UMIN-ICDS Clinical Trial
| Unique ID issued by UMIN | UMIN000062873 |
|---|---|
| Receipt number | R000071978 |
| Scientific Title | Japanese Cardiogenic Shock Care Optimization and Networked Critical-Care Transfer Study |
| Date of disclosure of the study information | 2026/10/01 |
| Last modified on | 2026/09/10 15:28:26 |
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Basic information
Public title
A Study to Improve Cardiogenic Shock Treatment and Transfer to Specialized Hospitals in Japan
Acronym
J-SHOCK CONNECT Study
Scientific Title
Japanese Cardiogenic Shock Care Optimization and Networked Critical-Care Transfer Study
Scientific Title:Acronym
J-SHOCK CONNECT Study
Region
| Japan |
Condition
Condition
Cardiogenic shock
Classification by specialty
| Cardiology | Emergency medicine | Intensive care medicine |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
With an aging patient population, an increasing burden of comorbidities, greater disease severity, and expanding therapeutic options, cardiovascular critical care has become increasingly specialized. Nevertheless, the prognosis of cardiogenic shock remains poor worldwide, with studies from Japan reporting a 30-day mortality rate exceeding 30%. In recent years, regionalization of care through a Hub-and-Spoke model has been proposed as a potential strategy to address shortages of specialized physicians and optimize the delivery of care for critically ill patients. However, no studies have evaluated the effectiveness of such a model in Japan. Therefore, establishing evidence for cardiovascular critical care at the regional healthcare-system level, rather than solely at the individual patient level, is an urgent priority in Japan.
The aim of this study is to (1) evaluate the effectiveness of regionalizing care for critically ill patients through a Hub-and-Spoke model and (2) generate evidence to improve the management and outcomes of patients with cardiogenic shock.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
6-month all-cause mortality and cardiovascular events
Key secondary outcomes
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
| 100 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
The study will include patients aged 18 years or greater with cardiogenic shock or severe heart failure who are admitted to an intensive care unit (ICU), cardiac care unit (CCU), or high care unit (HCU) at a participating institution. Cardiogenic shock will be defined as systolic blood pressure less than 90 mmHg accompanied by evidence of tissue hypoperfusion, including at least one of the following: cold extremities, oliguria, or a serum lactate level 2 mmol/L or higher. Severe heart failure will be defined as heart failure with low cardiac output and/or organ congestion requiring inotropic therapy or mechanical circulatory support.
Key exclusion criteria
Patients aged 18-years or less
Target sample size
600
Research contact person
Name of lead principal investigator
| 1st name | Takahiro |
| Middle name | |
| Last name | Nakashima |
Organization
Kumamoto University
Division name
Department of Cardiovascular Medicine
Zip code
860-8556
Address
1-1-1 Honjo, Kumamoto Chuo-ku, Kumamoto
TEL
096-344-2111
n-takahiro@kumamoto-u.ac.jp
Public contact
Name of contact person
| 1st name | Takahiro |
| Middle name | |
| Last name | Nakashima |
Organization
Kumamoto University
Division name
Department of Cardiovascular Medicine
Zip code
860-8556
Address
1-1-1 Honjo, Kumamoto Chuo-ku, Kumamoto
TEL
096-344-2111
Homepage URL
n-takahiro@kumamoto-u.ac.jp
Sponsor or person
Institute
Kumamoto University
Institute
Department
Personal name
@Hiro_resus
Funding Source
Organization
Kumamoto University
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
Kumamoto University
Address
1-1-1 Honjo, Chuo-ku
Tel
096-344-2111
n-takahiro@kumamoto-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
| 2026 | Year | 10 | Month | 01 | 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
| 2026 | Year | 06 | Month | 12 | Day |
Date of IRB
| 2016 | Year | 06 | Month | 12 | Day |
Anticipated trial start date
| 2026 | Year | 10 | Month | 01 | Day |
Last follow-up date
| 2030 | Year | 12 | 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 | 09 | Month | 10 | Day |
Last modified on
| 2026 | Year | 09 | Month | 10 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000071978
