Acute Myocardial Infarction (AMI)COMET-AMINCT07537296
Coronary and Myocardial Evaluation by Cardiac CT for Acute Myocardial Infarction
An observational study of Acute Myocardial Infarction (AMI), run by Nanjing First Hospital, Nanjing Medical University at 2 sites in China.
Trial summary
Acute myocardial infarction (AMI) remains a major cause of mortality and morbidity worldwide. Although percutaneous coronary intervention (PCI) combined with guideline-directed medical therapy has substantially improved survival, many patients continue to experience adverse cardiovascular events after… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Acute Myocardial Infarction (AMI)
- What is being tested?
- Cardiac CT Follow-up and Echocardiographic Follow-up
- How many people
- 1,000 participants
- Where
- 2 sitesChina
- Study dates
- 1 Jan 2026to 31 Dec 2030
- How long will I take part?
- 5 Years
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: The study population was recruited from three large tertiary hospitals and included patients with acute myocardial infarction who underwent PCI.
Who may be able to join
- Age ≥18 years
- AMI within the previous 4 weeks, including STEMI or NSTEMI
- PCI performed for ACS culprit lesion according to current guidelines
- Hemodynamically stable
- Willingness to undergo multimodal cardiac CT within 7 days after PCI
- Willingness to participate in telephone follow-up
Who cannot join
- Contraindications to cardiac CT (eGFR <30 mL/min/1.73 m² or iodine contrast allergy)
- Previous coronary artery bypass graft surgery (CABG)
- History of heart failure or previous myocardial infarction
- Severe arrhythmia or structural heart disease
- Poor image quality or missing CT data
- Expected survival <6 months
Trial locations and contacts
2 sites in 1 country. Contact the study team or a site near you to ask about taking part.
China2 sites, 2 recruiting
- Recruiting
Nanjing First Hospital, Nanjing Medical University, 68 Changle road, Qinhuai District
Nanjing, Jiangsu, 210006
Qian Chen, +86-13851773831, yxchenqian@126.com
- Recruiting
Nanjing First Hospital, Nanjing Medical University, 68 Changle road, Qinhuai District
Nanjing, Jiangsu, 210006
Nailiang Tian, +86-13584056788, tiannailiang@163.com
About this study
Official title: Multimodal Cardiac CT-Derived High-Risk Coronary and Myocardial Features for Predicting Adverse Outcomes After PCI in Patients With Acute Myocardial Infarction: A Multicenter Prospective Cohort Study
Acute myocardial infarction (AMI) remains a major cause of mortality and morbidity worldwide. Although percutaneous coronary intervention (PCI) combined with guideline-directed medical therapy has substantially improved survival, many patients continue to experience adverse cardiovascular events after revascularization, including recurrent ischemic events, heart failure, and malignant arrhythmias. Therefore, accurate risk stratification after PCI is essential for optimizing clinical management and improving long-term outcomes. However, currently available risk prediction tools are limited by suboptimal predictive performance or restricted clinical accessibility.
Cardiac imaging plays a central role in post-AMI evaluation. Echocardiography is routinely recommended after PCI to assess cardiac structure and function and to exclude early mechanical complications. Nevertheless, its ability to predict subsequent ventricular remodeling and long-term clinical outcomes is limited. Cardiac magnetic resonance imaging (CMR) is considered the reference standard for myocardial tissue characterization and provides important prognostic markers such as infarct size, microvascular obstruction, and intramyocardial hemorrhage. However, the routine use of CMR in patients with AMI is constrained by limited availability, high cost, and relatively long examination time. In addition, CMR does not directly evaluate coronary artery anatomy or plaque characteristics, which are important determinants of recurrent ischemic events.
