 12 months from baseline', 'description': 'Composite endpoint (MACE: major adverse cardiovascular event) : occurence of cardiovascular death, or non fatal myocardial infraction, or non fatal stroke, or Target Lesion revascularisation, or Target Vessel Revascularisation'}], 'secondaryOutcomes': [{'measure': 'Death', 'timeFrame': 'Time-To-Event measure up to 12 months from baseline', 'description': 'Occurence of death incident (cardiovascular and non cardiovascular)'}, {'measure': 'PCI (Percutaneous Coronary Intervention)', 'timeFrame': 'Time-To-Event measure up to 12 months from baseline', 'description': 'PCI (Percutaneous Coronary Intervention) complications: any side effect event occuring per or post cardiac intervention'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['ACS', 'PCI', 'MI'], 'conditions': ['ACS - Acute Coronary Syndrome', 'Angor Pectoris', 'Myocardial Infarction', 'Myocardial Ischemia']}, 'referencesModule': {'references': [{'pmid': '35930353', 'type': 'DERIVED', 'citation': 'Hammami R, Boudiche S, Rami T, Ben Halima N, Jamel A, Rekik B, Gribaa R, Imtinene BM, Charfeddine S, Ellouze T, Bahloul A, Hedi BS, Langar J, Ben Ahmed H, Ibn Elhadj Z, Hmam M, Ben Abdessalem MA, Maaoui S, Fennira S, Lobna L, Hassine M, Ouanes S, Mohamed Faouzi D, Mallek S, Mahdhaoui A, Meriem D, Jomaa W, Zayed S, Kateb T, Bouchahda N, Azaiez F, Ben Salem H, Marouen M, Noamen A, Abdesselem S, Hichem D, Ibn Hadj Amor H, Abdeljelil F, Amara A, Bejar K, Khaldoun BH, Hamza C, Ben Jamaa M, Fourati S, Elleuch F, Grati Z, Chtourou S, Marouene S, Sahnoun M, Hadrich M, Mohamed Abdelkader M, Bouraoui H, Kamoun K, Hadrich M, Ben Chedli T, Drissa MA, Charfeddine H, Saadaoui N, Achraf G, Ahmed S, Ayari M, Nabil M, Mnif S, Sahnoun M, Kammoun H, Ben Jemaa K, Mostari G, Hamrouni N, Yamen M, Ellouz Y, Smiri Z, Hdiji A, Bassem J, Ayadi W, Zouari A, Abbassi C, Fatma BM, Battikh K, Kharrat E, Gtif I, Sami M, Bezdah L, Kachboura S, Maatouk MF, Kraiem S, Jeridi G, Neffati E, Kammoun S, Ben Ameur Y, Fehri W, Gamra H, Zakhama L, Addad F, Mohamed Sami M, Abid L. Design and Rationale of the National Tunisian Registry of Percutaneous Coronary Intervention: Protocol for a Prospective Multicenter Observational Study. JMIR Res Protoc. 2022 Aug 5;11(8):e24595. doi: 10.2196/24595.'}]}, 'descriptionModule': {'briefSummary': 'The National Tunisian Registry of Percutaneous Coronary Intervention is an observational, prospective and multicenter study aiming to assess coronary intervention strategies in tunisian departments of cardiology. Cardiologists from both sectors (public and private) are participating in the study, with 37 investigational centers. Data will be captured electronically by DACIMA Clinical Suite, according to FDA 21 CFR part 11 (Food and Drug Administration 21 Code of Federal Regulations part 11), HIPAA (Health Insurance Portability and Accountability Act) \\& ICH (International Conference on Harmonisation) requirements.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Tunisian patients needing percutaneous coronray intervention', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Tunisian patient needing PCI (Percutaneous Coronary Intervention) at the enrollment period\n* Informed and signed consent\n\nExclusion Criteria:\n\n* Withdrawn consent'}, 'identificationModule': {'nctId': 'NCT04219761', 'acronym': 'NATURE-PCI', 'briefTitle': 'National Tunisian Registry of Percutaneous Coronary Intervention', 'organization': {'class': 'OTHER', 'fullName': 'Dacima Consulting'}, 'officialTitle': 'National Tunisian Registry of Percutaneous Coronary Intervention', 'orgStudyIdInfo': {'id': 'DAC-009-NATUREPCI'}}, 'contactsLocationsModule': {'locations': [{'zip': '105', 'city': 'Tunis', 'country': 'Tunisia', 'facility': 'Société Tunisienne de Cardiologie & de Chirurgie Cardiovasculaire', 'geoPoint': {'lat': 36.81897, 'lon': 10.16579}}], 'overallOfficials': [{'name': 'Leila Abid, MD', 'role': 'STUDY_CHAIR', 'affiliation': 'Tunisian Society of Cardiology and Cardiovascular Surgery'}, {'name': 'Rania Hammami, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Tunisian Society of Cardiology and Cardiovascular Surgery'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Dacima Consulting', 'class': 'OTHER'}, 'collaborators': [{'name': 'Tunisian Society of Cardiology and Cardiovascular Surgery', 'class': 'OTHER'}], 'responsibleParty': {'type': 'SPONSOR'}}}}