UMIN-ICDS Clinical Trial
| Unique ID issued by UMIN | UMIN000049942 |
|---|---|
| Receipt number | R000056882 |
| Scientific Title | Time from acute percutaneous coronary angioplasty to maximum serum CK-MB level and clinical outcome in patients with acute myocardial infarction |
| Date of disclosure of the study information | 2022/12/28 |
| Last modified on | 2022/12/28 21:41:42 |
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Basic information
Public title
Prognostic Implications of Time between Balloon to Peak Creatinine Kinase-MB in patients with Acute Myocardial Infarction Undergoing Primary PCI: Multicenter Cohort Study
Acronym
Prognostic Implications of Time between Balloon to Peak Creatinine Kinase-MB in patients with Acute Myocardial Infarction Undergoing Primary PCI: Multicenter Cohort Study
Scientific Title
Time from acute percutaneous coronary angioplasty to maximum serum CK-MB level and clinical outcome in patients with acute myocardial infarction
Scientific Title:Acronym
Time from acute percutaneous coronary angioplasty to maximum serum CK-MB level and clinical outcome in patients with acute myocardial infarction
Region
| Japan |
Condition
Condition
acute myocardial infarction
Classification by specialty
| Cardiology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To evaluate prognostic implication of time between Balloon to Peak CK-MB in acute myocardial infarction patients undergoing primary percutaneous coronary intervention.
Basic objectives2
Others
Basic objectives -Others
To observe the prognostic impact of time from balloon to peak CK-MB in AMI patients undergoing PCI
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
cardiovascular death at 1 year
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
| Not applicable |
Gender
Male and Female
Key inclusion criteria
Patients with acute myocardial infarction undergoing primary percutaneous coronary intervention
Key exclusion criteria
(1) did not undergo primary PCI, (2) the onset of AMI is unknown, and (3) plasma CK levels were already at peak at admission.
Target sample size
1000
Research contact person
Name of lead principal investigator
| 1st name | Nobuhisa |
| Middle name | |
| Last name | Hagiwara |
Organization
Department of Cardiology, Tokyo Womens Medical University, Tokyo, Japan
Division name
Cardiology
Zip code
162-8666
Address
8-1 Kawadacho, Shinjuku-ku, Tokyo, Japan
TEL
03-3353-8111
hagiwara.nobuhisa@twmu.ac.jp
Public contact
Name of contact person
| 1st name | Eiji |
| Middle name | |
| Last name | Shibahashi |
Organization
Department of Cardiology, Tokyo Womens Medical University, Tokyo, Japan
Division name
Cardiology
Zip code
162-8666
Address
8-1 Kawadacho, Shinjuku-ku, Tokyo, Japan
TEL
03-3353-8111
Homepage URL
shibahashi.e@gmail.com
Sponsor or person
Institute
Department of Cardiology, Tokyo Womens Medical University, Tokyo, Japan
Institute
Department
Personal name
Funding Source
Organization
None
Organization
Division
Category of Funding Organization
Self funding
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Tokyo Womens Medical University
Address
8-1 Kawadacho, Shinjuku-ku, Tokyo, Japan
Tel
03-3353-8111
N/A
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
| 2022 | Year | 12 | Month | 28 | 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
1416
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
No longer recruiting
Date of protocol fixation
| 2017 | Year | 09 | Month | 01 | Day |
Date of IRB
| 2017 | Year | 10 | Month | 26 | Day |
Anticipated trial start date
| 2017 | Year | 11 | Month | 01 | Day |
Last follow-up date
| 2022 | Year | 10 | Month | 01 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
AMI patients in the 8 cardiovascular centers in Japan between April 2011 and April 2017
Management information
Registered date
| 2022 | Year | 12 | Month | 28 | Day |
Last modified on
| 2022 | Year | 12 | Month | 28 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000056882
| 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 |
