Multicentre retrospective registry trial of the efficacy and safety of fulminant myocarditis with IMPELLA

Multicentre retrospective registry trial of the efficacy and safety of fulminant myocarditis with IMPELLA - Multicentre retrospective registry trial of the efficacy and safety of fulminant myocarditis with IMPELLA

Status

Active, not recruiting

Phases

Unknown

Study type

Observational

Source

JPRN

Registry ID

JPRN-UMIN000047999

Enrollment

Registered

2022-06-15

Start date

2023-01-31

Completion date

Unknown

Last updated

2026-06-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

fulminant myocarditis

Interventions

None listed

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: Definition of acute myocarditis: cases with elevated serum troponin or serum CK-MB levels in which acute myocardial infarction is ruled out. Description of fulminant myocarditis: cases of acute myocarditis requiring catecholamines or an assistive circulatory device (IABP, PCPS, IMPELLA, assisted artificial heart). Pathological findings are not necessary.

Exclusion criteria

Exclusion criteria: Acute coronary syndromes, under 16 years of age, cases with evident takotsubo cardiomyopathy

Design outcomes

Primary

Measure	Time frame
- All-cause mortality (30-day mortality), cardiac death	—

Secondary

Measure	Time frame
- Rate of MCS (mechanical circulatory support; IABP, ECMO, IMPELLA, left ventricular assist heart) - Stroke - Complications (major haemorrhage, peripheral haemostasis, sepsis, haemolysis) - Survival, length of hospital admission - Date and time of onset - On admission Vital signs, presence of arrhythmia - Admission blood samples (Hb, Ht, eGFR(cre), AST, T. Til, Peak CK/CK-MB), arterial blood gas analysis results - Swan-Ganz catheter findings - Echocardiographic findings - Results of myocardial biopsy - Presence of assisted circulation and timing of its induction (time from shock or admission to assisted circulation)	—

Measure

Time frame

- Rate of MCS (mechanical circulatory support; IABP, ECMO, IMPELLA, left ventricular assist heart) - Stroke - Complications (major haemorrhage, peripheral haemostasis, sepsis, haemolysis) - Survival, length of hospital admission - Date and time of onset - On admission Vital signs, presence of arrhythmia - Admission blood samples (Hb, Ht, eGFR(cre), AST, T. Til, Peak CK/CK-MB), arterial blood gas analysis results - Swan-Ganz catheter findings - Echocardiographic findings - Results of myocardial biopsy - Presence of assisted circulation and timing of its induction (time from shock or admission to assisted circulation)

—

Countries

Japan

Contacts

Public ContactMasaru Ishida

Iwate Medical University Division of Cardiology, Department of Internal Medicine.

maishida@iwate-med.ac.jp+81-019-613-7111

Outcome results