EARLY-MYO-CMR-II Registry
EARLY-MYO-CMR-II (EARLY Assessment of MYOcardial Tissue Characteristics by CMR in NSTEMI) Registry
1 other identifier
observational
2,000
1 country
1
Brief Summary
The purpose of this registry is to depict the myocardial tissue characteristics in NSTEMI 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 2000 NSTEMI patients in 10 sites. Subjects will be followed for up to 5 years.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started May 2012
Longer than P75 for all trials
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
May 8, 2012
CompletedFirst Submitted
Initial submission to the registry
June 20, 2019
CompletedFirst Posted
Study publicly available on registry
June 24, 2019
CompletedPrimary Completion
Last participant's last visit for primary outcome
July 8, 2019
CompletedStudy Completion
Last participant's last visit for all outcomes
December 9, 2019
CompletedJune 24, 2019
June 1, 2019
7.2 years
June 20, 2019
June 20, 2019
Conditions
Outcome Measures
Primary Outcomes (1)
Major adverse cardiac events(MACE)
1 year
Eligibility Criteria
NSTEMI patients undergo CMR examination are eligible for this registry.
You may qualify if:
- NSTEMI patients who have had CMR imaging performed and have provided written consent.
- Patient older than 18 years old with non-ST-segment elevation myocardial infarction (NSTEMI):
- Ischemic symptoms (chest pain or equivalent) at rest ≥ 10 minutes within 24 hours of randomization,
- One of the two following criteria:
- New ST-segment depression ≥ 0.1 mV (≥1 mm), or transient (\< 30 minutes) ST-segment elevation ≥ 0.1 mV (≥ 1 mm) in at least 2 contiguous leads on the electrocardiogram,
- Elevation of cardiac biomarkers within 24 hours of randomization, defined as elevated troponin T, troponin I, or CK-MB level above upper limit of normal,
- Patients who have had CMR imaging performed and have agreed to comply with the follow up requirements.
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- RenJi Hospitallead
Study Sites (1)
Ren Ji Hospital Affliated to School of Medicine, Shanghai Jiao Tong University
Shanghai, Shanghai Municipality, 200127, China
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Jun Pu
Renji Hospital, School of Medicine, Shanghai Jiaotong University.
Central Study Contacts
Study Design
- Study Type
- observational
- Observational Model
- CASE ONLY
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
June 20, 2019
First Posted
June 24, 2019
Study Start
May 8, 2012
Primary Completion
July 8, 2019
Study Completion
December 9, 2019
Last Updated
June 24, 2019
Record last verified: 2019-06