Ignite Creation Date:
2025-12-25 @ 2:59 AM
Ignite Modification Date:
2026-01-07 @ 11:35 AM
Study NCT ID:
NCT06486233
Status:
RECRUITING
Last Update Posted:
2024-07-03
First Post:
2024-06-12
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Studying the Effectiveness of Early Invasive Treatment in Elderly Patients With High-risk Non-ST-segment Elevation Acute Coronary Syndrome.
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D009203', 'term': 'Myocardial Infarction'}], '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'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 385}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2024-02-22', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-06', 'completionDateStruct': {'date': '2028-03-01', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2024-06-26', 'studyFirstSubmitDate': '2024-06-12', 'studyFirstSubmitQcDate': '2024-06-26', 'lastUpdatePostDateStruct': {'date': '2024-07-03', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2024-07-03', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2026-03-01', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'In-hospital death', 'timeFrame': 'one month', 'description': 'recorded when death occurs during treatment or is confirmed by in-hospital monitoring'}], 'secondaryOutcomes': [{'measure': 'after 12 months death', 'timeFrame': 'one year', 'description': 'determined by the patient follow-up period from hospital discharge until results were recorded'}, {'measure': 'MACE after 12 months include re-admission, recurrent myocardial infarction , stroke, heart failure', 'timeFrame': 'one year', 'description': 'recorded'}]}, 'oversightModule': {'isUsExport': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['percutaneous coronary intervention, elderly, non-ST-segment Elevation'], 'conditions': ['Myocardial Infarction']}, 'descriptionModule': {'briefSummary': 'The goal of this is observational study is to compare about MACE events and predisposing factors related to MACE events in elderly patients with high-risk non-ST acute coronary syndromes receiving early versus late invasive treatment . This study will anwser two questions.\n\nQuestion 1: What will factors associate with implementing a late invasive strategy in elderly patients with high-risk non-ST-segment elevation acute coronary syndrome ? Question 2: Is a meaningful difference about mortality and complication rates as re-myocardial infarction, heart failure, re-hospitalization, stroke after 12 months between two groups of patients undergoing early invasive and late invasive strategies in elderly patients with in high-risk non-ST-segment elevation acute coronary syndrome?'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '60 Years', 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': "All patients aged 60 years and older were diagnosed with non-ST elevation acute coronary syndrome. Diagnosed with high-risk acute non-ST elevation syndrome and treated at Gia Dinh People's Hospital, Thong Nhat Hospital during the study period.", 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* aged 60 years and older\n* high - risk non-ST-segment elevation acute coronary syndrome (according to the 2023 European Heart Association recommended standards).\n* receives reperfusion intervention.\n\nExclusion Criteria:\n\n* Acute coronary syndrome due to stent thrombosis, or coronary artery bypass graft occlusion.\n* Incomplete medical records.'}, 'identificationModule': {'nctId': 'NCT06486233', 'briefTitle': 'Studying the Effectiveness of Early Invasive Treatment in Elderly Patients With High-risk Non-ST-segment Elevation Acute Coronary Syndrome.', 'organization': {'class': 'OTHER', 'fullName': 'Gia Dinh People Hospital'}, 'officialTitle': 'Comparison of Mortality and Complication Rates (Re-myocardial Infarction, Heart Failure, Re-hospitalization, Stroke) After 12 Months Between Two Groups of Patients Undergoing Early Invasive and Late Invasive Strategies in Patients With Elderly Patients With High - Risk Non-ST-segment Elevation Acute Coronary Syndrome.', 'orgStudyIdInfo': {'id': '329/HDDD-DHYD'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Observe the patient with early percutaneous coronary intervention', 'description': 'Elderly patients with non-ST-segment elevation acute coronary syndrome receive early percutaneous coronary intervention (\\< 24 hours after diagnosis).'}, {'label': 'Observe the patient with late percutaneous coronary intervention', 'description': 'Elderly patients with non-ST elevation acute coronary syndrome undergoing late percutaneous coronary intervention (≥ 24 hours after diagnosis)'}]}, 'contactsLocationsModule': {'locations': [{'city': 'Ho Chi Minh City', 'status': 'RECRUITING', 'country': 'Vietnam', 'contacts': [{'name': 'Sang Thanh Nguyen, 35', 'role': 'CONTACT', 'email': 'drsangthanhnguyen@gmail.com', 'phone': '0902489252'}], 'facility': 'Gia Dinh people hospital', 'geoPoint': {'lat': 10.82302, 'lon': 106.62965}}], 'centralContacts': [{'name': 'Sang Thanh Nguyen, Doctor', 'role': 'CONTACT', 'email': 'drsangthanhnguyen@gmail.com', 'phone': '+84902489252'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Gia Dinh People Hospital', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}