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出境医 / 临床实验 / EARLY-MYO-CMR-II Registry

EARLY-MYO-CMR-II Registry

Study Description
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.

Condition or disease
Non-ST-Segment Elevation Myocardial Infarction (NSTEMI)

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 Design
Layout table for study information
Study Type : Observational
Estimated Enrollment : 2000 participants
Observational Model: Case-Only
Time Perspective: Prospective
Official Title: EARLY-MYO-CMR-II (EARLY Assessment of MYOcardial Tissue Characteristics by CMR in NSTEMI) Registry
Actual Study Start Date : May 8, 2012
Estimated Primary Completion Date : July 8, 2019
Estimated Study Completion Date : December 9, 2019
Arms and Interventions
Outcome Measures
Primary Outcome Measures :
  1. Major adverse cardiac events(MACE) [ Time Frame: 1 year ]

Eligibility Criteria
Layout table for eligibility information
Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
NSTEMI patients undergo CMR examination are eligible for this registry.
Criteria

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.
Contacts and Locations

Contacts
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Contact: Jun Pu 08602168383164 pujun310@hotmail.com
Contact: Heng Ge 08602168383164 dr.geheng@foxmail.com

Locations
Layout table for location information
China, Shanghai
Ren Ji Hospital Affliated to School of Medicine, Shanghai Jiao Tong University Recruiting
Shanghai, Shanghai, China, 200127
Contact: Jun Pu    8602168383164    pujun310@hotmail.com   
Contact: Heng Ge    8602168383164    dr.geheng@foxmail.com   
Principal Investigator: Jun Pu         
Sponsors and Collaborators
RenJi Hospital
Investigators
Layout table for investigator information
Principal Investigator: Jun Pu Renji Hospital, School of Medicine, Shanghai Jiaotong University.
Tracking Information
First Submitted Date June 20, 2019
First Posted Date June 24, 2019
Last Update Posted Date June 24, 2019
Actual Study Start Date May 8, 2012
Estimated Primary Completion Date July 8, 2019   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: June 20, 2019) 		Major adverse cardiac events(MACE) [ Time Frame: 1 year ]
Original Primary Outcome Measures Same as current
Change History No Changes Posted
Current Secondary Outcome Measures Not Provided
Original Secondary Outcome Measures Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title EARLY-MYO-CMR-II Registry
Official Title EARLY-MYO-CMR-II (EARLY Assessment of MYOcardial Tissue Characteristics by CMR in NSTEMI) Registry
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.
Study Type Observational
Study Design Observational Model: Case-Only
Time Perspective: Prospective
Target Follow-Up Duration Not Provided
Biospecimen Not Provided
Sampling Method Non-Probability Sample
Study Population NSTEMI patients undergo CMR examination are eligible for this registry.
Condition Non-ST-Segment Elevation Myocardial Infarction (NSTEMI)
Intervention Not Provided
Study Groups/Cohorts Not Provided
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Unknown status
Estimated Enrollment
 (submitted: June 20, 2019) 		2000
Original Estimated Enrollment Same as current
Estimated Study Completion Date December 9, 2019
Estimated Primary Completion Date July 8, 2019   (Final data collection date for primary outcome measure)
Eligibility Criteria

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.
Sex/Gender
Sexes Eligible for Study: All
Ages 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers No
Contacts Contact information is only displayed when the study is recruiting subjects
Listed Location Countries China
Removed Location Countries  
 
Administrative Information
NCT Number NCT03995433
Other Study ID Numbers EARLY-MYO-CMR-II
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement
Plan to Share IPD: Undecided
Responsible Party RenJi Hospital
Study Sponsor RenJi Hospital
Collaborators Not Provided
Investigators
Principal Investigator: Jun Pu Renji Hospital, School of Medicine, Shanghai Jiaotong University.
PRS Account RenJi Hospital
Verification Date June 2019

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