ST-segment Elevation Myocardial Infarction (STEMI)NCT03768453
EARLY-MYO-CMR Registry
An observational study of ST-segment Elevation Myocardial Infarction (STEMI), run by RenJi Hospital at 1 site in China.
Trial summary
The purpose of this registry is to depict the myocardial tissue characteristics in STEMI patients by CMR and other cardiac imaging modalities and to assess the prognostic value of imaging-derived indices. Information will be collected prospectively in about 1000 STEMI patients in 10 sites. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- ST-segment Elevation Myocardial Infarction (STEMI)
- How many people
- 1,000 participants
- Where
- 1 siteChina
- Study dates
- 8 May 2012to 1 Dec 2020
- Phase
- Observational
- Are there results?
- None posted in the registry
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: STEMI patients undergo CMR examination are eligible for this registry.
Who may be able to join
- STEMI patients who have had CMR imaging performed and have provided written consent.
- Patents older than 18 years old with myocardial infarction diagnosed by:
- typical ischemic symptom,
- New ischaemic ECG changes;: ≥2 mm ST-segment elevation in 2 contiguous precordial leads or ≥1 mm ST-segment elevation in 2 contiguous extremity leads ;
- elevated cardiac troponin value with at least one value above 99th percentile upper reference limit(UPL);
- confirmed by coronary angiography (CAG) or imaging evidence of new loss of viable myocardium or new regional wall motion abnormality in a pattern consistent with an ischaemic aetiology.
- Patients who have had CMR imaging performed and have agreed to comply with the follow up requirements.
Who cannot join
- Patient who is unable to comply with the follow-up schedule.
- Patient who has any medical conditions that in the opinion of the investigators will not be appropriate to participate in the study.
- Patient has a life expectancy of less than 6 months due to any condition.
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Ren Ji Hospital Affliated to School of Medicine, Shanghai Jiao Tong University
Shanghai, Shanghai Municipality, 200127
Jun Pu, Professor, 86-21-68383477, pujun310@hotmail.com
About this study
Official title: EARLY-MYO-CMR (EARLY Assessment of MYOcardial Tissue Characteristics by CMR in STEMI) Registry
The purpose of this registry is to depict the myocardial tissue characteristics in STEMI patients by CMR and other cardiac imaging modalities and to assess the prognostic value of imaging-derived indices. Information will be collected prospectively in about 1000 STEMI patients in 10 sites. Subjects will be followed for up to 5 years.
Read the detailed description
This is a prospective, multi-center, non-randomized, observational registry study of STEMI patients that undergo CMR examination. Information of other cardiac imagings and clinical outcomes are also prospectively collected in the database. This project will establish a prospective registry of 1000 STEMI patients in 10 sites with follow-ups of up to 5 years.
The aim of the project will be as following:
- To investigate myocardial tissue features and functional changes in STEMI patients.
- To identify CMR-derived indices that are associated with adverse clinical outcomes.
- To compare CMR with other alternative cardiac imaging modalities (i.e., echocardiography or SPECT) on prognostic prediction in STEMI patients.
- To compare myocardial tissue characteristics and functional changes in STEMI and NSTEMI patients (data derived from EARLY-MYO-CMR II Registry).
- Medical subject headings
- ST Elevation Myocardial Infarction
What is being measured
The primary outcome is the main question the study is designed to answer.
Major adverse cardiac events
MACE
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Dec 2018
- Study start8 May 2012
- Primary completion8 Jul 2020 (estimated)
- Study completion1 Dec 2020 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (6)Papers the sponsor has linked to this study.
- Other trials for ST-segment Elevation Myocardial Infarction (STEMI)Studies of the same condition, open and under way.
- More trials run by RenJi 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
- Case only
- Time perspective
- Prospective
- Enrolment
- 1,000 participants (estimated)
Sponsor and investigators
- Lead sponsor
- RenJi Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Jun Pu, Principal investigator, Renji Hospital, School of Medicine, Shanghai Jiaotong University.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03768453
- Sponsor's protocol ID
- EARLY-MYO-CMR
- Status last verified
- Jun 2019
- First submitted
- 3 Dec 2018
- Last updated
- 23 Jun 2020
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Jiang YJ, Wei L, Hou XC, Zhao Q, Zhao CX, Dong JX, Ge H, Yang YN, Pu J. The FIBR-CMR score: a novel risk model integrating fibrinogen and cardiac magnetic resonance for major adverse events after STEMI. Radiol Med. 2026 Oct 22. doi: 10.1007/s11547-026-02285-y. Online ahead of print.
