CClinicalTrials.gg
Status unknownNCT04338113Updated Apr 8, 2020

EARLY-MYO-Myocarditis Registry

An observational study in Myocarditis, sponsored by RenJi Hospital. Status unknown at 1 site in China. Open to participants aged 18 Years to 75 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2020-04-08.

Sponsored by RenJi Hospital · Observational

The sponsor has not verified this record recently (last verified Apr 2020), so the status shown — last known as Recruiting — may be out of date.
Study type
Observational
Model
Case-only
Time perspective
Prospective
Enrollment
200
Ages
18 Years to 75 Years
Sex
All
01

Study 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. 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:

  1. To investigate myocardial tissue features and functional changes in patients with myocarditis.
  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 patients with myocarditis.
02

Conditions studied

  • Myocarditis

Browse trials for

03

In context

Myocarditis

164 studies on the registry are indexed under Myocarditis; 71 are open to participants now.

This study's planned enrollment of 200 is below the median of 226 across 115 observational studies indexed under Myocarditis.

Browse Myocarditis studies →

Lead sponsor

RenJi Hospital is the lead sponsor of 535 studies on the registry; 244 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 75 Years
Sexes eligible
All
Accepts healthy volunteers
Yes
Sampling method
Non-probability sample

Study population

Patients with myocarditis undergo CMR examination are eligible for this registry.

Eligibility criteria

[Inclusion Criteria]:

  1. 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.
  2. 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]:

  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.
05

Study design

Observational model
Case-only
Time perspective
Prospective
Enrollment
200 participants (estimated)
Target follow-up
5 Years
Patient registry
Yes
06

What researchers measure

Primary outcomes

  1. Composite outcomes of adverse cardiac events

    cardiac death,sudden deatch, malignant arrhythmias,heart failure and etc.

    Time frame: 1 year

07

Study locations

1 of 1 sites recruiting
  • Ren Ji Hospital Affliated to School of Medicine, Shanghai Jiao Tong University
    Shanghai, Shanghai 200127, China
    Recruiting
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Apr 8, 2020, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT04338113
Lead sponsor
RenJi Hospital
Responsible party
Sponsor
First posted
Apr 8, 2020
Start date
Jan 1, 2020
Primary completion
Jan 1, 2025 (estimated)
Completion
Jan 1, 2025 (estimated)
Last update
Apr 8, 2020

Study contacts

Jun Pu
Contact
pujun310@hotmail.com
08602168383164
Jun Pu
principal investigator · Renji Hospital, School of Medicine, Shanghai Jiaotong University

Oversight

FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is status unknown, as verified in Apr 2020. You cannot join it, but the record below documents what was studied.

Follow this study

Get an email when the registry record changes — status, dates, results — or when someone posts here.

Sign in to follow

Discussion

Questions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.

Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.

Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.

Start the discussion