Non-ST-Segment Elevation Myocardial Infarction (NSTEMI)NCT03995433
EARLY-MYO-CMR-II Registry
An observational study of Non-ST-Segment Elevation Myocardial Infarction (NSTEMI), run by RenJi Hospital at 1 site in China.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Non-ST-Segment Elevation Myocardial Infarction (NSTEMI)
- How many people
- 2,000 participants
- Where
- 1 siteChina
- Study dates
- 8 May 2012to 9 Dec 2019
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: NSTEMI patients undergo CMR examination are eligible for this registry.
Who may be able to join
- 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):
- Ischemic symptoms (chest pain or equivalent) at rest ≥ 10 minutes within 24 hours of randomization,
- One of the two following criteria:
- 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,
- 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,
- Patients who have had CMR imaging performed and have agreed to comply with the follow up requirements.
Who cannot join
- Patient who is unable to comply with the follow-up schedule.
- Patient who has any medical conditions that in the opinion of the investigators will not be appropriate to participate in the study.
- Patient has a life expectancy of less than 6 months due to any condition.
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Ren Ji Hospital Affliated to School of Medicine, Shanghai Jiao Tong University
Shanghai, Shanghai Municipality, 200127
Jun Pu, 8602168383164, pujun310@hotmail.com
Heng Ge, 8602168383164, dr.geheng@foxmail.com
About this study
Official title: 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.
Read the 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:
- To investigate myocardial pathological features and functional changes in NSTEMI patients.
- To identify CMR-derived indices that are associated with adverse clinical outcomes.
- To compare CMR with other alternative cardiac imaging modalities (i.e., echocardiography or SPECT) on prognostic prediction in NSTEMI patients.
- To compare myocardial tissue characteristics and functional changes in STEMI (data derived from EARLY-MYO-CMR) and NSTEMI patients.
- To verify GRACE Score classification in NSTEMI from CMR imaging view.
- Medical subject headings
- Non-ST Elevated Myocardial Infarction
What is being measured
The primary outcome is the main question the study is designed to answer.
Major adverse cardiac events(MACE)
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Jun 2019
- Study start8 May 2012
- Primary completion8 Jul 2019 (estimated)
- Study completion9 Dec 2019 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Non-ST-Segment Elevation Myocardial Infarction (NSTEMI)Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 2,000 participants (estimated)
Sponsor and investigators
- Lead sponsor
- RenJi Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Jun Pu, Principal investigator, Renji Hospital, School of Medicine, Shanghai Jiaotong University.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03995433
- Sponsor's protocol ID
- EARLY-MYO-CMR-II
- Status last verified
- Jun 2019
- First submitted
- 20 Jun 2019
- Last updated
- 24 Jun 2019
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 24 Jun 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- EARLY-MYO-CMR-II (EARLY Assessment of MYOcardial Tissue Characteristics by CMR in NSTEMI) Registry
- ClinicalTrials.gov ID
- NCT03995433
- Acronym / sponsor ID
- EARLY-MYO-CMR-II
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 2,000 participants (estimated)
- Lead sponsor
- RenJi HospitalUniversity, hospital or other
- Study start
- 8 May 2012 (actual)
- Primary completion
- 8 Jul 2019 (estimated)
- Study completion
- 9 Dec 2019 (estimated)
- First posted
- 24 Jun 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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:
- To investigate myocardial pathological features and functional changes in NSTEMI patients.
- To identify CMR-derived indices that are associated with adverse clinical outcomes.
- To compare CMR with other alternative cardiac imaging modalities (i.e., echocardiography or SPECT) on prognostic prediction in NSTEMI patients.
- To compare myocardial tissue characteristics and functional changes in STEMI (data derived from EARLY-MYO-CMR) and NSTEMI patients.
- To verify GRACE Score classification in NSTEMI from CMR imaging view.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- NSTEMI patients undergo CMR examination are eligible for this registry.
Key inclusion criteria (7 listed)
- 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):
- Ischemic symptoms (chest pain or equivalent) at rest ≥ 10 minutes within 24 hours of randomization,
- One of the two following criteria:
- Patients who have had CMR imaging performed and have agreed to comply with the follow up requirements.
Key exclusion criteria (3 listed)
- Patient who is unable to comply with the follow-up schedule.
- Patient who has any medical conditions that in the opinion of the investigators will not be appropriate to participate in the study.
- Patient has a life expectancy of less than 6 months due to any condition.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Major adverse cardiac events(MACE)
Time frame: 1 year
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Jun 2019.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jun Pu principal investigator
Renji Hospital, School of Medicine, Shanghai Jiaotong University.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Non-ST-Segment Elevation Myocardial Infarction (NSTEMI), run by RenJi Hospital at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 24 Jun 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Jun Pu (08602168383164, pujun310@hotmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Major adverse cardiac events(MACE) (time frame: 1 year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Jun 2019.