MyocarditisNCT04338113
EARLY-MYO-Myocarditis Registry
An observational study of Myocarditis, run by RenJi Hospital at 1 site in China.
Trial summary
The purpose of this registry is to depict the myocardial tissue characteristics in patients with myocarditis by CMR and other cardiac imaging modalities and to assess the prognostic value of imaging-derived indices. Information will be collected prospectively in about 200 patients with myocarditis in 5 sites. Read more about this study
- Who is it for?
- Ages 18 to 75 yearsHealthy volunteers can take part
- Conditions the study is for
- Myocarditis
- How many people
- 200 participants
- Where
- 1 siteChina
- Study dates
- 1 Jan 2020to 1 Jan 2025
- How long will I take part?
- 5 Years
- 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 to 75 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Patients with myocarditis undergo CMR examination are eligible for this registry.
[Inclusion Criteria]:
- Definitive diagnosis of myocarditis - A definitive diagnosis of myocarditis is based upon identification of diagnostic findings on EMB, including histology (Dallas criteria) as well as immunohistochemical stains.
- Criteria for clinically suspected myocarditis - We adopted the 2013 European Society of Cardiology (ESC) position statement criteria for "clinically suspected" myocarditis, which require that a patient have at least one of the following clinical presentations of myocarditis and at least one diagnostic criteria; if the patient is asymptomatic at least two diagnostic criteria are required. A diagnosis of clinically suspected myocarditis also generally requires the absence of other clinical conditions that could explain the clinical findings such as cardiovascular disease (eg, angiographically significant CAD [coronary stenosis ≥50%], valve disease, or congenital heart disease), or an extra-cardiac condition (eg, hyperthyroidism). While it is possible to make a diagnosis of "clinically suspected" myocarditis in a patient with a concomitant condition such as CAD, clinical findings must be carefully reviewed to determine whether findings can be explained by a single disease process or whether the patient likely has at least two separate conditions. Clinical suspicion is higher with greater numbers of fulfilled criteria unrelated to other conditions .
- Clinical presentations:
- Acute chest pain (pericarditis or pseudo-ischemic)
- New-onset (days up to three months) or worsening of dyspnea at rest or exercise, and/or fatigue, with or without left and/or right HF signs
- Palpitation, and/or unexplained arrhythmia symptoms and/or syncope, and/or aborted sudden cardiac death
- Unexplained cardiogenic shock
- Diagnostic criteria:
- ECG/Holter stress test features - New 12-lead ECG and/or Holter and/or stress testing abnormalities with any of the following: first to third degree atrioventricular (AV) block or bundle branch block, ST/T wave change (ST elevation or T wave inversion), sinus arrest, ventricular tachycardia or fibrillation, asystole, atrial fibrillation, significantly reduced R wave height, intraventricular conduction delay (widened QRS complex), abnormal Q waves, low voltage, frequent premature beats, or supraventricular tachycardia.
- Elevated troponin T or troponin I.
- Functional and structural abnormalities on cardiac imaging (echocardiogram, angiogram, or CMR) - New, otherwise unexplained abnormality of LV and/or RV function (regional wall motion abnormality or global systolic or diastolic dysfunction); such abnormality may occur with or without one or more of the following: ventricular dilatation, increased ventricular wall thickness, pericardial effusion or intracavitary thrombus.
- Tissue characterization by CMR - Late gadolinium enhancement (LGE) and/or findings consistent with edema in pattern suggestive of myocarditis. (See 'Cardiovascular magnetic resonance' below.)
- The following ancillary features support the clinical suspicion of myocarditis:
- Fever ≥38.0 degrees C at presentation or during the preceding 30 days with our without associated symptoms (eg, chills, headache, myalgias, malaise, decreased appetite, nausea, vomiting, or diarrhea).
- Prior clinical suspected or definite myocarditis.
- Exposure to toxic agents.
- Extra-cardiac autoimmune disease.
[Exclusion Criteria]:
- 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, Professor, 86-21-68383477, pujun310@hotmail.com
About this study
Official title: EARLY-MYO-Myocarditis (EARLY Assessment of MYOcardial Tissue Characteristics by CMR in Myocarditis) Registry
The purpose of this registry is to depict the myocardial tissue characteristics in patients with myocarditis by CMR and other cardiac imaging modalities and to assess the prognostic value of imaging-derived indices. Information will be collected prospectively in about 200 patients with myocarditis in 5 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 patients with myocarditis 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 200 patients with myocarditis in 5 sites with follow-ups of up to 5 years.
The aim of the project will be as following:
- To investigate myocardial tissue features and functional changes in patients with myocarditis.
- 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 patients with myocarditis.
- Conditions
- Myocarditis
- Medical subject headings
- Myocarditis
What is being measured
The primary outcome is the main question the study is designed to answer.
Composite outcomes of adverse cardiac events
cardiac death,sudden deatch, malignant arrhythmias,heart failure and etc.
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 posted8 Apr 2020
- Study start1 Jan 2020
- Primary completion1 Jan 2025 (estimated)
- Study completion1 Jan 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for MyocarditisStudies of the same condition, open and under way.
- More trials run by RenJi HospitalThe sponsor's other registered studies.
- 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
- 200 participants (estimated)
- Target duration
- 5 Years
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
- NCT04338113
- Sponsor's protocol ID
- EARLY-MYO-Myocarditis
- Status last verified
- Apr 2020
- First submitted
- 5 Apr 2020
- Last updated
- 8 Apr 2020
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Apr 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- EARLY-MYO-Myocarditis (EARLY Assessment of MYOcardial Tissue Characteristics by CMR in Myocarditis) Registry
- ClinicalTrials.gov ID
- NCT04338113
- Acronym / sponsor ID
- EARLY-MYO-Myocarditis
- Conditions
- Myocarditis
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- RenJi HospitalUniversity, hospital or other
- Study start
- 1 Jan 2020 (actual)
- Primary completion
- 1 Jan 2025 (estimated)
- Study completion
- 1 Jan 2025 (estimated)
- First posted
- 8 Apr 2020 (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 patients with myocarditis by CMR and other cardiac imaging modalities and to assess the prognostic value of imaging-derived indices. Information will be collected prospectively in about 200 patients with myocarditis in 5 sites. Subjects will be followed for up to 5 years.
Detailed description
This is a prospective, multi-center, non-randomized, observational registry study of patients with myocarditis 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 200 patients with myocarditis in 5 sites with follow-ups of up to 5 years.
The aim of the project will be as following:
- To investigate myocardial tissue features and functional changes in patients with myocarditis.
- 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 patients with myocarditis.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
- Target follow-up
- 5 Years
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Patients with myocarditis undergo CMR examination are eligible for this registry.
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
Composite outcomes of adverse cardiac events
Time frame: 1 year
cardiac death,sudden deatch, malignant arrhythmias,heart failure and etc.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Apr 2020.
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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 Myocarditis, 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?
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 8 Apr 2020. 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?
Composite outcomes of adverse cardiac events (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 8 Apr 2020.