Ignite Creation Date:
2025-12-25 @ 3:53 AM
Ignite Modification Date:
2026-03-02 @ 6:44 PM
Study NCT ID:
NCT02806102
Status:
UNKNOWN
Last Update Posted:
2016-07-06
First Post:
2016-05-31
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
CardiOvascular Risk and idEntificAtion of Potential High-risk Population in Acute Myocardial Infarction II (COREA-AMI II)
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D006470', 'term': 'Hemorrhage'}], 'ancestors': [{'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D062645', 'term': 'Percutaneous Coronary Intervention'}], 'ancestors': [{'id': 'D057510', 'term': 'Endovascular Procedures'}, {'id': 'D014656', 'term': 'Vascular Surgical Procedures'}, {'id': 'D013504', 'term': 'Cardiovascular Surgical Procedures'}, {'id': 'D013514', 'term': 'Surgical Procedures, Operative'}, {'id': 'D019060', 'term': 'Minimally Invasive Surgical Procedures'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 13000}, 'targetDuration': '5 Years', 'patientRegistry': True}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2004-01'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2016-07', 'completionDateStruct': {'date': '2018-02', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2016-07-03', 'studyFirstSubmitDate': '2016-05-31', 'studyFirstSubmitQcDate': '2016-06-15', 'lastUpdatePostDateStruct': {'date': '2016-07-06', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2016-06-20', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2017-02', 'type': 'ESTIMATED'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'Cumulative incidence of cardiovascular events beyond first year after percutaneous coronary intervention', 'timeFrame': 'From 1 year up to 5 years after percutaneous coronary intervention', 'description': 'Cardiac death, nonfatal myocardial infarction, or nonfatal stroke'}], 'primaryOutcomes': [{'measure': 'Cumulative incidence of cardiovascular events', 'timeFrame': '5 years', 'description': 'Cardiac death, nonfatal myocardial infarction, or nonfatal stroke'}], 'secondaryOutcomes': [{'measure': 'Cumulative incidence of all-cause death', 'timeFrame': '5 years'}, {'measure': 'Cumulative incidence of cardiac death', 'timeFrame': '5 years'}, {'measure': 'Cumulative incidence of nonfatal myocardial infarction', 'timeFrame': '5 years'}, {'measure': 'Cumulative incidence of nonfatal stroke', 'timeFrame': '5 years'}, {'measure': 'Cumulative incidence of target lesion revascularization', 'timeFrame': '5 years'}, {'measure': 'Cumulative incidence of target vessel revascularization', 'timeFrame': '5 years'}, {'measure': 'Cumulative incidence of non-target vessel revascularization', 'timeFrame': '5 years'}, {'measure': 'Cumulative incidence of definite/Probable stent thrombosis', 'timeFrame': '5 years'}, {'measure': 'Cumulative incidence of hospitalization for heart failure', 'timeFrame': '5 years'}, {'measure': 'Cumulative incidence of bleeding defined as the Bleeding Academic Research Consortium definitions type 2, 3, and 5', 'timeFrame': '5 years'}, {'measure': 'Bleeding defined as the thrombolysis In Myocardial Infarction major/minor', 'timeFrame': '5 years'}, {'measure': 'Cumulative incidence of major adverse cardiac and cerebrovascular events', 'timeFrame': '5 years', 'description': 'All-cause death, nonfatal myocardial infarction, nonfatal stroke, or any revascularization'}]}, 'conditionsModule': {'conditions': ['Acute Myocardial Infarction', 'Percutaneous Coronary Intervention', 'Major Adverse Cardiovascular Events', 'Bleeding']}, 'referencesModule': {'references': [{'pmid': '41299333', 'type': 'DERIVED', 'citation': 'Kim SH, Choo EH, Kang J, Lee JM, Yoo KD, Park MW, Park CS, Kim HY, Kim MC, Ahn Y, Chang K, Kim HS. The efficacy and safety of prasugrel in acute coronary syndrome: a propensity-matched Korean cohort study focused on age and weight of patients. BMC Cardiovasc Disord. 2025 Nov 26. doi: 10.1186/s12872-025-05263-w. Online ahead of print.'}, {'pmid': '41293617', 'type': 'DERIVED', 'citation': 'Kim S, Lee KY, Kim KA, Byeon J, Shin S, Hwang BH, Kim JJ, Choo EH, Kim CJ, Kyoung Sa Y, Park MW, Hyun S, Yoon AH, Ahn Y, Chang K. The role of serum uric acid in survival prediction in patients with acute myocardial infarction accompanied by heart failure with preserved ejection fraction. Front Cardiovasc Med. 2025 Nov 10;12:1622275. doi: 10.3389/fcvm.2025.1622275. eCollection 2025.'