UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000048206 |
|---|---|
| Receipt number | R000054624 |
| Scientific Title | Postoperative complications in high-risk patients for myocardial injury after noncardiac surgery in Japan: A retrospective, observational study |
| Date of disclosure of the study information | 2022/06/30 |
| Last modified on | 2023/06/21 13:50:56 |
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Basic information
Public title
Postoperative complications in high-risk patients for myocardial injury after noncardiac surgery in Japan: A retrospective, observational study
Acronym
Postoperative complications in high-risk patients for myocardial injury after noncardiac surgery in Japan: A retrospective, observational study
Scientific Title
Postoperative complications in high-risk patients for myocardial injury after noncardiac surgery in Japan: A retrospective, observational study
Scientific Title:Acronym
Postoperative complications in high-risk patients for myocardial injury after noncardiac surgery in Japan: A retrospective, observational study
Region
| Japan |
Condition
Condition
Myocardial injury after non cardiac surgery
Classification by specialty
| Cardiology | Surgery in general | Anesthesiology |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
To investigate prevalence and features of postoperative complications in high-risk patients for myocardial injury after noncardiac surgery, and to explore perioperative factors for cardial injury after noncardiac surgery.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
major postoperative complications within 30 days after surgery,
Key secondary outcomes
incidence of Myocardial Injury after Non-cardiac Surgery, changes in troponin before and after surgery, and to explore perioperative factors for cardial injury after noncardiac surgery.
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
| 45 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
Patients undergoing major thoracic or abdominal surgery under general anesthesia who have at least more than 3 risk factors for Myocardial Injury after Non-cardiac Surgery such as older than 75 years, male, atrial fibrillation, diabetes, hypertension, cardiac failure (history), coronary artery disease, peripheral vascular disease, renal dysfunction (eGFR<60), and stroke.
Key exclusion criteria
1. emergency surgery
2. reoperation within the same hospitarlization
3. Troponin T data loss that makes MINS diagnosis difficult
Target sample size
300
Research contact person
Name of lead principal investigator
| 1st name | YOSHIHIRO |
| Middle name | |
| Last name | YAMAJI |
Organization
Graduate School of Medicine, Chiba University
Division name
Department of Anesthesiology
Zip code
260-8670
Address
1-8-1 Inohana, Chuo-ku, Chiba city, Chiba, Japan
TEL
043-222-7171
yamayoshi1228@yahoo.co.jp
Public contact
Name of contact person
| 1st name | YOSHIHIRO |
| Middle name | |
| Last name | YAMAJI |
Organization
Graduate School of Medicine, Chiba University
Division name
Department of Anesthesiology
Zip code
260-8670
Address
1-8-1 Inohana, Chuo-ku, Chiba city, Chiba, Japan
TEL
0432227171
Homepage URL
yamayoshi1228@yahoo.co.jp
Sponsor or person
Institute
Others
Institute
Department
Personal name
Funding Source
Organization
Others
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
Graduate School of Medicine, Chiba University
Address
1-8-1 Inohana, Chuo-ku, Chiba city, Chiba, Japan
Tel
0432227171
yamayoshi1228@yahoo.co.jp
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
千葉大学医学部附属病院（千葉県）
Other administrative information
Date of disclosure of the study information
| 2022 | Year | 06 | Month | 30 | 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
No longer recruiting
Date of protocol fixation
| 2022 | Year | 01 | Month | 07 | Day |
Date of IRB
| 2022 | Year | 01 | Month | 07 | Day |
Anticipated trial start date
| 2022 | Year | 06 | Month | 20 | Day |
Last follow-up date
| 2023 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
A retrospective medical record survey on MINS will be conducted at the tertiary hospital in Japan. Investigate MINS incidence, postoperative complications, and perioperative associated factors of MINS in high-risk patients for MINS.
Management information
Registered date
| 2022 | Year | 06 | Month | 30 | Day |
Last modified on
| 2023 | Year | 06 | Month | 21 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000054624
| Research Plan | |
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| Registered date | File name |
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| Registered date | File name |
| Research case data | |
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