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The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details. Identifier: NCT03768453
Recruitment Status : Recruiting
First Posted : December 7, 2018
Last Update Posted : June 23, 2020
Information provided by (Responsible Party):
RenJi Hospital

Brief 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. Subjects will be followed for up to 5 years.

Condition or disease
ST-segment Elevation Myocardial Infarction (STEMI)

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:

  1. To investigate myocardial tissue features and functional changes in STEMI patients.
  2. To identify CMR-derived indices that are associated with adverse clinical outcomes.
  3. To compare CMR with other alternative cardiac imaging modalities (i.e., echocardiography or SPECT) on prognostic prediction in STEMI patients.
  4. To compare myocardial tissue characteristics and functional changes in STEMI and NSTEMI patients (data derived from EARLY-MYO-CMR II Registry).

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Study Type : Observational
Estimated Enrollment : 1000 participants
Observational Model: Case-Only
Time Perspective: Prospective
Official Title: EARLY-MYO-CMR (EARLY Assessment of MYOcardial Tissue Characteristics by CMR in STEMI) Registry
Actual Study Start Date : May 8, 2012
Estimated Primary Completion Date : July 8, 2020
Estimated Study Completion Date : December 1, 2020

Primary Outcome Measures :
  1. Major adverse cardiac events [ Time Frame: 1 year ]

Biospecimen Retention:   None Retained
Routine blood test includes CBC, Liver&Renal function, VBG, cardiac enzymes, glucose, serum lipid etc.

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
STEMI patients undergo CMR examination are eligible for this registry.

Inclusion Criteria:

STEMI patients who have had CMR imaging performed and have provided written consent.

  1. Patents older than 18 years old with myocardial infarction diagnosed by:

    1. typical ischemic symptom,
    2. 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 ;
    3. elevated cardiac troponin value with at least one value above 99th percentile upper reference limit(UPL);
    4. 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.
  2. Patients who have had CMR imaging performed and have agreed to comply with the follow up requirements.

Exclusion Criteria:

  1. Patient who is unable to comply with the follow-up schedule.
  2. Patient who has any medical conditions that in the opinion of the investigators will not be appropriate to participate in the study.
  3. Patient has a life expectancy of less than 6 months due to any condition.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT03768453

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Contact: Jun Pu 08602168383164
Contact: Heng Ge 08602168383164

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China, Shanghai
Ren Ji Hospital Affliated to School of Medicine, Shanghai Jiao Tong University Recruiting
Shanghai, Shanghai, China, 200127
Contact: Jun Pu, Professor    86-21-68383477   
Sponsors and Collaborators
RenJi Hospital
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Principal Investigator: Jun Pu Renji Hospital, School of Medicine, Shanghai Jiaotong University.
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Responsible Party: RenJi Hospital Identifier: NCT03768453    
Other Study ID Numbers: EARLY-MYO-CMR
First Posted: December 7, 2018    Key Record Dates
Last Update Posted: June 23, 2020
Last Verified: June 2019

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Myocardial Infarction
ST Elevation Myocardial Infarction
Pathologic Processes
Myocardial Ischemia
Heart Diseases
Cardiovascular Diseases
Vascular Diseases