ST Elevation (STEMI) Myocardial InfarctionNCT07277400
Development and Validation of a Cardiac Magnetic Resonance-Based Multimodal Deep Learning Model for Long-Term Outcome Prediction in ST-Segment Elevation Myocardial Infarction
An observational study of ST Elevation (STEMI) Myocardial Infarction, run by Qian geng at 1 site in China.
Trial summary
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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- ST Elevation (STEMI) Myocardial Infarction
- How many people
- 800 participants
- Where
- 1 siteChina
- Study dates
- 31 Jan 2026to 30 Jun 2026
- 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: Adults over 18 with a first-time, primary PCI-treated STEMI, confirmed by biomarker and ECG criteria. Patients must be clinically stable (Killip class ≤ III) at presentation, have received guideline-adherent care, and provided informed consent for CMR and follow-up.
Who may be able to join
- (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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
About this study
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.
- Keywords
- cardiac magnetic resonance; ST-segment elevation myocardial infarction; deep learning; prediction model
- Medical subject headings
- ST Elevation Myocardial Infarction, Myocardial Infarction
What is being measured
The primary outcome is the main question the study is designed to answer.
major adverse cardiac events
major adverse cardiac events, such as cardiovascular death, recurrent myocardial infarction, hospitalization for heart failure, or unplanned repeat revascularization.
Measured: 2024-2026
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Dec 2025
- Study start31 Jan 2026 (estimated)
- Primary completion28 Feb 2026 (estimated)
- Study completion30 Jun 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for ST Elevation (STEMI) Myocardial InfarctionStudies of the same condition, open and under way.
- 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
- 800 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Qian geng
- Sponsor type
- University, hospital or other
- Collaborators
- Xi'an Jiaotong University, Beijing Anzhen Hospital, Second Affiliated Hospital of Nanchang University, First People's Hospital of Yulin, Guizhou Provincial People's Hospital, Jiangxi Provincial People's Hopital, First Affiliated Hospital of Xinjiang Medical University, People's Hospital of Xinjiang Uygur Autonomous Region, Beijing Chao Yang Hospital, Wuhan Asia Heart Hospital
- Responsible party
- Sponsor-investigator, Qian geng, Chinese PLA General Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07277400
- Sponsor's protocol ID
- CMR-DL
- Status last verified
- Oct 2025
- First submitted
- 30 Nov 2025
- Last updated
- 11 Dec 2025
- Results posted
- No
- Data monitoring committee
- Yes
- 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 11 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Development and Validation of a Cardiac Magnetic Resonance-Based Multimodal Deep Learning Model for Long-Term Outcome Prediction in ST-Segment Elevation Myocardial Infarction
- ClinicalTrials.gov ID
- NCT07277400
- Acronym / sponsor ID
- CMR-DL
- Keywords
- cardiac magnetic resonance; ST-segment elevation myocardial infarction; deep learning; prediction model
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 800 participants (estimated)
- Lead sponsor
- Qian gengUniversity, hospital or other
- Collaborators
- Xi'an Jiaotong University, Beijing Anzhen Hospital, Second Affiliated Hospital of Nanchang University, First People's Hospital of Yulin, Guizhou Provincial People's Hospital, Jiangxi Provincial People's Hopital, First Affiliated Hospital of Xinjiang Medical University, People's Hospital of Xinjiang Uygur Autonomous Region, Beijing Chao Yang Hospital, Wuhan Asia Heart Hospital
- Study start
- 31 Jan 2026 (estimated)
- Primary completion
- 28 Feb 2026 (estimated)
- Study completion
- 30 Jun 2026 (estimated)
- First posted
- 11 Dec 2025 (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.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Adults over 18 with a first-time, primary PCI-treated STEMI, confirmed by biomarker and ECG criteria. Patients must be clinically stable (Killip class ≤ III) at presentation, have received guideline-adherent care, and provided informed consent for CMR and follow-up.
Key inclusion criteria (1 listed)
- (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.
Key exclusion criteria (1 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
major adverse cardiac events
Time frame: 2024-2026
major adverse cardiac events, such as cardiovascular death, recurrent myocardial infarction, hospitalization for heart failure, or unplanned repeat revascularization.
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 11 Dec 2025.
- 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.
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 ST Elevation (STEMI) Myocardial Infarction, run by Qian geng 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 1 inclusion and 1 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: opening soon, as of the sponsor's last update on 11 Dec 2025. 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?
Contact Geng Qian, MD (+86 13810914587, qiangeng9396@263.net), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
major adverse cardiac events (time frame: 2024-2026). 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 11 Dec 2025.