EARLY-MYO-CMR-II Registry

Non-ST-Segment Elevation Myocardial Infarction (NSTEMI) Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03995433
• Other study ID #: EARLY-MYO-CMR-II
• Status: Recruiting
• Start date: May 8, 2012
• Est. completion date: December 9, 2019

Study information

• Verified date: June 2019
• Source: RenJi Hospital
• Contact: Jun Pu
• Phone: 08602168383164
• Email: pujun310[@]hotmail.com
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 2000
• Est. completion date: December 9, 2019
• Est. primary completion date: July 8, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Infarction
• Myocardial Infarction
• Non-ST Elevated Myocardial Infarction
• Non-ST-Segment Elevation Myocardial Infarction (NSTEMI)

Locations

Country	Name	City	State
China	Ren Ji Hospital Affliated to School of Medicine, Shanghai Jiao Tong University	Shanghai	Shanghai

Sponsors (1)

Lead Sponsor	Collaborator
RenJi Hospital

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Major adverse cardiac events(MACE)		1 year