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Status unknownNCT03268642Updated Mar 12, 2020

Clinical Assessment of New Treatment Regimen for Adult Fulminant Myocarditis

An observational study in Fulminant Myocarditis, sponsored by Tongji Hospital. Status unknown at 1 site in China. Open to participants aged 16 Years and older. Per ClinicalTrials.gov, last updated 2020-03-12.

Sponsored by Tongji Hospital · Observational

The sponsor has not verified this record recently (last verified Mar 2020), so the status shown — last known as Recruiting — may be out of date.
Study type
Observational
Model
Cohort
Time perspective
Retrospective
Enrollment
150
Ages
16 Years and older
Sex
All
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Study summary

This is a retrospective cohort study to assess the clinical outcome of patients with fulminant myocarditis using "Life-support Based Comprehensive Treatment Regimen" and conventional therapy. In the present study, participants receive various treatment as part of routine medical care without any assignment of specific interventions to them. The process of treatment during hospitalization were recorded in medical chart and was reviewed by independent research personnel.

02

Conditions studied

  • Fulminant Myocarditis

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Keywords

  • Fulminant Myocarditis
  • Retrospective cohort study
03

Who can participate

Ages eligible
16 Years and older
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Non-probability sample

Study population

150 hospitalized patients with fulminant myocarditis will be enrolled in this study.

Inclusion criteria

  • 16 years of age or older;

  • Diagnosed as fulminant myocarditis:

    • Evidence of myocarditis on biopsy or increased biomarkers of myocardial injury (TNI and CK-MB and BNP or NT-pro-BNP);
    • Acute onset of symptoms of cardiac dysfunction: dyspnea, palpation, chest pain, and/or syncope;
    • Image for cardiac injury: marked diffused reduction in left ventricle wall movement, with dramatically decreased left ventricle ejection fraction (LVEF) \< 45%;
    • Cardiogenic shock, e.g., systolic blood pressure ≤90 mmHg or mean arterial pressure \< 70mm Hg or a systolic blood pressure decrease > 40 mm Hg, which is associated with the signs of hypofusion: cyanosis, cold extremities, oliguria, and/or changes in mental status.

Exclusion criteria

Exclusion Criteria:

  • Also considering acute coronary syndrome but unable to perform coronary angiography to distinguish acute coronary syndrome from fulminant myocarditis;
  • Myocardial injury caused by sepsis, chemotherapeutical agents, or poisons;
  • Unstable hemodynamics or shock caused by hypovolemia.
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Study design

Observational model
Cohort
Time perspective
Retrospective
Enrollment
150 participants (estimated)
Patient registry
No

Groups and cohorts

  • Life-support Based Comprehensive Treatment Regimen group

    meet all the following conditions: 1. intravenous immune globulin; 2. large dose of glucocorticoids; 3. mechanical ventilation; 4. hemodynamic support: intra-aortic balloon pump (IABP) or/and extracorporeal membrane oxygenation (ECMO); 5. continuous renal replacement therapy.

  • conventional therapy group

    meet one of the following conditions: 1. without/insufficient intravenous immune globulin; 2. without/with various doses of glucocorticoid ; 3. vasoactive drug; 4. without/delayed mechanical ventilation; 5. without/delayed hemodynamic support; 6. without/delayed continuous renal replacement therapy.

05

What researchers measure

Primary outcomes

  1. death or cardiac transplantation

    The occurrence of death or cardiac transplantation was determined through direct contact with the patient or the family of the patient or review of the patient's medical record.

    Time frame: through hospital discharge, an average of 10 days

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Study locations

1 of 1 sites recruiting
  • Tongji Hospital
    Wuhan, Hubei 430030, China
    Recruiting
07

References and documents

Publications

  • Wang J, He M, Li H, Chen Y, Nie X, Cai Y, Xie R, Li L, Chen P, Sun Y, Li C, Yu T, Zuo H, Cui G, Miao K, Zhao C, Jiang J, Heidecker B, Barnett O, Maisel A, Chen C, Wang DW. Soluble ST2 Is a Sensitive and Specific Biomarker for Fulminant Myocarditis. J Am Heart Assoc. 2022 Apr 5;11(7):e024417. doi: 10.1161/JAHA.121.024417. Epub 2022 Apr 4. PubMed 35377184 ↗
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Registry details

Key details

Study ID
NCT03268642
Lead sponsor
Tongji Hospital
Responsible party
Dao Wen Wang (Principal Investigator, Tongji Hospital) — Principal investigator
First posted
Aug 31, 2017
Start date
Feb 1, 2016
Primary completion
Dec 2020 (estimated)
Completion
Dec 2021 (estimated)
Last update
Mar 12, 2020

Study contacts

Yang Sun, MD candidate
Contact
d201578301@hust.edu.cn
86-27-83663280
Dao Wen Wang, Doctor
principal investigator · Tongji Hospital
View the source record on ClinicalTrials.gov ↗

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

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