Acute Myocardial Infarction Clinical Cohort

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.

Study Overview

• Status: Active, not recruiting
• Conditions: Acute Myocardial Infarction
• Intervention / Treatment: Diagnostic test: Deep multi-omics analysis; Diagnostic test: Advanced AI-Driven Cardiovascular Imaging

Detailed Description

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:

For all enrolled participants, the study will construct a holographic database encompassing structured electronic medical records (EMR), baseline demographics, laboratory tests, multi-modality imaging (ECG, Echocardiography, Coronary Angiography), and follow-up data. Peripheral blood samples (plasma, serum, and PBMCs) will be systematically collected from 1,200 patients, processed under strict Standard Operating Procedures (SOPs), and stored in a centralized, automated biobank.

Multi-omics and High-Risk Subgroup Analysis:

A targeted sub-cohort of 200 patients representing distinct clinical phenotypes (approximately 70 with vulnerable plaques, 60 with MINOCA, and 70 with borderline lesions) will undergo comprehensive multi-omics profiling. This includes:

1. Genomics: Whole Genome Sequencing (WGS) to identify genetic variants associated with lipid metabolism and AMI susceptibility.
2. Transcriptomics: RNA-seq to map gene expression profiles of immune cells.
3. Single-cell RNA-seq (scRNA-seq): Conducted on 80 high-risk patients to analyze the heterogeneity of peripheral immune cells and inflammatory responses.
4. Proteomics: Olink multiplex assay to quantify over 1,000 circulating proteins to identify early warning biomarkers for plaque rupture and myocardial injury.

Advanced Imaging Radiomics and AI Integration:

The study incorporates state-of-the-art cardiovascular imaging analysis, including Non-invasive CCTA radiomics, Optical Coherence Tomography (OCT), Intravascular Ultrasound (IVUS), Quantitative Flow Ratio (QFR), and novel Intracoronary Fluorescence Imaging. By utilizing artificial intelligence (AI) and machine learning algorithms, the study will extract multidimensional imaging and functional features to assess plaque vulnerability, vascular hemodynamics, and stent healing.

Study Objectives:

1. To build a standardized, multi-dimensional clinical and multi-omics database for Chinese AMI patients.
2. To identify and validate novel circulating biomarkers and therapeutic targets for AMI and its complications.
3. To develop and validate AI-driven, multi-modality diagnostic models for accurate risk stratification and prediction of Major Adverse Cardiovascular Events (MACE).
4. To provide robust clinical evidence and high-quality data to accelerate the translation of innovative cardiovascular medical devices and personalized therapies.

• Study Type: Observational
• Enrollment (Actual): 2000

Contacts and Locations

Study Locations

• China
  • Shanghai, China, 200000
    • Zhongshan Hospital, Fudan University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

A total of 2,000 adult patients diagnosed with Acute Myocardial Infarction (AMI) will be recruited from four major tertiary medical centers in Shanghai, China. The cohort will include adult patients of all genders, representing a typical Chinese AMI population. Within this overall cohort, a select subgroup of approximately 200 patients, exhibiting specific high-risk clinical phenotypes of AMI (including those with vulnerable plaques, Myocardial Infarction with Non-obstructive Coronary Arteries [MINOCA], and borderline coronary lesions), will undergo deeper clinical and molecular phenotyping. This is an observational cohort study.

Description

Inclusion Criteria:

• 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).

Exclusion Criteria:

• 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.

Study Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
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.	Diagnostic test: Deep multi-omics analysis; Comprehensive molecular profiling of peripheral blood samples using a multi-omics approach. This includes Whole Genome Sequencing (WGS) to identify genetic variants, bulk RNA sequencing (RNA-seq) for transcriptomic profiling, single-cell RNA sequencing (scRNA-seq) to analyze immune cell heterogeneity in high-risk patients, and Olink multiplex assays for high-throughput proteomics (>1,000 proteins). This analysis aims to identify novel circulating biomarkers and elucidate the molecular mechanisms of Acute Myocardial Infarction (AMI).; Diagnostic test: Advanced AI-Driven Cardiovascular Imaging; Detailed morphological and functional assessment of coronary arteries using advanced imaging modalities combined with artificial intelligence (AI) and radiomics. Assessments include Coronary Computed Tomography Angiography (CCTA) plaque radiomics, Optical Coherence Tomography (OCT), Intravascular Ultrasound (IVUS), Quantitative Flow Ratio (QFR) for hemodynamics, and novel Intracoronary Fluorescence Imaging. These tools are utilized to quantitatively evaluate plaque vulnerability, predict rupture risk, and develop AI-based prognostic models for AMI patients.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Major Adverse Cardiovascular Events (MACE)	Death, nonfatal myocardial infarction, revascularization, and stroke	At 1 month, 6 months and 12 months.

Collaborators and Investigators

• Sponsor: Shanghai Zhongshan Hospital
• Collaborators: RenJi Hospital; Shanghai 10th People's Hospital; Shanghai General Hospital, Shanghai Jiao Tong University School of Medicine

Study record dates

Study Major Dates

• Study Start (Actual): April 1, 2025
• Primary Completion (Estimated): December 31, 2026
• Study Completion (Estimated): December 31, 2028

Study Registration Dates

• First Submitted: April 3, 2026
• First Submitted That Met QC Criteria: April 3, 2026
• First Posted (Actual): April 13, 2026

Study Record Updates

• Last Update Posted (Actual): April 13, 2026
• Last Update Submitted That Met QC Criteria: April 3, 2026
• Last Verified: April 1, 2026

More Information

Terms related to this study

• Other Study ID Numbers: SHDC2025CCS001

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No