Tokyo, June 9 -- UMIN Clinical Trials Registry (UMIN-CTR) received information related to the study (UMIN000061832) titled 'Real-world Evaluation of GDMTImplementation and Long-term Outcomesin Patients With Acute Myocardial Infarction:A Multicenter, Prospective Registry FromIWAte Medical University Affiliated Hospitals(REIWA Registry Cohort-2)' on June 9.
Study Type:
Observational
Primary Sponsor:
Institute - Iwate Medical University
Condition:
Condition - Acute myocardial infarction, including ST-elevation myocardial infarction and non-ST-elevation myocardial infarction
Classification by malignancy - Others
Genomic information - NO
Objective:
Narrative objectives1 - This study aims to evaluate the feasibility of implementing guideline-directed, state-of-the-art secondary prevention therapy, particularly intensive lipid management targeting LDL-C <55 mg/dL, in patients with acute myocardial infarction diagnosed at Iwate Medical University affiliated hospitals and related institutions. The study will also assess the association between treatment implementation/target achievement and 2-year clinical outcomes.
Basic objectives2 - Others
Eligibility:
Age-lower limit - 18
years-old
<=
Age-upper limit - Not applicable
Gender - Male and Female
Key inclusion criteria - Patients meeting all of the following criteria will be eligible: 1) age 18 years or older at the time of consent; 2) diagnosis of spontaneous acute myocardial infarction(type 1 MI) as the index event at a participating institution during the enrollment period; 3) STEMI or NSTEMI; and 4) written informed consent for study participation. If obtaining consent from the patient is difficult in the acute phase, consent may be obtained from a legally acceptable representative, followed by patient consent at a later date. Patients will be included regardless of acute treatment strategy, including PCI, CABG, or conservative management.
Key exclusion criteria - Patients meeting any of the following criteria will be excluded: 1) acute or chronicmyocardial injury not considered acutemyocardial infarction; 2) type 2 MI mainly caused by oxygen supply-demandmismatch; 3) procedure-related MI, including type 4a, 4b, 4c, or 5 MI; 4) cases not considered spontaneous AMI causedmainly by coronary plaque rupture or erosion based on the clinical course, imaging findings, or coronary findings; and 5) suspected non-ischemic myocardial injury, including myocarditis, takotsubo syndrome, worsening heart failure, pulmonary embolism, sepsis, or myocardial injury associated with severe renal dysfunction.
Target Size - 800
Recruitment Status:
Recruitment status - Open public recruiting
Date of protocol fixation - 2026 Year 01 Month 08 Day
Date of IRB - 2026 Year 02 Month 26 Day
Anticipated trial start date - 2026 Year 06 Month 01 Day
Last follow-up date - 2030 Year 05 Month 31 Day
To know more, visit https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000070755
Disclaimer: Curated by HT Syndication.