EARLY-MYO-CMR Registry

ST-segment Elevation Myocardial Infarction (STEMI) Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03768453
• Other study ID #: EARLY-MYO-CMR
• Status: Recruiting
• Start date: May 8, 2012
• Est. completion date: December 1, 2020

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 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.

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).

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 1000
• Est. completion date: December 1, 2020
• Est. primary completion date: July 8, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Infarction
• Myocardial Infarction
• ST Elevation Myocardial Infarction
• ST-segment Elevation Myocardial Infarction (STEMI)

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