Acute Myocardial Infarction Clinical Cohort
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 2,000
- 试验地点
- 1
- 主要终点
- Major Adverse Cardiovascular Events (MACE)
研究概览
简要总结
This prospective, multicenter, observational cohort study aims to establish a comprehensive clinical database and high-quality biobank for patients with Acute Myocardial Infarction (AMI) in China. The study plans to enroll 2,000 AMI patients across four major medical centers to collect standardized clinical data, multi-modality imaging, and biological samples.
A key focus of this study is the deep phenotyping of high-risk subgroups, including patients with vulnerable plaques, Myocardial Infarction with Non-obstructive Coronary Arteries (MINOCA), and borderline coronary lesions. By integrating advanced multi-omics sequencing (Whole Genome Sequencing, RNA-seq, single-cell RNA sequencing, and Olink proteomics) with cutting-edge AI-driven imaging radiomics (CCTA, OCT, IVUS, and novel intracoronary fluorescence imaging), the study seeks to elucidate the molecular mechanisms of AMI. The ultimate goal is to discover novel biomarkers for early warning, develop precise risk prediction models for Major Adverse Cardiovascular Events (MACE), and facilitate the development of personalized diagnostic and therapeutic strategies for AMI patients.
详细描述
Background:
Despite advancements in cardiovascular medicine, Acute Myocardial Infarction (AMI) remains a leading cause of morbidity and mortality. Current risk stratification models and therapeutic strategies often lack population-specific precision, particularly for the Chinese demographic. Furthermore, specific high-risk subgroups-such as those with vulnerable plaques, MINOCA, and borderline coronary lesions-require deeper investigation to understand their unique pathophysiological mechanisms. This project initiates a Translational Research Cohort (TRC) to bridge the gap between basic multi-omics research, clinical imaging, and medical device innovation.
Study Design and Population:
This is a prospective, multicenter, observational study led by Zhongshan Hospital, Fudan University, in collaboration with three other major tertiary hospitals in Shanghai. The study will enroll 2,000 patients diagnosed with Coronary Heart Disease (CHD) and AMI.
Data Collection and Biobanking:
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 14 Years 至 —（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients diagnosed with Acute Myocardial Infarction (AMI), regardless of age or gender.
- •Patients willing and able to provide informed consent.
- •Patients identified to be part of specific high-risk AMI subgroups (for deep phenotyping), including:
- •AMI patients with high-risk vulnerable plaques (e.g., thin-cap fibroatheroma, large lipid core) identified by intracoronary imaging (OCT/NIRS).
- •AMI patients with non-obstructive coronary arteries (coronary stenosis <50% on angiography) and diagnosis confirmed by cardiac MRI (MINOCA).
- •AMI patients with borderline coronary lesions (50%-80% stenosis on angiography or CTA) requiring functional assessment (e.g., FFR/QFR/IVUS).
排除标准
- •Presence of severe non-cardiovascular comorbidities that would limit participation or confound study results.
- •Inability or unwillingness to comply with long-term follow-up requirements.
- •Patients who refuse to provide informed consent.
研究组 & 干预措施
Study cohort
A total of 2,000 patients diagnosed with Acute Myocardial Infarction (AMI) enrolled across four major medical centers in Shanghai. Baseline clinical data, multi-modality imaging, and long-term follow-up information will be collected for all participants. High-quality biological samples (whole blood, plasma, serum, PBMC) will be collected and banked for 1,200 of these patients.
Targeted High-Risk AMI Sub-Cohorts
Within the overall AMI cohort, a highly characterized sub-group of 200 patients will be selected based on specific clinical phenotypes for in-depth multi-omics (genomics, transcriptomics, proteomics, single-cell sequencing) and advanced AI-imaging analysis. This sub-group is divided into three distinct categories:
- AMI with High-Risk Vulnerable Plaques (approx. 70 patients): AMI patients characterized by highly vulnerable plaque features (e.g., thin-cap fibroatheroma, large lipid core) identified and evaluated via advanced intracoronary imaging (OCT/NIRS).
- MINOCA (approx. 60 patients): Patients presenting with AMI, but coronary angiography reveals <50% stenosis, further evaluated by cardiac MRI.
- AMI with Borderline Coronary Lesions (approx. 70 patients): AMI patients with 50% to 80% stenosis undergoing functional and imaging assessment (such as FFR, QFR, or IVUS) to guide individualized intervention strategies.
干预措施: Deep multi-omics analysis (Diagnostic Test)
Targeted High-Risk AMI Sub-Cohorts
Within the overall AMI cohort, a highly characterized sub-group of 200 patients will be selected based on specific clinical phenotypes for in-depth multi-omics (genomics, transcriptomics, proteomics, single-cell sequencing) and advanced AI-imaging analysis. This sub-group is divided into three distinct categories:
- AMI with High-Risk Vulnerable Plaques (approx. 70 patients): AMI patients characterized by highly vulnerable plaque features (e.g., thin-cap fibroatheroma, large lipid core) identified and evaluated via advanced intracoronary imaging (OCT/NIRS).
- MINOCA (approx. 60 patients): Patients presenting with AMI, but coronary angiography reveals <50% stenosis, further evaluated by cardiac MRI.
- AMI with Borderline Coronary Lesions (approx. 70 patients): AMI patients with 50% to 80% stenosis undergoing functional and imaging assessment (such as FFR, QFR, or IVUS) to guide individualized intervention strategies.
干预措施: Advanced AI-Driven Cardiovascular Imaging (Diagnostic Test)
结局指标
主要结局
Major Adverse Cardiovascular Events (MACE)
时间窗: At 1 month, 6 months and 12 months.
Death, nonfatal myocardial infarction, revascularization, and stroke
次要结局
未报告次要终点
研究者
Junbo Ge
Director of Department of Cardiology
Shanghai Zhongshan Hospital