UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000008708 |
|---|---|
| Receipt number | R000010234 |
| Scientific Title | Multicenter Registry Study of Out-of-Hospital Cardiac Arrest Survivors Who Complicated by Coronary Vasospasm |
| Date of disclosure of the study information | 2012/09/30 |
| Last modified on | 2012/08/17 12:27:45 |
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Basic information
Public title
Multicenter Registry Study of Out-of-Hospital Cardiac Arrest Survivors Who Complicated by Coronary Vasospasm
Acronym
Registry Study of OHCA Survivors with VSA
Scientific Title
Multicenter Registry Study of Out-of-Hospital Cardiac Arrest Survivors Who Complicated by Coronary Vasospasm
Scientific Title:Acronym
Registry Study of OHCA Survivors with VSA
Region
| Japan |
Condition
Condition
Coronary vasospasm; out-of-hospital cardiac arrest
Classification by specialty
| Cardiology | Emergency medicine |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
We aim to elucidate the clinical characteristics and long-term outcomes of out-of-hospital cardiac arrest survivors complicated by coronary vasospasm and establish useful treatment for them.
Basic objectives2
Others
Basic objectives -Others
Outcome assessment and prognostic stratification
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Major adverse cardiac events (MACE; cardiovascular death, hospitalization due to cardiovascular causes and implantable cardioverter defibrillator-related events)
Key secondary outcomes
All-cause death
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
| Not applicable |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
Patients with coronary vasospasm who developed out-of-hospital cardiac arrest in 1996 or later. The diagnosis of coronary vasospasm is based on the Japanese Circulation Society guideline (JCS2008). Out-of-hispital cardiac arrest includes patients who suffer from ventricular fibrillation, pulseless ventricular tachycardia, pulseless electrical activity and asystole.
Key exclusion criteria
None.
Target sample size
500
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Hiroaki Shimokawa |
Organization
Tohoku University Graduate School of Medicine
Division name
Department of Cardiovascular Medicine
Zip code
Address
1-1 Seiryo-machi, Aoba-ku, Sendai 980-8574, Japan
TEL
022-717-7153
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Jun Takahashi |
Organization
Tohoku University Graduate School of Medicine
Division name
Department of Cardiovascular Medicine
Zip code
Address
1-1 Seiryo-machi, Aoba-ku, Sendai 980-8574, Japan
TEL
022-717-7153
Homepage URL
http://csa.cardiovascular-medicine.jp/
jtakahashi@cardio.med.tohoku.ac.jp
Sponsor or person
Institute
Japanese Coronary Spasm Association
Institute
Department
Personal name
Funding Source
Organization
Japan Heart Foundation
Organization
Division
Category of Funding Organization
Non profit foundation
Nationality of Funding Organization
Japan
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Address
Tel
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
冠攣縮研究会参加施設
Other administrative information
Date of disclosure of the study information
| 2012 | Year | 09 | Month | 30 | 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
| 2012 | Year | 08 | Month | 31 | Day |
Date of IRB
Anticipated trial start date
| 2012 | Year | 10 | Month | 01 | Day |
Last follow-up date
| 2015 | Year | 12 | Month | 31 | Day |
Date of closure to data entry
| 2015 | Year | 12 | Month | 31 | Day |
Date trial data considered complete
Date analysis concluded
Other
Other related information
We plan to observe the clinical characteristics, long-term outcomes and efficacy of treatments in out-of-hospital cardiac arrest survivors complicated by coronary vasospasm.
Management information
Registered date
| 2012 | Year | 08 | Month | 17 | Day |
Last modified on
| 2012 | Year | 08 | Month | 17 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000010234
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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| Registered date | File name |