Read more
Recent advances in cardiac computed tomography (CT) have enabled comprehensive assessment of coronary artery disease. Beyond evaluating coronary stenosis, coronary CT angiography can identify high-risk plaque features associated with plaque vulnerability. Furthermore, emerging CT-based techniques allow simultaneous assessment of coronary physiology, perivascular inflammation, myocardial structure and function, and myocardial tissue characteristics. CT-derived fractional flow reserve (CT-FFR) enables noninvasive functional assessment of coronary lesions, while the fat attenuation index (FAI) reflects pericoronary inflammatory activity. In addition, delayed iodine enhancement and dual-energy CT techniques allow evaluation of myocardial injury and fibrosis, and CT-derived extracellular volume fraction (ECV) provides quantitative assessment of myocardial fibrosis. These advances suggest that multimodal cardiac CT may provide an integrated imaging approach for comprehensive risk assessment after AMI.
The COMET-AMI study (Coronary and Myocardial Evaluation by Multimodal Cardiac CT in Acute Myocardial Infarction) is a prospective, multicenter cohort study designed to evaluate the prognostic value of multimodal cardiac CT in patients with AMI after PCI. A total of 1,000 patients with AMI undergoing successful PCI will be prospectively enrolled. All participants will undergo multimodal cardiac CT within 7 days after PCI to assess coronary plaque characteristics, coronary physiology, pericoronary adipose tissue inflammation, cardiac structure and function, and myocardial tissue features. A subset of participants will also undergo cardiac magnetic resonance imaging for validation of CT-derived myocardial tissue parameters.
Comprehensive clinical information, including demographic characteristics, cardiovascular risk factors, medication history, laboratory biomarkers, and procedural data, will be collected. Quantitative and qualitative analyses of coronary plaques will be performed using dedicated software to assess plaque burden, plaque composition, remodeling characteristics, and high-risk plaque features. Additional CT-derived parameters such as CT-FFR, myocardial strain, pericoronary fat attenuation index, and extracellular volume fraction will also be analyzed.
Participants will be followed longitudinally through outpatient visits, telephone interviews, and electronic medical record review for up to five years after PCI. The primary outcomes include composite thrombotic events (cardiac death, recurrent myocardial infarction, and urgent or clinically driven revascularization). Secondary outcomes include heart failure and major arrhythmic events such as new-onset heart failure, sustained ventricular arrhythmia, implantable cardioverter-defibrillator implantation, sudden cardiac death, or resuscitated cardiac arrest. All clinical events will be independently adjudicated by a blinded clinical events committee.
Using multimodal cardiac CT-derived imaging biomarkers in combination with clinical and laboratory data, machine learning-based predictive models will be developed to identify key determinants of adverse outcomes after PCI in patients with AMI. The results of this study may provide a novel imaging-based risk stratification strategy and facilitate personalized management for patients with AMI after PCI.
- Conditions
- Acute Myocardial Infarction (AMI)
- Being tested
- Cardiac CT Follow-up and Echocardiographic Follow-up
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Cardiac CT Follow-up and Echocardiographic Follow-upDiagnostic test
All patients with AMI routinely undergo follow-up cardiac CT and echocardiography after PCI. Participants who remain free of thrombotic events, heart failure, or severe arrhythmias will be recommended to undergo repeat cardiac CT within 1 year after the baseline CT examination. Participants will undergo echocardiographic examinations at 6 months, 12 months, 2 years, 3 years, 4 years, and 5 years.
| Study group | Role | What they receive |
|---|---|---|
| the MACE group | patients who experienced study endpoint events during follow-up Receives: Diagnostic Test: Cardiac CT Follow-up and Echocardiographic Follow-up | |
| the non-MACE group | patients who did not experience study endpoint events during follow-up Receives: Diagnostic Test: Cardiac CT Follow-up and Echocardiographic Follow-up |
What is being measured
The primary outcome is the main question the study is designed to answer.
Thrombotic events
- cardiac death
- recurrent myocardial infarction
- urgent or clinically driven revascularization
Measured: Up to five years
Secondary outcomes (1)
Heart failure and arrhythmic events
- new-onset heart failure
- sustained ventricular arrhythmia
- ICD implantation
- sudden cardiac death
- resuscitated cardiac arrest
Measured: Up to five years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Apr 2026
- Study start1 Jan 2026
- Primary completion31 Dec 2030 (estimated)
- Study completion31 Dec 2030 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Acute Myocardial Infarction (AMI)Studies of the same condition, open and under way.
