Korea Acute Myocardial Infarction Registry

Официальное название

A Multicentre Observational Study to Improve Long-term Prognosis in Korean Patients With Acute Myocardial Infarction (Korea Acute Myocardial Infarction Registry [KAMIR-7])

Обзор

This multicentre observational registry study, the Korea Acute Myocardial Infarction Registry (KAMIR-7), aims to improve long-term prognosis in Korean patients with acute myocardial infarction (AMI) by establishing and operating a nationwide patient registry system. Participating hospitals across Korea, treating AMI patients, will contribute prospective clinical and health-related data. The registry system is web-based and designed to support various clinical and epidemiologic research initiatives, provide standardized data, and facilitate collaborative studies, including participation in international studies such as GRACE. The primary objectives are: 1. To establish and maintain a sustainable nationwide AMI patient registry to enable continuous collection of high-quality clinical data. 2. To develop a Korean-specific AMI prognostic model by evaluating the applicability and discriminative power of existing foreign risk prediction models (e.g., GRACE score, TIMI score, PERSUIT model, ACTION score) using domestic patient data. 3. To identify clinical and management factors significantly affecting AMI outcomes and model mortality risk using accessible clinical and initial presentation data, including total ischemic time (symptom-to-hospital and door-to-balloon time). 4. To develop clinical and quality indicators to evaluate appropriateness of care and emergency management systems, incorporating patient transport, pre-hospital management, and hospital treatment timeliness. Secondary objectives include: * To ensure sustainable patient enrollment and prospective follow-up systems that can support clinical and public health research. * To create a resource for future research on new antiplatelet agents, stents, or interventional strategies. * To provide data for nested case-control studies within the cohort, facilitating research on clinical characteristics, treatment courses, and outcomes in AMI patients. * To identify new prognostic factors influencing patient outcomes and establish guidelines appropriate for Korean clinical practice. * To address limitations of prior KAMIR studies, including short follow-up duration and limited heart failure-related data, and incorporate evolving treatment strategies, devices, and medications. Through systematic data collection and networked collaboration, this study will enable comprehensive analyses of long-term outcomes in Korean AMI patients, contribute to evidence-based optimization of treatment strategies, support development of prognostic tools specific to the Korean population, and inform health policy and clinical guideline refinement. The registry will also foster research collaboration among hospitals, investigators, and international study networks to advance the understanding and management of AMI in Korea.

Подробное описание

This is a multicenter, prospective, observational registry study of patients diagnosed with acute myocardial infarction (AMI) at participating hospitals across Korea. Patients are identified and enrolled from hospitals treating AMI nationwide. All data are entered into a web-based electronic case report form (eCRF) system and centrally managed, with no personally identifiable information collected.

Each patient is assigned a unique study identification number, separate from any hospital-specific patient ID, to ensure confidentiality. Data entry is performed by trained study coordinators following standardized procedures. The coordinators undergo professional training, and continuous monitoring of data entry practices, registration progress, and ongoing study operations is conducted. A core-lab coordinator visits each participating site and facilitates staff interactions and exchange work to minimize inter-site bias and ensure standardized, high-quality data collection. All collected measures are defined according to standardized definitions to maintain consistency across sites.

Follow-up data will be collected at 6, 12, 24, and 36 months after the index procedure.

Data Privacy and Security Measures All personally identifiable information, such as names, resident registration numbers, hospital numbers, addresses, email addresses, and phone numbers, will not be collected. Collected information is managed using a unique study number for each patient. The eCRF system is secured with account-specific login credentials and passwords. Access is restricted to study personnel authorized by the principal investigator.

The study database is regularly monitored to maintain data quality, and measures are in place to standardize data collection and minimize bias. Patient confidentiality is protected throughout the study, and all procedures comply with applicable regulations for data protection.

Research data will be stored for three years after the study completion according to the Bioethics Act. After the retention period, personal information will be destroyed in accordance with Article 16 of the Personal Information Protection Act Enforcement Decree.

Первичные конечные точки

• Major adverse cardiac events (MACE) during follow-up [Срок оценки: 6, 12, 24, and 36 months after index procedure]

Критерии участия

Критерии включения

• Age ≥ 19 years
• Patients diagnosed with acute myocardial infarction (AMI) (either ST-segment elevation myocardial infarction \[STEMI\] or non-ST-segment elevation myocardial infarction \[NSTEMI\]), meeting both of the following:
• Elevated cardiac troponin above the 99th percentile upper reference limit
• Evidence of myocardial ischemia, as indicated by symptoms, electrocardiographic (ECG) changes, and/or imaging evidence

Критерии исключения

\- Patients who do not provide informed consent to participate in this study

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Модель наблюдения

Когортное

Центры проведения

South Korea · 2 центра

• Chonnam National University Hospital — Gwangju
• Samsung Medical Center — Seoul

Идентификаторы

NCT: NCT07409441 · SMC 2025-10-089-007

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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