UMIN-ICDS Clinical Trial
| Unique ID issued by UMIN | UMIN000053628 |
|---|---|
| Receipt number | R000061194 |
| Scientific Title | The prevalence and clinical prognosis of myocardial infarction with non-obstructive coronary arteries: a prospective multicenter observational study (REVEIL-MINOCA study) |
| Date of disclosure of the study information | 2024/02/16 |
| Last modified on | 2024/02/15 22:40:36 |
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Basic information
Public title
The prevalence and clinical prognosis of myocardial infarction with non-obstructive coronary arteries: a prospective multicenter observational study (REVEIL-MINOCA study)
Acronym
REVEIL-MINOCA study
Scientific Title
The prevalence and clinical prognosis of myocardial infarction with non-obstructive coronary arteries: a prospective multicenter observational study (REVEIL-MINOCA study)
Scientific Title:Acronym
REVEIL-MINOCA study
Region
| Japan |
Condition
Condition
Acute coronary syndrome
Classification by specialty
| Cardiology |
Classification by malignancy
Others
Genomic information
YES
Objectives
Narrative objectives1
The purpose of this study is to understand the current status and prognosis of MINOCA.
Specifically, it will focus on
Elucidation of epidemiological features of MINOCA
In this study, we will clarify the epidemiological characteristics of MINOCA, including the incidence of MINOCA, the age/gender distribution of patients, coexisting risk factors and their relevance to INOCA, and gain a more detailed understanding of the spread of MINOCA and associated factors.
Elucidation of clinical features of MINOCA
To investigate the pathophysiological features of MINOCA patients, including clinical features, symptom severity, electrocardiogram findings, and cardiovascular biomarker abnormalities. To clarify the clinical picture of MINOCA and contribute to the improvement of differential diagnosis from other cardiovascular diseases.
Prognostic assessment of MINOCA
In this study, we will assess the long-term outcome of patients with MINOCA and follow prognostic events such as recurrent myocardial infarction, cardiovascular events, heart failure, and death. It will contribute to the establishment of prognostic factors and risk assessment strategies for MINOCA patients.
Planning MINOCA's management strategy
We aim to develop an evidence-based approach based on study results to establish appropriate management strategies for MINOCA patients.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Incidence of major cardiovascular events in MINOCA and non-MINOCA cases at 1 year follow-up
MACCE, major adverse cardiovascular and cerebrovascular event. composite endpoint of all-cause mortality, myocardial infarction, revascularization, stroke, systemic embolism, heart failure readmission
Key secondary outcomes
Secondary endpoints
Rate of MINOCA cases to all enrolled ACS cases
Breakdown by onset mechanism in MINOCA cases
The incidence of MACCE events over time in MINOCA and non-MINOCA cases
MACCE, major adverse cardiovascular and cerebrovascular event.composite endpoint of all-cause death, myocardial infarction, revascularization, stroke, systemic embolism, heart failure readmission
Incidence of MACCE items over time in MINOCA and non-MINOCA cases
Incidence of the following clinical outcomes over time in MINOCA and non-MINOCA cases
Death
Myocardial infarction
Stent thrombosis
Revascularization
Emergency revascularization
Bleeding events
Stroke
Systemic embolism
Ischemic cardiomyopathy
Hospitalization for heart failure
Other all endpoints defined in ARC-25
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 diagnosed with ACS who visited or were admitted hospitals in this study between study initiation and March 2028 and who meet the following eligibility criteria and do not meet any of the exclusion criteria.
Eligibility criteria
Patients undergoing emergency coronary angiography for the diagnosis of acute coronary syndrome, including unstable angina, ST-segment elevation myocardial infarction, non-ST-segment elevation myocardial infarction
Patients who are 18 years of age or older
Patients who can be followed up regularly once a year
Key exclusion criteria
Exclusion criteria
Patients who declared non-participation in the study
Patients who are regarded as inappropriate to participate in the study by the investigators
Target sample size
5000
Research contact person
Name of lead principal investigator
| 1st name | Yasushi |
| Middle name | |
| Last name | Sakata |
Organization
Graduate School of Medicine, Osaka University
Division name
Department of Cardiovascular Medicine
Zip code
565-0871
Address
2-15 Yamadaoka, Suita, Osaka, Japan
TEL
06-6879-3631
sakata.yasushi.med@osaka-u.ac.jp
Public contact
Name of contact person
| 1st name | Yohei |
| Middle name | |
| Last name | Sotomi |
Organization
Osaka University Graduate School of Medicine
Division name
Department of Cardiovascular Medicine
Zip code
565-0871
Address
2-15 Yamadaoka, Suita, Osaka, Japan
TEL
06-6879-3631
Homepage URL
sotomiyohei@gmail.com
Sponsor or person
Institute
Osaka University Graduate School of Medicine
Institute
Department
Personal name
Funding Source
Organization
Abbott Medical Japan
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
Oaka university medical hospital
Address
2-2 Yamadaoka, Suita, Osaka, Japan
Tel
06-6210-8290
jim-chiken@hp-crc.med.osaka-u.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
Osaka University Hospital、Osaka Rosai Hospital、Kinki Central Hospital、Higashiosaka City Medical Center、
Sakai Medical Center、Minoh City Hospital、Osaka Police Hospital、NHO Osaka Minami Medical Center、
Kansai Rosai Hospital、Sumitomo Hospital、Osaka General Medical Center、
Japan Community Heath care Organization Osaka Hospital、Suita Municipal Hospital、
Kawanishi City General Medical Center、Hyogo Prefectural Nishinomiya Hospital、
Japan Community Heath care Organization Osaka Minato Central Hospital、NHO Osaka Medical Center、
Rinku General Medical Center、Amagasaki Chuo Hospital、Saiseikai Senri Hospital、Yao Municipal Hospital、
Toyonaka Municipal Hospital、Sakurabashi Watanabe Hospital、Kawasaki Hospital、Kobe Ekisaikai Hospital、
Ikeda City Hospital
Other administrative information
Date of disclosure of the study information
| 2024 | Year | 02 | Month | 16 | 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
Preinitiation
Date of protocol fixation
| 2023 | Year | 08 | Month | 01 | Day |
Date of IRB
| 2023 | Year | 07 | Month | 27 | Day |
Anticipated trial start date
| 2024 | Year | 02 | Month | 16 | Day |
Last follow-up date
| 2031 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
This study is a planned analysis using data from a portion of the REVEIL-ACS study and will be conducted in a manner that is fully inclusive of the REVEIL-ACS study.
Ethical review of the study has been approved as a REVEIL-ACS study.
Management information
Registered date
| 2024 | Year | 02 | Month | 15 | Day |
Last modified on
| 2024 | Year | 02 | Month | 15 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000061194
| Research Plan | |
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| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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