- More trials run by Nanjing First Hospital, Nanjing Medical UniversityThe 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
- 1,000 participants (estimated)
- Target duration
- 5 Years
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07537296
- Sponsor's protocol ID
- KY20260205-06
- Acronym
- COMET-AMI
- Status last verified
- Jan 2026
- First submitted
- 6 Apr 2026
- Last updated
- 17 Apr 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Multimodal Cardiac CT-Derived High-Risk Coronary and Myocardial Features for Predicting Adverse Outcomes After PCI in Patients With Acute Myocardial Infarction: A Multicenter Prospective Cohort Study
- ClinicalTrials.gov ID
- NCT07537296
- Acronym / sponsor ID
- COMET-AMI / KY20260205-06
- Conditions
- Acute Myocardial Infarction (AMI)
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 1,000 participants (estimated)
- Lead sponsor
- Nanjing First Hospital, Nanjing Medical UniversityUniversity, hospital or other
- Study start
- 1 Jan 2026 (actual)
- Primary completion
- 31 Dec 2030 (estimated)
- Study completion
- 31 Dec 2030 (estimated)
- First posted
- 17 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.
Acute myocardial infarction (AMI) remains a major cause of mortality and morbidity worldwide. Although percutaneous coronary intervention (PCI) combined with guideline-directed medical therapy has substantially improved survival, many patients continue to experience adverse cardiovascular events after revascularization, including recurrent ischemic events, heart failure, and malignant arrhythmias. Therefore, accurate risk stratification after PCI is essential for optimizing clinical management and improving long-term outcomes. However, currently available risk prediction tools are limited by suboptimal predictive performance or restricted clinical accessibility.
Cardiac imaging plays a central role in post-AMI evaluation. Echocardiography is routinely recommended after PCI to assess cardiac structure and function and to exclude early mechanical complications. Nevertheless, its ability to predict subsequent ventricular remodeling and long-term clinical outcomes is limited. Cardiac magnetic resonance imaging (CMR) is considered the reference standard for myocardial tissue characterization and provides important prognostic markers such as infarct size, microvascular obstruction, and intramyocardial hemorrhage. However, the routine use of CMR in patients with AMI is constrained by limited availability, high cost, and relatively long examination time. In addition, CMR does not directly evaluate coronary artery anatomy or plaque characteristics, which are important determinants of recurrent ischemic events.
Recent advances in cardiac computed tomography (CT) have enabled comprehensive assessment of coronary artery disease. Beyond evaluating coronary stenosis, coronary CT angiography can identify high-risk plaque features associated with plaque vulnerability. Furthermore, emerging CT-based techniques allow simultaneous assessment of coronary physiology, perivascular inflammation, myocardial structure and function, and myocardial tissue characteristics. CT-derived fractional flow reserve (CT-FFR) enables noninvasive functional assessment of coronary lesions, while the fat attenuation index (FAI) reflects pericoronary inflammatory activity. In addition, delayed iodine enhancement and dual-energy CT techniques allow evaluation of myocardial injury and fibrosis, and CT-derived extracellular volume fraction (ECV) provides quantitative assessment of myocardial fibrosis. These advances suggest that multimodal cardiac CT may provide an integrated imaging approach for comprehensive risk assessment after AMI.
The COMET-AMI study (Coronary and Myocardial Evaluation by Multimodal Cardiac CT in Acute Myocardial Infarction) is a prospective, multicenter cohort study designed to evaluate the prognostic value of multimodal cardiac CT in patients with AMI after PCI. A total of 1,000 patients with AMI undergoing successful PCI will be prospectively enrolled. All participants will undergo multimodal cardiac CT within 7 days after PCI to assess coronary plaque characteristics, coronary physiology, pericoronary adipose tissue inflammation, cardiac structure and function, and myocardial tissue features. A subset of participants will also undergo cardiac magnetic resonance imaging for validation of CT-derived myocardial tissue parameters.
