Status Approved
First Submitted Date
2019/10/12
Registered Date
2019/10/17
Last Updated Date
2019/10/12
CRIS Required
WHO ICTRP (International Clinical Trial Registry Platform) Required
1. Background
CRIS Registration Number |
KCT0004348 |
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Unique Protocol ID | SMC 2019-07048 |
Public/Brief Title | perioperative troponin change and postoperative outcome |
Scientific Title | Evaluation of the relationship between pre- and postoperative myocardial injury in non-cardiac surgery and 30-day mortality based on the 4th universal definition of myocardial infarction. |
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
Board Approval Status | Submitted approval |
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Board Approval Number | SMC 2018-12-002-002 |
Approval Date | 2019-09-24 |
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 Person for Principal Investigator / Scientific Queries | |
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Name | Jong-Hwan Lee |
Title | Associate Professor |
Telephone | +82-2-3410-0361 |
Affiliation | Samsung Medical Center |
Address | Samsung Medical Center, Sungkyunkwan University School of Medicine, 81 Irwon-ro, Gangnam-gu, Seoul 06351, Korea |
Contact Person for Public Queries | |
Name | Jungchan Park |
Title | Assistant professor |
Telephone | +82-2-3410-7682 |
Affiliation | Samsung Medical Center |
Address | Samsung Medical Center, Sungkyunkwan University School of Medicine, 81 Irwon-ro, Gangnam-gu, Seoul 06351, Korea |
Contact Person for Updating Information | |
Name | Seung-Hwa Lee |
Title | Assistant professor |
Telephone | +82-2-3410-5687 |
Affiliation | Samsung Medical Center |
Address | Samsung Medical Center, Sungkyunkwan University School of Medicine, 81 Irwon-ro, Gangnam-gu, Seoul 06351, Korea |
4. Status
Study Site | Single | |
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Overall Recruitment Status | Recruiting | |
Date of First Enrollment | 2019-09-25 Actual | |
Target Number of Participant | 5000 | |
Primary Completion Date | ||
Study Completion Date | ||
Recruitment Status by Participating Study Site 1 | ||
Name of Study | Samsung Medical Center | |
Recruitment Status | Recruiting | |
Date of First Enrollment | 2019-09-25 , |
5. Source of Monetary / Material Support
1. Source of Monetary/Material Support | |
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Organization Name | Samsung Medical Center |
Organization Type | Medical Institute |
Project ID |
6. Sponsor Organization
1. Sponsor Organization | |
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Organization Name | Samsung Medical Center |
Organization Type | Medical Institute |
7. Study Summary
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. So we aimed to evaluate whether this change is associated with postoperative outcomes. |
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8. Study Design
Study Type | Observational Study |
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Observational Study Model | Cohort |
Time Perspective | Retrospective |
Target Number of Participant | 5000 |
Cohort/Group Number | 1 |
Cohort/ Group 1 |
Cohort/Group Label Patients who underwent non-cardiac surgery |
Cohort/Group Description Patients who underwent non-cardiac surgery with pre- and postoperative cardiac troponin in Samsumg medical center from January 2010 to June 2018 to evaluate clinical outcomes according to perioperative cardiac troponin levels |
|
Biospecimen Collection & Archiving |
Not collect nor Archive |
Biospecimen Description |
9. Subject Eligibility
Study Population Description | Patients who are undergoing non-cardiac surgery in Samsung medical center |
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Sampling Method | All subjects who underwent non-cardiac surgery with pre- and postoperative cardiac troponin level were extracted in the aid of medical information department. |
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 18Year~No Limit |
|
Description Patients who underwent non-cardiac surgery with pre- and postoperative troponin evaluation in Samsumg medical center from January 2010 to June 2018 |
|
Exclusion Criteria |
none |
Healthy Volunteers |
10. Outcome Measure(s)
Type of Primary Outcome | clinical-equivalence | |
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Primary Outcome(s) 1 | ||
Outcome | mortality |
|
Timepoint | 30-day follow-up |
|
Secondary Outcome(s) 1 | ||
Outcome | mortality |
|
Timepoint | overall follow-up |
11. Study Results and Publication
Result Registered | No |
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12. Sharing of Study Data(Deidentified Individual-Patient Data, IPD)
Sharing Statement | No |
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