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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000010903
Receipt No. 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

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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
Last 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
Email yoshino@kskyorin-u.ac.jp

Public contact
1st 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
Email tanny@ks.kyorin-u.ac.jp

Sponsor
Institute Kyorin University School of Medicine, Second department of Internal Medicine
Institute
Department

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
Email

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
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000012758

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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