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Clinical Assessment of New Treatment Regimen for Adult Fulminant Myocarditis

Sponsor
Tongji Hospital (Other)
Overall Status
Unknown status
CT.gov ID
NCT03268642
Collaborator
(none)
150
Enrollment
1
Location
70
Duration (Months)
2.1
Patients Per Site Per Month

Study Details

Study Description

Brief 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.

Condition or Disease Intervention/Treatment Phase

    Study Design

    Study Type:
    Observational
    Anticipated Enrollment :
    150 participants
    Observational Model:
    Cohort
    Time Perspective:
    Retrospective
    Official Title:
    Assesment of Clinical Therapeutic Efficacy of "Life-support Based Comprehensive Treatment Regimen" for Adult Fulminant Myocarditis
    Study Start Date :
    Feb 1, 2016
    Anticipated Primary Completion Date :
    Dec 1, 2020
    Anticipated Study Completion Date :
    Dec 1, 2021

    Arms and Interventions

    Arm Intervention/Treatment
    Life-support Based Comprehensive Treatment Regimen group

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

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

    Outcome Measures

    Primary Outcome Measures

    1. death or cardiac transplantation [through hospital discharge, an average of 10 days]

      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.

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    16 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    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:

    • 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.

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Tongji Hospital Wuhan Hubei China 430030

    Sponsors and Collaborators

    • Tongji Hospital

    Investigators

    • Principal Investigator: Dao Wen Wang, Doctor, Tongji Hospital

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Dao Wen Wang, Principal Investigator, Tongji Hospital
    ClinicalTrials.gov Identifier:
    NCT03268642
    Other Study ID Numbers:
    • TJH-C20160202
    First Posted:
    Aug 31, 2017
    Last Update Posted:
    Mar 12, 2020
    Last Verified:
    Mar 1, 2020
    Keywords provided by Dao Wen Wang, Principal Investigator, Tongji Hospital
    Fulminant Myocarditis
    Retrospective cohort study
    Additional relevant MeSH terms:
    Myocarditis

    Study Results

    No Results Posted as of Mar 12, 2020