Comprehensive clinical information, including demographic characteristics, cardiovascular risk factors, medication history, laboratory biomarkers, and procedural data, will be collected. Quantitative and qualitative analyses of coronary plaques will be performed using dedicated software to assess plaque burden, plaque composition, remodeling characteristics, and high-risk plaque features. Additional CT-derived parameters such as CT-FFR, myocardial strain, pericoronary fat attenuation index, and extracellular volume fraction will also be analyzed.
Participants will be followed longitudinally through outpatient visits, telephone interviews, and electronic medical record review for up to five years after PCI. The primary outcomes include composite thrombotic events (cardiac death, recurrent myocardial infarction, and urgent or clinically driven revascularization). Secondary outcomes include heart failure and major arrhythmic events such as new-onset heart failure, sustained ventricular arrhythmia, implantable cardioverter-defibrillator implantation, sudden cardiac death, or resuscitated cardiac arrest. All clinical events will be independently adjudicated by a blinded clinical events committee.
Using multimodal cardiac CT-derived imaging biomarkers in combination with clinical and laboratory data, machine learning-based predictive models will be developed to identify key determinants of adverse outcomes after PCI in patients with AMI. The results of this study may provide a novel imaging-based risk stratification strategy and facilitate personalized management for patients with AMI after PCI.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 5 Years
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| the MACE group | – | Diagnostic Test: Cardiac CT Follow-up and Echocardiographic Follow-uppatients who experienced study endpoint events during follow-up |
| the non-MACE group | – | Diagnostic Test: Cardiac CT Follow-up and Echocardiographic Follow-uppatients who did not experience study endpoint events during follow-up |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- The study population was recruited from three large tertiary hospitals and included patients with acute myocardial infarction who underwent PCI.
Key inclusion criteria (6 listed)
- Age ≥18 years
- AMI within the previous 4 weeks, including STEMI or NSTEMI
- PCI performed for ACS culprit lesion according to current guidelines
- Hemodynamically stable
- Willingness to undergo multimodal cardiac CT within 7 days after PCI
Key exclusion criteria (6 listed)
- Contraindications to cardiac CT (eGFR <30 mL/min/1.73 m² or iodine contrast allergy)
- Previous coronary artery bypass graft surgery (CABG)
- History of heart failure or previous myocardial infarction
- Severe arrhythmia or structural heart disease
- Poor image quality or missing CT data
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 |
|---|---|---|
| Cardiac CT Follow-up and Echocardiographic Follow-upAll patients with AMI routinely undergo follow-up cardiac CT and echocardiography after PCI. Participants who remain free of thrombotic events, heart failure, or severe arrhythmias will be recommended to undergo repeat cardiac CT within 1 year after the baseline CT examination. Participants will undergo echocardiographic examinations at 6 months, 12 months, 2 years, 3 years, 4 years, and 5 years. | Diagnostic test | the MACE group, the non-MACE group |
Primary outcome
Thrombotic events
Time frame: Up to five years
1. cardiac death 2. recurrent myocardial infarction 3. urgent or clinically driven revascularization
1 secondary outcome
Heart failure and arrhythmic events
Time frame: Up to five years
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 17 Apr 2026.
- Individual participant dataSharing planned: No
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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.
Nanjing First Hospital, Nanjing Medical University, 68 Changle road, Qinhuai District
Nanjing, China
Nanjing First Hospital, Nanjing Medical University, 68 Changle road, Qinhuai District
Nanjing, China
2 sites 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 (AMI), run by Nanjing First Hospital, Nanjing Medical University at 2 sites 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 6 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: looking for participants now, as of the sponsor's last update on 17 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 2 sites 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?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Thrombotic events (time frame: Up to five years). 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 17 Apr 2026.