Working...
ClinicalTrials.gov
ClinicalTrials.gov Menu

EARLY-MYO-CMR Registry

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT03768453
Recruitment Status : Recruiting
First Posted : December 7, 2018
Last Update Posted : June 24, 2019
Sponsor:
Information provided by (Responsible Party):
RenJi Hospital

Brief 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.

Condition or disease
ST-segment Elevation Myocardial Infarction (STEMI)

Detailed 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).

Layout table for study information
Study Type : Observational
Estimated Enrollment : 1000 participants
Observational Model: Case-Only
Time Perspective: Prospective
Official Title: EARLY-MYO-CMR (EARLY Assessment of MYOcardial Tissue Characteristics by CMR in STEMI) Registry
Actual Study Start Date : May 8, 2012
Estimated Primary Completion Date : July 8, 2019
Estimated Study Completion Date : December 1, 2019



Primary Outcome Measures :
  1. Major adverse cardiac events [ Time Frame: 1 year ]
    MACE


Biospecimen Retention:   None Retained
Routine blood test includes CBC, Liver&Renal function, VBG, cardiac enzymes, glucose, serum lipid etc.


Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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
STEMI patients undergo CMR examination are eligible for this registry.
Criteria

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. elevated ST segment at the J-point in two contiguous leads (ST elevation should be ≥2mm in men ≥40years; ≥2.5mm in men <40years, or ≥1.5mm in women regardless of age in leads V2 and V3; and ≥1mm in leads other than V2 and V3 );
    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 anterior myocardium.
  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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03768453


Contacts
Layout table for location contacts
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, Professor    86-21-68383477    pujun310@hotmail.com   
Sponsors and Collaborators
RenJi Hospital
Investigators
Layout table for investigator information
Principal Investigator: Jun Pu Renji Hospital, School of Medicine, Shanghai Jiaotong University.

Layout table for additonal information
Responsible Party: RenJi Hospital
ClinicalTrials.gov Identifier: NCT03768453     History of Changes
Other Study ID Numbers: EARLY-MYO-CMR
First Posted: December 7, 2018    Key Record Dates
Last Update Posted: June 24, 2019
Last Verified: June 2019

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:
Layout table for MeSH terms
Infarction
Myocardial Infarction
ST Elevation Myocardial Infarction
Ischemia
Pathologic Processes
Necrosis
Myocardial Ischemia
Heart Diseases
Cardiovascular Diseases
Vascular Diseases