UMIN-ICDS Clinical Trial
| Unique ID issued by UMIN | UMIN000053536 |
|---|---|
| Receipt number | R000060987 |
| Scientific Title | A prospective long-term multi-center observational study for the timely update of optimal social medical system and individualized treatment strategy in patients with acute coronary syndrome: REVEIL-ACS registry |
| Date of disclosure of the study information | 2024/02/16 |
| Last modified on | 2024/02/04 18:26:33 |
* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments
Basic information
Public title
A prospective long-term multi-center observational study for the timely update of optimal social medical system and individualized treatment strategy in patients with acute coronary syndrome: REVEIL-ACS registry
Acronym
REVEIL-ACS registry
Scientific Title
A prospective long-term multi-center observational study for the timely update of optimal social medical system and individualized treatment strategy in patients with acute coronary syndrome: REVEIL-ACS registry
Scientific Title:Acronym
REVEIL-ACS registry
Region
| Japan |
Condition
Condition
Acute coronary syndrome
Classification by specialty
| Cardiology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
In a context of the long-term evolution of treatment for ACS (Acute Coronary Syndrome), a large, multi-center database will be established for updating the optimal therapies in accordance with the time.
The patient background factors, disease state endpoints, prognostic information, etc. will be intensively analyzed, using long-term multi-center large-scale data to:(1)Continuously pursue the optimal invasive treatment and drug therapy(2)Examine the relationship between patient factors and outcomes(3)Consider the optimization of social and healthcare systems(4)Collect the clinical data for social implementation of medical information engineering and artificial intelligence technology.
The aim of this study is to identify findings that will help early diagnosis, early detection, and improved prognosis of patients by conducting multidisciplinary considerations including the above on a long-term basis.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Primary endpoint: Major adverse cardiovascular events at 3 years (MACCE: Composite endpoint of all deaths, myocardial infarction, repeat revascularization, stroke, systemic embolism, and heart failure rehospitalization).
Key secondary outcomes
Incidence of each primary endpoint over time
Incidence of the following clinical outcomes over time
1.Death
2.Myocardial infarction
3.Stent thrombosis
4.Repeat revascularization
5.Emergency revascularization
6.Bleeding events
7.Stroke
8.Systemic embolism
9.Progression to ischemic cardiomyopathy (ICM)
10.Heart failure hospitalization
Incidence of all other endpoints defined in ARC-2
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 to) the hospitals between July 2023 and March 2028 and who meet the following eligibility criteria and do not meet any of the exclusion criteria.
Patients indicated for emergency coronary angiography due to the diagnosis of acute coronary syndrome (unstable angina, ST-segment elevation myocardial infarction, and non-ST-segment elevation myocardial infarction)
Patients aged 18 years or older
Patients who can be followed up regularly once a year
Key exclusion criteria
Patients who declared non-participation in the study
Patients who are regarded as inappropriate to participate in the study by the investigator or subinvestigator
Target sample size
5000
Research contact person
Name of lead principal investigator
| 1st name | Yasushi |
| Middle name | |
| Last name | Sakata |
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
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
sotomi.yohei.med@osaka-u.ac.jp
Sponsor or person
Institute
Osaka University Graduate School of Medicine
Institute
Department
Personal name
Funding Source
Organization
Under negotiation.
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
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
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 | 06 | 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
In this study, observational and investigation items will continue to be updated in an ongoing effort to continuously optimize ACS treatment, which will continue to be updated.
Management information
Registered date
| 2024 | Year | 02 | Month | 04 | Day |
Last modified on
| 2024 | Year | 02 | Month | 04 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000060987
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
|---|---|
| Registered date | File name |
| Research case data | |
|---|---|
| Registered date | File name |
