EARLY-MYO-CMR-II Registry

June 20, 2019 updated by: RenJi Hospital

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

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.

Study Overview

Status

Unknown

Conditions

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.

Study Type

Observational

Enrollment (Anticipated)

2000

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • China
    • Shanghai
      • Shanghai, Shanghai, China, 200127
        • Recruiting
        • Ren Ji Hospital Affliated to School of Medicine, Shanghai Jiao Tong University
        • Contact:
        • Contact:
        • Principal Investigator:
          • Jun Pu

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

NSTEMI patients undergo CMR examination are eligible for this registry.

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Major adverse cardiac events(MACE)
Time Frame: 1 year
1 year

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

RenJi Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

May 8, 2012

Primary Completion (Anticipated)

July 8, 2019

Study Completion (Anticipated)

December 9, 2019

Study Registration Dates

First Submitted

June 20, 2019

First Submitted That Met QC Criteria

June 20, 2019

First Posted (Actual)

June 24, 2019

Study Record Updates

Last Update Posted (Actual)

June 24, 2019

Last Update Submitted That Met QC Criteria

June 20, 2019

Last Verified

June 1, 2019

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • EARLY-MYO-CMR-II

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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