UMIN-ICDS Clinical Trial
| Unique ID issued by UMIN | UMIN000061832 |
|---|---|
| Receipt number | R000070755 |
| Scientific Title | 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) |
| Date of disclosure of the study information | 2026/06/09 |
| Last modified on | 2026/06/08 17:54:47 |
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Basic information
Public title
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)
Acronym
REIWA Registry Cohort-2
Scientific Title
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)
Scientific Title:Acronym
REIWA Registry Cohort-2
Region
| Japan |
Condition
Condition
Acute myocardial infarction, including ST-elevation myocardial infarction and non-ST-elevation myocardial infarction
Classification by specialty
| Cardiology |
Classification by malignancy
Others
Genomic information
NO
Objectives
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
Basic objectives -Others
Observational evaluation of GDMT implementation, LDL-C target achievement, and long-term outcomes after acute myocardial infarction
Trial characteristics_1
Confirmatory
Trial characteristics_2
Pragmatic
Developmental phase
Not applicable
Assessment
Primary outcomes
Two-year 4-point major adverse cardiac and cerebrovascular events (4P-MACE), defined as a composite of all-cause death, myocardial infarction, stroke, and unplanned revascularization.
Key secondary outcomes
Key secondary outcomes include 3-point hard MACE (all-cause death, non-fatal myocardial infarction, and non-fatal stroke), MACE including heart failure hospitalization(all-cause death, non-fatal myocardial infarction, non-fatal stroke, heart failure hospitalization, and unplanned revascularization), each component of the primary composite endpoint, bleeding events defined as BARC criteria, LDL-C target achievement rates at 1, 6, 12, and 24 months, and adverse events and discontinuation of PCSK9 inhibitors.
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
| 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 sample size
800
Research contact person
Name of lead principal investigator
| 1st name | Kai |
| Middle name | |
| Last name | Ninomiya |
Organization
Iwate Medical University
Division name
Division of Cardiology, Department of Internal Medicine
Zip code
028-3695
Address
2-1-1 Idaidori, Yahaba-cho, Shiwa-gun,Iwate 028-3695, Japan
TEL
019-613-7111
kn.ipc0325@gmail.com
Public contact
Name of contact person
| 1st name | Kai |
| Middle name | |
| Last name | Ninomiya |
Organization
Iwate Medical University
Division name
Division of Cardiology, Department of Internal Medicine
Zip code
028-3695
Address
2-1-1 Idaidori, Yahaba-cho, Shiwa-gun,Iwate 028-3695, Japan
TEL
019-613-7111
Homepage URL
kn.ipc0325@gmail.com
Sponsor or person
Institute
Iwate Medical University
Institute
Department
Personal name
Kai Ninomiya
Funding Source
Organization
none
Organization
Division
Category of Funding Organization
Other
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Iwate Medical University
Address
2-1-1 Idaidori, Yahaba-cho, Shiwa-gun,Iwate 028-3695, Japan
Tel
019-613-7111
kn.ipc0325@gmail.com
Secondary IDs
Secondary IDs
NO
Study ID_1
Org. issuing International ID_1
Study ID_2
Org. issuing International ID_2
IND to MHLW
Galway
Institutions
Institutions
Other administrative information
Date of disclosure of the study information
| 2026 | Year | 06 | Month | 09 | 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
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 |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
none
Management information
Registered date
| 2026 | Year | 06 | Month | 08 | Day |
Last modified on
| 2026 | Year | 06 | Month | 08 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000070755
