EARLY-MYO-CMR Registry

NCT ID: NCT03768453

Last Updated: 2020-06-23

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Total Enrollment

1000 participants

Study Classification

OBSERVATIONAL

Study Start Date

2012-05-08

Study Completion Date

2020-12-01

Brief Summary

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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.

Detailed Description

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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).

Conditions

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ST-segment Elevation Myocardial Infarction (STEMI)

Study Design

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Observational Model Type

CASE_ONLY

Study Time Perspective

PROSPECTIVE

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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RenJi Hospital

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Jun Pu

Role: PRINCIPAL_INVESTIGATOR

Renji Hospital, School of Medicine, Shanghai Jiaotong University.

Locations

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Ren Ji Hospital Affliated to School of Medicine, Shanghai Jiao Tong University

Shanghai, Shanghai Municipality, China

Site Status RECRUITING

Countries

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China

Central Contacts

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Jun Pu

Role: CONTACT

08602168383164

Heng Ge

Role: CONTACT

08602168383164

Facility Contacts

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Jun Pu, Professor

Role: primary

86-21-68383477

References

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Dong JX, Wei L, Jin LX, He J, Zhao CX, Ding S, Kong LC, Yang F, An DA, Wu CW, Chen BH, Wang HW, Yang YN, Ge H, Pu J. MR Uniformity Ratio Estimates to Evaluate Ventricular Mechanical Dyssynchrony and Prognosis After ST-Segment Elevation Myocardial Infarction. J Magn Reson Imaging. 2024 May;59(5):1820-1831. doi: 10.1002/jmri.28998. Epub 2023 Oct 13.

Reference Type DERIVED
PMID: 37830268 (View on PubMed)

Lai W, Chen-Xu Z, Jian-Xun D, Jie H, Ling-Cong K, Dong-Ao-Lei A, Bing-Hua C, Song D, Zheng L, Fan Y, Hu-Wen W, Jian-Rong X, Heng G, Jun P. Prognostic implications of left ventricular torsion measured by feature-tracking cardiac magnetic resonance in patients with ST-elevation myocardial infarction. Eur Heart J Cardiovasc Imaging. 2023 May 31;24(6):785-795. doi: 10.1093/ehjci/jeac177.

Reference Type DERIVED
PMID: 36056877 (View on PubMed)

Zhao Y, Lu X, Wan F, Gao L, Lin N, He J, Wei L, Dong J, Qin Z, Zhong F, Qiao Z, Wang W, Ge H, Ding S, Yang Y, Xiu J, Shan P, Yan F, Zhao S, Ji Y, Pu J. Disruption of Circadian Rhythms by Shift Work Exacerbates Reperfusion Injury in Myocardial Infarction. J Am Coll Cardiol. 2022 May 31;79(21):2097-2115. doi: 10.1016/j.jacc.2022.03.370.

Reference Type DERIVED
PMID: 35618347 (View on PubMed)

Lai W, Jie H, Jian-Xun D, Ling-Cong K, Jun-Tong Z, Bo-Zhong S, Dong-Ao-Lei A, Bing-Hua C, Song D, Zheng L, Fan Y, Yi-Ning Y, Fu-Hua Y, Jian-Cheng X, Hu-Wen W, Jian-Rong X, Heng G, Jun P. Impact of Concomitant Impairments of the Left and Right Ventricular Myocardial Strain on the Prognoses of Patients With ST-Elevation Myocardial Infarction. Front Cardiovasc Med. 2021 May 31;8:659364. doi: 10.3389/fcvm.2021.659364. eCollection 2021.

Reference Type DERIVED
PMID: 34136542 (View on PubMed)

Other Identifiers

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EARLY-MYO-CMR

Identifier Type: -

Identifier Source: org_study_id

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