Acute Myocardial InfarctionNCT07522164
Acute Myocardial Infarction Clinical Cohort
An observational study of Acute Myocardial Infarction, run by Shanghai Zhongshan Hospital at 1 site in China.
Trial 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. Read more about this study
- Who is it for?
- Ages 14 years and older
- Conditions the study is for
- Acute Myocardial Infarction
- What is being tested?
- Deep multi-omics analysis and Advanced AI-Driven Cardiovascular Imaging
- How many people
- 2,000 participants
- Where
- 1 siteChina
- Study dates
- 1 Apr 2025to 31 Dec 2028
- How long will I take part?
- 1 Year
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 14 years and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
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.
Who may be able to join
- 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).
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
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.
Read the 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:
- Genomics: Whole Genome Sequencing (WGS) to identify genetic variants associated with lipid metabolism and AMI susceptibility.
- Transcriptomics: RNA-seq to map gene expression profiles of immune cells.
- Single-cell RNA-seq (scRNA-seq): Conducted on 80 high-risk patients to analyze the heterogeneity of peripheral immune cells and inflammatory responses.
- 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:
- To build a standardized, multi-dimensional clinical and multi-omics database for Chinese AMI patients.
- To identify and validate novel circulating biomarkers and therapeutic targets for AMI and its complications.
- To develop and validate AI-driven, multi-modality diagnostic models for accurate risk stratification and prediction of Major Adverse Cardiovascular Events (MACE).
- To provide robust clinical evidence and high-quality data to accelerate the translation of innovative cardiovascular medical devices and personalized therapies.
- Conditions
- Acute Myocardial Infarction
- Being tested
- Deep multi-omics analysis, Advanced AI-Driven Cardiovascular Imaging
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Deep multi-omics analysisDiagnostic 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).
Advanced AI-Driven Cardiovascular ImagingDiagnostic 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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Diagnostic Test: Deep multi-omics analysis; Diagnostic Test: Advanced AI-Driven Cardiovascular Imaging |
What is being measured
The primary outcome is the main question the study is designed to answer.
Major Adverse Cardiovascular Events (MACE)
Death, nonfatal myocardial infarction, revascularization, and stroke
Measured: At 1 month, 6 months and 12 months.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Apr 2026
- Study start1 Apr 2025
- Primary completion31 Dec 2026 (estimated)
- Study completion31 Dec 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Acute Myocardial InfarctionStudies of the same condition, open and under way.
- More trials run by Shanghai Zhongshan HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 2,000 participants (actual)
- Target duration
- 1 Year
Sponsor and investigators
- Lead sponsor
- Shanghai Zhongshan Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Shanghai 10th People's Hospital, Shanghai General Hospital, Shanghai Jiao Tong University School of Medicine, RenJi Hospital
- Responsible party
- Principal investigator, Junbo Ge, Shanghai Zhongshan Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07522164
- Sponsor's protocol ID
- SHDC2025CCS001
- Status last verified
- Apr 2026
- First submitted
- 3 Apr 2026
- Last updated
- 13 Apr 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Acute Myocardial Infarction Clinical Cohort
- ClinicalTrials.gov ID
- NCT07522164
- Acronym / sponsor ID
- SHDC2025CCS001
- Conditions
- Acute Myocardial Infarction
- Study type
- Observational
- Recruitment status
- Active, not recruiting
- Enrolment
- 2,000 participants (actual)
- Lead sponsor
- Shanghai Zhongshan HospitalUniversity, hospital or other
- Collaborators
- Shanghai 10th People's Hospital, Shanghai General Hospital, Shanghai Jiao Tong University School of Medicine, RenJi Hospital
- Study start
- 1 Apr 2025 (actual)
- Primary completion
- 31 Dec 2026 (estimated)
- Study completion
- 31 Dec 2028 (estimated)
- First posted
- 13 Apr 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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:
- Genomics: Whole Genome Sequencing (WGS) to identify genetic variants associated with lipid metabolism and AMI susceptibility.
- Transcriptomics: RNA-seq to map gene expression profiles of immune cells.
- Single-cell RNA-seq (scRNA-seq): Conducted on 80 high-risk patients to analyze the heterogeneity of peripheral immune cells and inflammatory responses.
- 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:
- To build a standardized, multi-dimensional clinical and multi-omics database for Chinese AMI patients.
- To identify and validate novel circulating biomarkers and therapeutic targets for AMI and its complications.
- To develop and validate AI-driven, multi-modality diagnostic models for accurate risk stratification and prediction of Major Adverse Cardiovascular Events (MACE).
- To provide robust clinical evidence and high-quality data to accelerate the translation of innovative cardiovascular medical devices and personalized therapies.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 1 Year
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 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 | – | Diagnostic Test: Deep multi-omics analysis, Diagnostic Test: Advanced AI-Driven Cardiovascular ImagingWithin 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. |
Who may qualify
- Ages
- 14 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- 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.
Key inclusion criteria (6 listed)
- 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).
Key exclusion criteria (3 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Deep multi-omics analysisComprehensive 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 | Targeted High-Risk AMI Sub-Cohorts |
| Advanced AI-Driven Cardiovascular ImagingDetailed 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. | Diagnostic test | Targeted High-Risk AMI Sub-Cohorts |
Primary outcome
Major Adverse Cardiovascular Events (MACE)
Time frame: At 1 month, 6 months and 12 months.
Death, nonfatal myocardial infarction, revascularization, and stroke
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Apr 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Acute Myocardial Infarction, run by Shanghai Zhongshan Hospital at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 13 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Major Adverse Cardiovascular Events (MACE) (time frame: At 1 month, 6 months and 12 months.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Apr 2026.