Acute Myocardial Infarction Clinical Cohort

NCT07522164 | Active Not Recruiting DMC

• 1 other identifier: SHDC2025CCS001
• Study Type: observational
• Target: 2,000
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Acute Myocardial Infarction

Outcome Measures

Primary Outcomes (1)

• Major Adverse Cardiovascular Events (MACE)

  Death, nonfatal myocardial infarction, revascularization, and stroke

  At 1 month, 6 months and 12 months.

Study Arms (2)

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: 1. 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). 2. MINOCA (approx. 60 patients): Patients presenting with AMI, but coronary angiography reveals \<50% stenosis, further evaluated by cardiac MRI. 3. 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; Diagnostic Test: Advanced AI-Driven Cardiovascular Imaging

Interventions

Deep multi-omics analysis DIAGNOSTIC_TEST

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).

Targeted High-Risk AMI Sub-Cohorts

Advanced AI-Driven Cardiovascular Imaging DIAGNOSTIC_TEST

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.

Targeted High-Risk AMI Sub-Cohorts

Eligibility Criteria

• Age: 14 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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).

You may not qualify if:

• 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.

Sponsors & Collaborators

• Shanghai General Hospital, Shanghai Jiao Tong University School of Medicine: collaborator
• Shanghai Zhongshan Hospital: lead
• Shanghai 10th People's Hospital: collaborator
• RenJi Hospital: collaborator

Study Sites (1)

Zhongshan Hospital, Fudan University

Shanghai, 200000, China

Location

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 1 Year
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Director of Department of Cardiology

Study Record Dates

• First Submitted: April 3, 2026
• First Posted: April 13, 2026
• Study Start: April 1, 2025
• Primary Completion (Estimated): December 31, 2026
• Study Completion (Estimated): December 31, 2028
• Last Updated: April 13, 2026

Record last verified: 2026-04

Locations

CN (1)