UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000010903 |
|---|---|
| Receipt number | R000012758 |
| Scientific Title | An Evaluation of Kyorin Cardiovascular Perioperative Screening for Non-Cardiac Surgery |
| Date of disclosure of the study information | 2013/08/01 |
| Last modified on | 2016/06/07 12:03:19 |
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Basic information
Public title
An Evaluation of Kyorin Cardiovascular Perioperative Screening for Non-Cardiac Surgery
Acronym
KCPS study
Scientific Title
An Evaluation of Kyorin Cardiovascular Perioperative Screening for Non-Cardiac Surgery
Scientific Title:Acronym
KCPS study
Region
| Japan |
Condition
Condition
Non cardiac surgery
Classification by specialty
| Cardiology | Surgery in general | Anesthesiology |
| Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To evaluate the advantage of peri-operative screening for non cardiac surgery based on the guideline of ACC/AHA guidelines.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Cardiac death, Sudden death of unknown reason
Key secondary outcomes
Non cardiac death, Non fatal myocardial infarction, Hospitalization for unstable angina, Stroke, Receiving PCI or CABG
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
| 20 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
Patients over 20 years old receiving general anethesia and non cardiac surgery in Kyorin university hospital
Key exclusion criteria
Patients under 19 years old
Target sample size
5000
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Hideaki Yoshino |
Organization
Kyorin University School of Medicine
Division name
Second Internal Medicine
Zip code
Address
20-2 Shinkawa6 Mitaka Tokyo 181-8611 JAPAN
TEL
0422-47-5511
yoshino@kskyorin-u.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Seiichi Taniai |
Organization
Kyorin University School of Medicine
Division name
Second department of Internal Medicine
Zip code
Address
20-2 Shinkawa6 Mitaka Tokyo 181-8611 JAPAN
TEL
0422-47-5511
Homepage URL
tanny@ks.kyorin-u.ac.jp
Sponsor or person
Institute
Kyorin University School of Medicine, Second department of Internal Medicine
Institute
Department
Personal name
Funding Source
Organization
Kyorin University School of Medicine, Second department of Internal Medicine
Organization
Division
Category of Funding Organization
Self funding
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
杏林大学医学部付属病院
Other administrative information
Date of disclosure of the study information
| 2013 | Year | 08 | 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
Completed
Date of protocol fixation
| 2013 | Year | 05 | Month | 24 | Day |
Date of IRB
Anticipated trial start date
| 2013 | Year | 08 | Month | 01 | Day |
Last follow-up date
| 2016 | Year | 04 | Month | 01 | Day |
Date of closure to data entry
| 2016 | Year | 12 | Month | 31 | Day |
Date trial data considered complete
Date analysis concluded
Other
Other related information
We reported the experience and usefulness of Kyorin cardiac perioperative screening for non-cardiacsurgery with the data of 237 patients at the 58th Annual Scientific Session of the Japanese College of Cardiology
Management information
Registered date
| 2013 | Year | 06 | Month | 07 | Day |
Last modified on
| 2016 | Year | 06 | Month | 07 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000012758
| 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 |
