UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000058733 |
|---|---|
| Receipt number | R000067160 |
| Scientific Title | Findings of long-time recorded electrocardiograms and prognosis in patients with myocardial infarction study (FIRE-MI Registry) |
| Date of disclosure of the study information | 2025/08/08 |
| Last modified on | 2025/08/08 11:08:13 |
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Basic information
Public title
Findings of long-time recorded electrocardiograms and prognosis in patients with myocardial infarction study (FIRE-MI Registry)
Acronym
Findings of long-time recorded electrocardiograms and prognosis in patients with myocardial infarction study (FIRE-MI Registry)
Scientific Title
Findings of long-time recorded electrocardiograms and prognosis in patients with myocardial infarction study (FIRE-MI Registry)
Scientific Title:Acronym
Findings of long-time recorded electrocardiograms and prognosis in patients with myocardial infarction study (FIRE-MI Registry)
Region
| Japan |
Condition
Condition
Patients who had suffered from a myocardial infarction
Classification by specialty
| Cardiology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
This study aims to clarify the relationship between arrhythmic findings on long-term electrocardiographic recordings and prognosis in patients with myocardial infarction, and to investigate the current status of primary prevention ICD implantation.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Time to major cardiovascular events.
*Major cardiovascular events; a composite of cerebral infarction, cerebral hemorrhage, subarachnoid hemorrhage, unknown type of stroke,
myocardial infarction, cardiovascular intervention due to angina pectoris, and sudden death.
Key secondary outcomes
Time to onset of events and ICD implantation was analyzed. Events included not only major cardiovascular events, but also hospitalizations due to angina, heart failure, and arrhythmias, as well as all-cause mortality.
Base
Study type
Observational
Study design
Basic design
Randomization
Randomization unit
Blinding
Control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
Purpose of intervention
Type of intervention
Interventions/Control_1
Interventions/Control_2
Interventions/Control_3
Interventions/Control_4
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10
Eligibility
Age-lower limit
| 20 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
Patients who meet all of the following conditions:
1. Male or female aged 20 years or older
2. Patients at least 90 days after myocardial infarction onset
3. Left ventricular ejection fraction <=35% as measured by echocardiography at least 90 days after myocardial infarction onset
4. Adequate pharmacological therapy has been administered
Key exclusion criteria
Patients who meet any of the following conditions are excluded:
1. Individuals with severe comorbidities (e.g., terminal stage of cancer, active collagen disease, NYHA Class IV heart failure, or expected survival of less than 12 months)
2. Patients with a previously implanted implantable cardioverter-defibrillator (ICD)
3. Patients with alcohol dependence or substance abuse disorders
4. Individuals for whom obtaining informed consent is difficult
5. Patients otherwise considered inappropriate by the physician
Target sample size
210
Research contact person
Name of lead principal investigator
| 1st name | Tomoyuki |
| Middle name | |
| Last name | Kabutoya |
Organization
Jichi Medical University School of Medicine
Division name
Division of Cardiovascular Medicine, Department of Medicine
Zip code
329-0498
Address
3311-1 Yakushiji, Shimotsuke, Tochigi, Japan.
TEL
0285-58-7344
kabu@jichi.ac.jp
Public contact
Name of contact person
| 1st name | Tomoyuki |
| Middle name | |
| Last name | Kabutoya |
Organization
Jichi Medical University School of Medicine
Division name
Division of Cardiovascular Medicine, Department of Medicine
Zip code
329-0498
Address
3311-1 Yakushiji, Shimotsuke, Tochigi, Japan.
TEL
0285-58-7344
Homepage URL
firemi25@jichi.ac.jp
Sponsor or person
Institute
Jichi Medical University School of Medicine
Institute
Department
Personal name
Funding Source
Organization
Japan Lifeline Co.,Ltd.
Organization
Division
Category of Funding Organization
Profit organization
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Jichi Medical University Hospital Bioethics Committee for Clinical Research
Address
3311-1 Yakushiji, Shimotsuke, Tochigi, Japan.
Tel
0285-58-8933
rinri@jichi.ac.jp
Secondary IDs
Secondary IDs
NO
Study ID_1
Org. issuing International ID_1
Study ID_2
Org. issuing International ID_2
IND to MHLW
Institutions
Institutions
Other administrative information
Date of disclosure of the study information
| 2025 | Year | 08 | Month | 08 | Day |
Related information
URL releasing protocol
Publication of results
Unpublished
Result
URL related to results and publications
Number of participants that the trial has enrolled
Results
Results date posted
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Participant flow
Adverse events
Outcome measures
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Enrolling by invitation
Date of protocol fixation
| 2025 | Year | 03 | Month | 03 | Day |
Date of IRB
| 2025 | Year | 03 | Month | 03 | Day |
Anticipated trial start date
| 2025 | Year | 08 | Month | 01 | Day |
Last follow-up date
| 2029 | Year | 04 | Month | 30 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
To evaluate the clinical relevance of long-term Holter electrocardiographic screening in patients with reduced cardiac function following myocardial infarction who may be candidates for primary prevention ICD implantation, this study investigates the actual arrhythmic burden and prognosis as recorded by long-term Holter monitoring.
Management information
Registered date
| 2025 | Year | 08 | Month | 08 | Day |
Last modified on
| 2025 | Year | 08 | Month | 08 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000067160
