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Prognostic Factors in Patients with Perioperative Myocardial Injury ; Troponin In NonCardiac Operation ( TINCO )

Status Approved

First Submitted Date

2019/08/14
Registered Date

2019/08/26
Last Updated Date

2019/08/26

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CRIS Required

WHO ICTRP (International Clinical Trial Registry Platform) Required

1. Background

Background - CRIS Registration Number, Unique Protocol ID, Public/Brief Title, Scientific Title, Acronym, MFDS Regulated Study, IND/IDE Protocol, Registered at Other Registry, Name of Registry/Registration Number
CRIS Registration Number	KCT0004244
Unique Protocol ID	SMC 2019-08-048
Public/Brief Title	Troponin In NonCardiac Operation ( TINCO )
Scientific Title	Prognostic Factors in Patients with Perioperative Myocardial Injury ; Troponin In NonCardiac Operation ( TINCO )
Acronym
MFDS Regulated Study	No
IND/IDE Protocol
Registered at Other Registry	No
Healthcare Benefit Approval Status	Not applicable

2. Institutional Review Board / Ethics Committee

Institutional Review Board Information
Board Approval Status	Submitted approval
Board Approval Number	SMC 2019-08-048
Approval Date	2019-08-13
Institutional Review Board Name	Samsung Medical Center Istitutional Review Board
Institutional Review Board Address	81, Irwon-ro, Gangnam-gu, Seoul
Institutional Review Board Telephone	02-3410-2973
Data Monitoring Committee

3. Contact Details

Contact Details Information - Contact Person for Principal Investigator / Scientific Queries, Contact Person for Public Queries, Contact Person for Updating Information의 Name, Title, Email, Telephone, Cellular Phone, Affiliation, Address
Contact Person for Principal Investigator / Scientific Queries
Name	Seung-Hwa Lee
Title	M.D.
Telephone	+82-2-3410-5114
Affiliation	Samsung Medical Center
Address	50, Irwon-Dong, Gangnam-Gu, 135-710, Seoul, Korea.
Contact Person for Public Queries
Name	Jungchan Park
Title	M.D.
Telephone	+82-2-3410-5114
Affiliation	Samsung Medical Center
Address	50, Irwon-Dong, Gangnam-Gu, 135-710, Seoul, Korea.
Contact Person for Updating Information
Name	Kwangmo Yang
Title	M.D.
Telephone	+82-2-3410-5114
Affiliation	Samsung Medical Center
Address	50, Irwon-Dong, Gangnam-Gu, 135-710, Seoul, Korea.

4. Status

Status Information - Study Site, Overall Recruitment Status, Date of First Enrollment, Status of First Enrollment, Target Number of Participant, Primary Completion Date, Recruitment Status by Participating Study Site, Name of Study Site, Recruitment Status, Date of First Enrollment, Status of First Enrollemnt
Recruitment Status by Participating Study Site 1
Study Site	Single
Overall Recruitment Status	Recruiting
Date of First Enrollment	2019-08-14 Actual
Target Number of Participant	45000
Primary Completion Date
Study Completion Date
Name of Study	Samsung Medical Center
Recruitment Status	Recruiting
Date of First Enrollment	2019-08-14 ,

5. Source of Monetary / Material Support

Source of Monetary / Material Support Information - Organization Name, Organization Type, Project ID
1. Source of Monetary/Material Support
Organization Name	Samsung Medical Center
Organization Type	Medical Institute
Project ID

6. Sponsor Organization

Sponsor Organization Information - Organization Name, Organization Type
1. Sponsor Organization
Organization Name	Samsung Medical Center
Organization Type	Medical Institute

7. Study Summary

Study Summary Information
Lay Summary	Troponin I (TnI) is a myocardial enzyme. This is the result of a lab that can see the degree of injury to the heart muscle. If the TnI is increased by more than 0.04, it can be regarded as a patient suffering from myocardial injury before, during, or during surgery. For patients with elevated myocardial enzyme after surgery, we will investigate the basic characteristics of the patient, types of surgery during operation, anesthesia methods, and management methods after surgery. This will contribute to making the prognosis of the patient better by applying it clinically.

Study Summary Information

Lay Summary

Troponin I (TnI) is a myocardial enzyme. This is the result of a lab that can see the degree of injury to the heart muscle. If the TnI is increased by more than 0.04, it can be regarded as a patient suffering from myocardial injury before, during, or during surgery. For patients with elevated myocardial enzyme after surgery, we will investigate the basic characteristics of the patient, types of surgery during operation, anesthesia methods, and management methods after surgery. This will contribute to making the prognosis of the patient better by applying it clinically.

8. Study Design

Study Design Information - Study Type, Observational Study Model, Time Perspective, Target Number of Participant, Cohort/Group Number, Cohort/Group, Cohort/Group Label, Cohort/Group Description, Biospecimen Collection & Archiving, Biospecimen Description
Study Type	Observational Study
Observational Study Model	Cohort
Time Perspective	Prospective
Target Number of Participant	45000
Cohort/Group Number	1
Cohort/ Group 1	Cohort/Group Label Patients who underwent non-cardiac surgery
Cohort/ Group 1	Cohort/Group Description Patients who underwent non-cardiac surgery with pre- or postoperative cardiac troponin in Samsumg medical center from January 2010 to June 2019 to evaluate clinical outcomes according to perioperative cardiac troponin levels
Biospecimen Collection & Archiving	Not collect nor Archive
Biospecimen Description

9. Subject Eligibility

Subject Eligibility Information
Study Population Description	Patients who are undergoing non-cardiac surgery in Samsung medical center
Sampling Method	All subjects who underwent non-cardiac surgery with pre- and postoperative cardiac troponin level were extracted using non-probability sampling. The information recorded at the time of admission to the patient, the perioperative cardiac troponin value, and the outcome of the time available for follow-up is collected by using anonymized data through a Samsung Medical Center clinical data warehouse (CDW).
Condition(s)/Problem(s)	Not Applicable-Etc All patients undergoing non-cardiac surgery at Samsung Medical Center are enrolled, so the condition or disease of the subject varies depending on the type of surgery.
Rare Disease	No
Inclusion Criteria	Gender Both
	Age No Limit~No Limit
	Description Patients who underwent non-cardiac surgery with pre- or postoperative troponin evaluation in Samsumg medical center from January 2010 to June 2019
Exclusion Criteria	None
Healthy Volunteers

10. Outcome Measure(s)

Outcome Measure(s) Information - Type of Primary Outcome, Primary Outcome, Outcome, Timepoint, Secondary Outcome, Outcome, Timepoint
Primary Outcome(s) 1
Type of Primary Outcome	clinical-equivalence
Outcome	Mortatlity
Timepoint	until 5 years after surgery
Secondary Outcome(s) 1
Outcome	Cardiovascular mortality
Timepoint	until 5 years after surgery
Secondary Outcome(s) 2
Outcome	Non-cardiovascular mortality
Timepoint	until 5 years after surgery
Secondary Outcome(s) 3
Outcome	major adverse cardiac and cerebrovascular event (MACCE)
Timepoint	until 5 years after surgery

11. Study Results and Publication

Study Results and Publication Information - Result Registered, Final Enrollment Number, Number of Publication, Publications, Results Upload, Date of Posting Results, Protocol URL or File Upload, Brief Summary
Result Registered	No

12. Sharing of Study Data(Deidentified Individual-Patient Data, IPD)

Sharing of Study Data Information - Sharing Statement, Time of Sharing, Way of Sharing
Sharing Statement	No

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