PubMed 42911529Chen Y, Jiang M, Xia C, Zhao H, Ke P, Chen S, Ge H, Li K, Wang X, Wang Y, Chai Y, Liu Q, Tao Z, Lyu Y, Wu Y, Shi A, Liu Y, Xin H, Zhong Y, Zhang W, Yan F, Quan W, Xu Y, Liu D, Sun Y, Li X, Tian Y, Wu L, Tu S, Ji H, Sheng B, Pu J. A novel deep learning system for STEMI prognostic prediction from multi-sequence cardiac magnetic resonance. Sci Bull (Beijing). 2025 Dec 30;70(24):4241-4252. doi: 10.1016/j.scib.2025.11.027. Epub 2025 Nov 17.
PubMed 41314962Dong JX, Wei L, Jin LX, He J, Zhao CX, Ding S, Kong LC, Yang F, An DA, Wu CW, Chen BH, Wang HW, Yang YN, Ge H, Pu J. MR Uniformity Ratio Estimates to Evaluate Ventricular Mechanical Dyssynchrony and Prognosis After ST-Segment Elevation Myocardial Infarction. J Magn Reson Imaging. 2024 May;59(5):1820-1831. doi: 10.1002/jmri.28998. Epub 2023 Oct 13.
PubMed 37830268Lai W, Chen-Xu Z, Jian-Xun D, Jie H, Ling-Cong K, Dong-Ao-Lei A, Bing-Hua C, Song D, Zheng L, Fan Y, Hu-Wen W, Jian-Rong X, Heng G, Jun P. Prognostic implications of left ventricular torsion measured by feature-tracking cardiac magnetic resonance in patients with ST-elevation myocardial infarction. Eur Heart J Cardiovasc Imaging. 2023 May 31;24(6):785-795. doi: 10.1093/ehjci/jeac177.
PubMed 36056877Zhao Y, Lu X, Wan F, Gao L, Lin N, He J, Wei L, Dong J, Qin Z, Zhong F, Qiao Z, Wang W, Ge H, Ding S, Yang Y, Xiu J, Shan P, Yan F, Zhao S, Ji Y, Pu J. Disruption of Circadian Rhythms by Shift Work Exacerbates Reperfusion Injury in Myocardial Infarction. J Am Coll Cardiol. 2022 May 31;79(21):2097-2115. doi: 10.1016/j.jacc.2022.03.370.
PubMed 35618347Lai W, Jie H, Jian-Xun D, Ling-Cong K, Jun-Tong Z, Bo-Zhong S, Dong-Ao-Lei A, Bing-Hua C, Song D, Zheng L, Fan Y, Yi-Ning Y, Fu-Hua Y, Jian-Cheng X, Hu-Wen W, Jian-Rong X, Heng G, Jun P. Impact of Concomitant Impairments of the Left and Right Ventricular Myocardial Strain on the Prognoses of Patients With ST-Elevation Myocardial Infarction. Front Cardiovasc Med. 2021 May 31;8:659364. doi: 10.3389/fcvm.2021.659364. eCollection 2021.
PubMed 34136542
Study at a glance
From the registry record, last updated by the sponsor on 23 Jun 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- EARLY-MYO-CMR (EARLY Assessment of MYOcardial Tissue Characteristics by CMR in STEMI) Registry
- ClinicalTrials.gov ID
- NCT03768453
- Acronym / sponsor ID
- EARLY-MYO-CMR
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 1,000 participants (estimated)
- Lead sponsor
- RenJi HospitalUniversity, hospital or other
- Study start
- 8 May 2012 (actual)
- Primary completion
- 8 Jul 2020 (estimated)
- Study completion
- 1 Dec 2020 (estimated)
- First posted
- 7 Dec 2018 (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.
The purpose of this registry is to depict the myocardial tissue characteristics in STEMI patients by CMR and other cardiac imaging modalities and to assess the prognostic value of imaging-derived indices. Information will be collected prospectively in about 1000 STEMI patients in 10 sites. Subjects will be followed for up to 5 years.
Detailed description
This is a prospective, multi-center, non-randomized, observational registry study of STEMI patients that undergo CMR examination. Information of other cardiac imagings and clinical outcomes are also prospectively collected in the database. This project will establish a prospective registry of 1000 STEMI patients in 10 sites with follow-ups of up to 5 years.
The aim of the project will be as following:
- To investigate myocardial tissue features and functional changes in STEMI patients.
- To identify CMR-derived indices that are associated with adverse clinical outcomes.
- To compare CMR with other alternative cardiac imaging modalities (i.e., echocardiography or SPECT) on prognostic prediction in STEMI patients.
- To compare myocardial tissue characteristics and functional changes in STEMI and NSTEMI patients (data derived from EARLY-MYO-CMR II Registry).
