NCT07537296 Coronary and Myocardial Evaluation by Cardiac CT for Acute Myocardial Infarction
| NCT ID | NCT07537296 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Nanjing First Hospital, Nanjing Medical University |
| Condition | Acute Myocardial Infarction (AMI) |
| Study Type | OBSERVATIONAL |
| Enrollment | 1,000 participants |
| Start Date | 2026-01-01 |
| Primary Completion | 2030-12-31 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
This is an observational study. You will not receive an experimental treatment; researchers will collect data based on your existing condition or standard treatment.
This trial targets 1,000 participants in total. It began in 2026-01-01 with a primary completion date of 2030-12-31.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief 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 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.
Eligibility Criteria
Inclusion Criteria: * 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 Exclusion Criteria: * 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
Frequently Asked Questions
Who can join the NCT07537296 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Acute Myocardial Infarction (AMI). Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT07537296 currently recruiting?
Yes, NCT07537296 is actively recruiting participants. Visit ClinicalTrials.gov or contact Nanjing First Hospital, Nanjing Medical University to inquire about joining.
Where is the NCT07537296 trial being conducted?
This trial is being conducted at Nanjing, China, Nanjing, China.
Who is sponsoring the NCT07537296 clinical trial?
NCT07537296 is sponsored by Nanjing First Hospital, Nanjing Medical University. The trial plans to enroll 1,000 participants.