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EARLY-MYO-CMR-II Registry

EARLY-MYO-CMR-II (EARLY Assessment of MYOcardial Tissue Characteristics by CMR in NSTEMI) Registry

Status
UNKNOWN
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT03995433
Enrollment
2000
Registered
2019-06-24
Start date
2012-05-08
Completion date
2019-12-09
Last updated
2019-06-24

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Non-ST-Segment Elevation Myocardial Infarction (NSTEMI)

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.

Detailed description

This is a prospective, multi-center, non-randomized, observational registry study of NSTEMI 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 2000 NSTEMI 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 pathological features and functional changes in NSTEMI 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 NSTEMI patients. 4. To compare myocardial tissue characteristics and functional changes in STEMI (data derived from EARLY-MYO-CMR) and NSTEMI patients. 5. To verify GRACE Score classification in NSTEMI from CMR imaging view.

Interventions

None listed

Sponsors

RenJi Hospital
Lead SponsorOTHER

Study design

Observational model
CASE_ONLY
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

Inclusion criteria

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): 1. Ischemic symptoms (chest pain or equivalent) at rest ≥ 10 minutes within 24 hours of randomization, 2. One of the two following criteria: 1. 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, 2. 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, 3. 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.

Design outcomes

Primary

MeasureTime frame
Major adverse cardiac events(MACE)1 year

Countries

China

Contacts

Primary ContactJun Pu
pujun310@hotmail.com08602168383164
Backup ContactHeng Ge
dr.geheng@foxmail.com08602168383164

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026