}, {'pmid': '39158557', 'type': 'DERIVED', 'citation': 'Kim KA, Kim SH, Lee KY, Yoon AH, Hwang BH, Choo EH, Kim JJ, Choi IJ, Kim CJ, Lim S, Park MW, Yoo KD, Jeon DS, Ahn Y, Jeong MH, Chang K. Predictors and Long-Term Clinical Impact of Heart Failure With Improved Ejection Fraction After Acute Myocardial Infarction. J Am Heart Assoc. 2024 Aug 20;13(16):e034920. doi: 10.1161/JAHA.124.034920. Epub 2024 Aug 19.'}, {'pmid': '37493020', 'type': 'DERIVED', 'citation': 'Lee M, Lee K, Kim DW, Cho JS, Kim TS, Kwon J, Kim CJ, Park CS, Kim HY, Yoo KD, Jeon DS, Chang K, Kim MC, Jeong MH, Ahn Y, Park MW. Comparative Effectiveness of Long-Term Maintenance Beta-Blocker Therapy After Acute Myocardial Infarction in Stable, Optimally Treated Patients Undergoing Percutaneous Coronary Intervention. J Am Heart Assoc. 2023 Aug;12(15):e028976. doi: 10.1161/JAHA.122.028976. Epub 2023 Jul 26.'}, {'pmid': '37019077', 'type': 'DERIVED', 'citation': 'Kim HY, Mok J, Kim JY, Jeon D, Her SH, Park MW, Kim DB, Park CS, Lee JM, Chang K, Jung WS, Ahn Y. Effect of Angiotensin Receptor Blocker Dose in Myocardial Infarction With Preserved Left Ventricular Systolic Function. J Cardiovasc Pharmacol. 2023 Jul 1;82(1):52-60. doi: 10.1097/FJC.0000000000001427.'}, {'pmid': '36346059', 'type': 'DERIVED', 'citation': 'Ahn Y, Lee D, Choo EH, Choi IJ, Lim S, Lee KY, Hwang BH, Park MW, Lee JM, Park CS, Kim HY, Yoo KD, Jeon DS, Chung WS, Kim MC, Jeong MH, Ahn Y, Chang K. Association Between Bleeding and New Cancer Detection and the Prognosis in Patients With Myocardial Infarction. J Am Heart Assoc. 2022 Nov 15;11(22):e026588. doi: 10.1161/JAHA.122.026588. Epub 2022 Nov 8.'}, {'pmid': '36000434', 'type': 'DERIVED', 'citation': 'Cho KH, Kim MC, Choo EH, Choi IJ, Lee SN, Park MW, Park CS, Kim HY, Kim CJ, Sim DS, Kim JH, Hong YJ, Jeong MH, Chang K, Ahn Y. Impact of Low Baseline Low-Density Lipoprotein Cholesterol on Long-Term Postdischarge Cardiovascular Outcomes in Patients With Acute Myocardial Infarction. J Am Heart Assoc. 2022 Sep 6;11(17):e025958. doi: 10.1161/JAHA.122.025958. Epub 2022 Aug 24.'}, {'pmid': '34737035', 'type': 'DERIVED', 'citation': 'Lee M, Lee K, Kim DW, Cho JS, Kim TS, Kwon J, Kim CJ, Park CS, Kim HY, Yoo KD, Jeon DS, Chang K, Kim MC, Jeong MH, Ahn Y, Park MW. Relationship of Serial High-Sensitivity C-Reactive Protein Changes to Long-term Clinical Outcomes in Stabilised Patients After Myocardial Infarction. Can J Cardiol. 2022 Jan;38(1):92-101. doi: 10.1016/j.cjca.2021.10.007. Epub 2021 Nov 2.'}]}, 'descriptionModule': {'briefSummary': 'This study is intended to provide contemporary data on the residual cardiovascular risk in all consecutive patients with acute myocardial infarction, especially in patients who survived stably within one-year after percutaneous coronary intervention.\n\nIn addition, this study will identify which baseline clinical, angiographic, or treatment factors are associated with residual cardiovascular risk and bleeding events', 'detailedDescription': "COREA-AMI registry was conducted previously (NCT02385682) and enrolled consecutive all patient with acute myocardial infarction who were treated with percutaneous coronary intervention from Jan 2004 to Dec 2009.\n\nCOREA-AMI II registry extend the enrollment period to Aug 2014 and the follow-up period to Jun 2016.\n\nAll consecutive acute myocardial infarction patients had been enrolled prospectively in prior registries of each university hospitals. Eight hospitals of the Catholic University of Korea already have web-based coronary intervention registry (NCT01239914). And Cheonnam University Hospital is one of leading hospitals to design and manage the web-based previous Korean nationwide myocardial infarction registry, the Korea Acute Myocardial Infarction Registry (KAMIR) (http://www.kamir.or.kr/).\n\nUsing these previous data, the current registry update new clinical and angiographic variables and assess long-term clinical follow-up data retrospectively. All data were collected on web-based system after eliminating personal information. (http://www.ecrf.kr/coreaami/)\n\nAll data are going to be sealed with code by Clinical Research Coordinating Center of the Catholic University of Korea and to be managed and analyzed by independent statistics perssonels.\n\nCardiovascular center with high-volume percutaneous coronary intervention of following hospitals were participated.