Study design
- Observational model
- Case only
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- STEMI patients undergo CMR examination are eligible for this registry.
Key inclusion criteria (7 listed)
- STEMI patients who have had CMR imaging performed and have provided written consent.
- Patents older than 18 years old with myocardial infarction diagnosed by:
- Patients who have had CMR imaging performed and have agreed to comply with the follow up requirements.
Key exclusion criteria (3 listed)
- Patient who is unable to comply with the follow-up schedule.
- Patient who has any medical conditions that in the opinion of the investigators will not be appropriate to participate in the study.
- Patient has a life expectancy of less than 6 months due to any condition.
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: 1 year
MACE
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Jun 2020.
- Derived from this study: PubMed 42911529Jiang YJ, Wei L, Hou XC, Zhao Q, Zhao CX, Dong JX, Ge H, Yang YN, Pu J. The FIBR-CMR score: a novel risk model integrating fibrinogen and cardiac magnetic resonance for major adverse events after STEMI. Radiol Med. 2026 Oct 22. doi: 10.1007/s11547-026-02285-y. Online ahead of print.
- Derived from this study: PubMed 41314962Chen Y, Jiang M, Xia C, Zhao H, Ke P, Chen S, Ge H, Li K, Wang X, Wang Y, Chai Y, Liu Q, Tao Z, Lyu Y, Wu Y, Shi A, Liu Y, Xin H, Zhong Y, Zhang W, Yan F, Quan W, Xu Y, Liu D, Sun Y, Li X, Tian Y, Wu L, Tu S, Ji H, Sheng B, Pu J. A novel deep learning system for STEMI prognostic prediction from multi-sequence cardiac magnetic resonance. Sci Bull (Beijing). 2025 Dec 30;70(24):4241-4252. doi: 10.1016/j.scib.2025.11.027. Epub 2025 Nov 17.
- Derived from this study: PubMed 37830268Dong JX, Wei L, Jin LX, He J, Zhao CX, Ding S, Kong LC, Yang F, An DA, Wu CW, Chen BH, Wang HW, Yang YN, Ge H, Pu J. MR Uniformity Ratio Estimates to Evaluate Ventricular Mechanical Dyssynchrony and Prognosis After ST-Segment Elevation Myocardial Infarction. J Magn Reson Imaging. 2024 May;59(5):1820-1831. doi: 10.1002/jmri.28998. Epub 2023 Oct 13.
- Derived from this study: PubMed 36056877Lai W, Chen-Xu Z, Jian-Xun D, Jie H, Ling-Cong K, Dong-Ao-Lei A, Bing-Hua C, Song D, Zheng L, Fan Y, Hu-Wen W, Jian-Rong X, Heng G, Jun P. Prognostic implications of left ventricular torsion measured by feature-tracking cardiac magnetic resonance in patients with ST-elevation myocardial infarction. Eur Heart J Cardiovasc Imaging. 2023 May 31;24(6):785-795. doi: 10.1093/ehjci/jeac177.
- Derived from this study: PubMed 35618347Zhao Y, Lu X, Wan F, Gao L, Lin N, He J, Wei L, Dong J, Qin Z, Zhong F, Qiao Z, Wang W, Ge H, Ding S, Yang Y, Xiu J, Shan P, Yan F, Zhao S, Ji Y, Pu J. Disruption of Circadian Rhythms by Shift Work Exacerbates Reperfusion Injury in Myocardial Infarction. J Am Coll Cardiol. 2022 May 31;79(21):2097-2115. doi: 10.1016/j.jacc.2022.03.370.
- Derived from this study: PubMed 34136542Lai W, Jie H, Jian-Xun D, Ling-Cong K, Jun-Tong Z, Bo-Zhong S, Dong-Ao-Lei A, Bing-Hua C, Song D, Zheng L, Fan Y, Yi-Ning Y, Fu-Hua Y, Jian-Cheng X, Hu-Wen W, Jian-Rong X, Heng G, Jun P. Impact of Concomitant Impairments of the Left and Right Ventricular Myocardial Strain on the Prognoses of Patients With ST-Elevation Myocardial Infarction. Front Cardiovasc Med. 2021 May 31;8:659364. doi: 10.3389/fcvm.2021.659364. eCollection 2021.
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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.
Jun Pu principal investigator
Renji Hospital, School of Medicine, Shanghai Jiaotong University.
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-segment Elevation Myocardial Infarction (STEMI), run by RenJi 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 7 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: status not confirmed, as of the sponsor's last update on 23 Jun 2020. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Jun Pu (08602168383164, pujun310@hotmail.com), 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: 1 year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03768453, which also lists 6 linked publications.
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 23 Jun 2020; AzTrials last refreshed its copy on 3 Nov 2026.