Tokyo, Aug. 9 -- UMIN Clinical Trials Registry (UMIN-CTR) received information related to the study (UMIN000058733) titled 'Findings of long-time recorded electrocardiograms and prognosis in patients with myocardial infarction study (FIRE-MI Registry)' on Aug. 8.
Study Type:
Observational
Primary Sponsor:
Institute - Jichi Medical University School of Medicine
Condition:
Condition - Patients who had suffered from a myocardial infarction
Classification by malignancy - Others
Genomic information - NO
Objective:
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
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 Size - 210
Recruitment Status:
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
To know more, visit https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000067160
Disclaimer: Curated by HT Syndication.