- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07277400
Development and Validation of a Cardiac Magnetic Resonance-Based Multimodal Deep Learning Model for Long-Term Outcome Prediction in ST-Segment Elevation Myocardial Infarction
Objective: This study aims to develop and test a novel artificial intelligence-based prediction model. This model will integrate cardiac magnetic resonance imaging and clinical data to predict the long-term risk of major adverse cardiovascular events in patients who have undergone emergency percutaneous coronary intervention for ST-segment elevation myocardial infarction.
Description: This study plans to enroll patients with STEMI who have received primary PCI. Approximately one week after the procedure, patients will undergo a cardiac magnetic resonance scan. Concurrently, we will collect patients' basic information, blood test results during treatment, and procedural records. Thereafter, patients will be followed up regularly (every six months) to record the occurrence of any major adverse cardiac events, such as cardiovascular death, recurrent myocardial infarction, hospitalization for heart failure, or unplanned repeat revascularization.All collected data, including clinical data and analyzed cardiac MR images, will be used to construct a multimodal deep learning model. The model will learn to identify features associated with future cardiac problems. The accuracy of the model will be tested and validated in different patient groups.
Potential Impact: If successful, this prediction tool could assist physicians in identifying high-risk patients earlier and more accurately, enabling closer monitoring and more timely interventions, ultimately improving the long-term prognosis for these patients.
Study Overview
Status
Conditions
Study Type
Enrollment (Estimated)
Contacts and Locations
Study Contact
- Name: Geng Qian, MD
- Phone Number: +86 13810914587
- Email: qiangeng9396@263.net
Study Locations
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Beijing Municipality
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Beijing, Beijing Municipality, China, 100853
- Chinese PLA General Hospital
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Sampling Method
Study Population
Description
Inclusion Criteria:
(1)diagnosis of STEMI , elevated cardiac biomarkers (troponin) above the 99th percentile upper reference limit together with at least one of the following: chest pain lasting >30 minutes; ST-segment elevation ≥0.1 mV in two or more contiguous limb leads or ≥0.2 mV in two or more contiguous precordial leads on a 12-lead ECG; (2) age >18 years, first episode of STEMI treated with primary PCI; (3)diagnostic and therapeutic management consistent with current clinical standards and guideline recommendations; (4) Killip class≤III at presentation; (5) provided informed consent for CMR imaging and clinical follow-up.
Exclusion Criteria:
(1) contraindications to CMR (e.g., cardiac pacemakers, severe claustrophobia, known allergy to gadolinium-based contrast agents, or impaired renal function defined as eGFR<30mL/min/1.73m²). (2) structural heart disease (e.g., significant valvular or congenital disease); (3) documented history of prior myocardial infarction, PCI, or coronary artery bypass grafting (CABG); (4) comorbidities severely compromising overall prognosis or the ability to undergo the study procedures, such as serious hematological disorders, active systemic infections, or active malignancy; (5) cognitive impairment or psychiatric conditions precluding adequate cooperation with the CMR examination or clinical follow-up; (6) Poor-quality CMR images or missing essential sequences precluding accurate quantitative analysis.
Study Plan
How is the study designed?
Design Details
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
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major adverse cardiac events
Time Frame: 2024-2026
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major adverse cardiac events, such as cardiovascular death, recurrent myocardial infarction, hospitalization for heart failure, or unplanned repeat revascularization.
|
2024-2026
|
Collaborators and Investigators
Sponsor
Collaborators
Study record dates
Study Major Dates
Study Start (Estimated)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- CMR-DL
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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