\n\n* Seoul St. Mary's Hospital, Seoul, South Korea\n* Yeoido St. Mary's Hospital, Seoul, South Korea\n* Uijongbu St. Mary's Hospital, Gyeonggi-do, South Korea\n* St. Paul Hospital, Seoul, South Korea\n* Bucheon St. Mary's Hospital, Gyeonggi-do, South Korea\n* Incheon St. Mary's Hospital, Incheon, South Korea\n* St. Vincent Hospital, Gyeonggi-do, South Korea\n* Deajon St. Mary's Hospital, Daejeon, South Korea\n* Cheonnam University Hospital, Gwangju, South Korea"}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '20 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Acute myocardial infarction who were treated with percutaneous coronary intervention', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Acute myocardial infarction who were treated with percutaneous coronary intervention using stents\n\nExclusion Criteria:\n\n* Acute myocardial infarction who were treated with only balloon angioplasty\n* Acute myocardial infarction who were managed by conservative strategy'}, 'identificationModule': {'nctId': 'NCT02806102', 'briefTitle': 'CardiOvascular Risk and idEntificAtion of Potential High-risk Population in Acute Myocardial Infarction II (COREA-AMI II)', 'organization': {'class': 'OTHER', 'fullName': "Seoul St. Mary's Hospital"}, 'officialTitle': 'Cardiovascular Risk and Identification of Potential High-risk Population in Korean Patients With Acute Myocardial Infarction II (COREA-AMI II)', 'orgStudyIdInfo': {'id': 'XC15RSMI0089K'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'High-risk', 'description': 'Acute myocardial infarction treated with percutaneous coronary intervention and/or long-term use of dual-antiplatelet therapy and have at least one of the following risk factors:\n\n* Age ≥ 65 years\n* Diabetes mellitus requiring medication\n* Documented history of a second prior presumed spontaneous MI (\\>1 year ago)\n* Documented history of angiographic evidence of multivessel coronary artery disease\n* Chronic, non-end stage renal dysfunction', 'interventionNames': ['Procedure: Percutaneous coronary intervention', 'Drug: Dual-antiplatelet therapy']}, {'label': 'Low-risk', 'description': 'Acute myocardial infarction treated with percutaneous coronary intervention and/or long-term use of dual-antiplatelet therapy and have none of the pre-specified risk factors', 'interventionNames': ['Procedure: Percutaneous coronary intervention', 'Drug: Dual-antiplatelet therapy']}], 'interventions': [{'name': 'Percutaneous coronary intervention', 'type': 'PROCEDURE', 'otherNames': ['PCI'], 'description': 'Percutaneous coronary intervention', 'armGroupLabels': ['High-risk']}, {'name': 'Dual-antiplatelet therapy', 'type': 'DRUG', 'otherNames': ['DAPT'], 'description': 'Dual AntiPlatelet Therapy', 'armGroupLabels': ['High-risk']}, {'name': 'Percutaneous coronary intervention', 'type': 'PROCEDURE', 'otherNames': ['PCI'], 'description': 'Percutaneous coronary intervention', 'armGroupLabels': ['Low-risk']}, {'name': 'Dual-antiplatelet therapy', 'type': 'DRUG', 'otherNames': ['DAPT'], 'description': 'Dual AntiPlatelet Therapy', 'armGroupLabels': ['Low-risk']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Gwangju', 'status': 'RECRUITING', 'country': 'South Korea', 'contacts': [{'name': 'Youngkeun Ahn, MD, PhD', 'role': 'CONTACT', 'email': 'cecilyk@chonnam.ac.kr', 'phone': '82-62-220-6263'}], 'facility': 'Chonnam National University Hospital', 'geoPoint': {'lat': 35.15472, 'lon': 126.91556}}, {'city': 'Seoul', 'status': 'RECRUITING', 'country': 'South Korea', 'contacts': [{'name': 'Kiyuk Chang, MD, PhD', 'role': 'CONTACT', 'email': 'kiyuk@catholic.ac.kr', 'phone': '82-2-2258-1139'}, {'name': 'Kiyuk Chang, MD, PhD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': "Seoul St. Mary's Hospital, The Catholic University of Korea", 'geoPoint': {'lat': 37.566, 'lon': 126.9784}}], 'centralContacts': [{'name': 'Kiyuk Chang, MD, PhD', 'role': 'CONTACT', 'email': 'kiyuk@catholic.ac.kr', 'phone': '82-2-2258-1139'}, {'name': 'Youngkeun Ahn, MD, PhD', 'role': 'CONTACT', 'email': 'cecilyk@chonnam.ac.kr', 'phone': '82-62-220-6263'}], 'overallOfficials': [{'name': 'Kiyuk Chang, MD, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': "Seoul St. Mary's Hospital"}, {'name': 'Youngkeun Ahn, MD, PhD', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Chonnam National University Hospital'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': "Seoul St. Mary's Hospital", 'class': 'OTHER'}, 'collaborators': [{'name': 'The Catholic University of Korea', 'class': 'OTHER'}, {'name': 'Chonnam National University', 'class': 'OTHER'}, {'name': 'AstraZeneca', 'class': 'INDUSTRY'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Chief of the Division of Cardiology', 'investigatorFullName': 'Kiyuk Chang', 'investigatorAffiliation': "Seoul St. Mary's Hospital"}}}}