UMIN-ICDS Clinical Trial
| Unique ID issued by UMIN | UMIN000053416 |
|---|---|
| Receipt number | R000060963 |
| Scientific Title | surveillance of perioperative myocardial injury (PMI) after noncardiac surgery |
| Date of disclosure of the study information | 2024/01/25 |
| Last modified on | 2024/01/29 12:16:03 |
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Basic information
Public title
surveillance of perioperative myocardial injury (PMI) after noncardiac surgery
Acronym
surveillance of perioperative myocardial injury (PMI) after noncardiac surgery
Scientific Title
surveillance of perioperative myocardial injury (PMI) after noncardiac surgery
Scientific Title:Acronym
surveillance of perioperative myocardial injury (PMI) after noncardiac surgery
Region
| Japan |
Condition
Condition
Non-cardiac surgery patients
Classification by specialty
| Cardiology | Anesthesiology |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
This study investigates the incidence of perioperative myocardial injury (PMI) in adult patients undergoing non-cardiac surgery in Japan.
Basic objectives2
Others
Basic objectives -Others
This study investigates the incidence of PMI and 30-day major adverse cardiovascular events, as well as their patient background and surgical risk.
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Incidence of perioperative myocardial injury (PMI) after non-cardiac surgery
Key secondary outcomes
Incidence of 30-day major adverse cardiovascular events and patient's and surgical risk
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
| 18 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
Patients more than 18 years old undergoing noncardiac surgery.
Key exclusion criteria
(1) Patients who do not have blood test before surgery
(2) Patients undergoing day surgery
(3) Other patients who are judged by the researcher to be inappropriate as research subjects
Target sample size
2000
Research contact person
Name of lead principal investigator
| 1st name | Ken |
| Middle name | |
| Last name | Yamaura |
Organization
Kyushu University
Division name
Department of Anesthesiology and Critical Care Medicine, Graduate school of Medical Sciences
Zip code
812-8582
Address
3-1-1 Maidashi, Higashi-ku, Fukuoka 812-8582 JAPAN
TEL
092-642-5714
yamaura.ken.361@m.kyushu-u.ac.jp
Public contact
Name of contact person
| 1st name | Midoriko |
| Middle name | |
| Last name | Higashi |
Organization
Kyushu University
Division name
Department of Anesthesiology and Critical Care Medicine, Graduate school of Medical Sciences
Zip code
812-8582
Address
3-1-1 Maidashi, Higashi-ku, Fukuoka 812-8582 JAPAN
TEL
092-62-5714
Homepage URL
higashi.midoriko.976@m.kyushu-u.ac.jp
Sponsor or person
Institute
Kyushu University
Institute
Department
Personal name
Funding Source
Organization
Other
Organization
Division
Category of Funding Organization
Profit organization
Nationality of Funding Organization
Other related organizations
Co-sponsor
Hokkaido University
Chiba University
Juntendo University Nerima Hospital
Chiba Kaihin Municipal Hospital
Tokyo Wemen's Medical University
Nagoya City University Midori Municipal Hospital
Keio University
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Kyushu University Medical District Observation Research Ethics Review Committee
Address
3-1-1 Maidashi, Higashi-ku, Fukuoka 812-8582 JAPAN
Tel
092-642-6254
ijkrinri@jimu.kyushu-u.ac.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
九州大学病院（福岡県）
千葉大学医学部附属病院（千葉県）
東京女子医科大学病院（東京都）
順天堂大学医学府付属練馬病院（東京都）
名古屋市立大学医学部附属みどり市民病院（愛知県）
千葉市立海浜病院（千葉県）
Other administrative information
Date of disclosure of the study information
| 2024 | Year | 01 | Month | 25 | 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
Preinitiation
Date of protocol fixation
| 2023 | Year | 12 | Month | 22 | Day |
Date of IRB
| 2023 | Year | 12 | Month | 22 | Day |
Anticipated trial start date
| 2024 | Year | 02 | Month | 01 | Day |
Last follow-up date
| 2025 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
(1) Patients who have obtained consent will be registered as research subjects, and the following information will be obtained from medical records.
Age, gender, height, weight, current medical history, medical history, regular oral medication
Blood pressure, pulse rate, body temperature, respiratory rate, SpO2
Blood test results: WBC, Hb, HT, PLT
Blood test results: TP, Alb, AST, ALT, BUN, Cr, T-Chol, LDL-Chol, HDL-Chol, TG, BS, HbA1c, CK, BNP, NT-proBNP
Chest X-ray, physiological laboratory findings (electrocardiogram, echocardiographic findings)
Surgical type, operative time, intraoperative events (complications)
Anesthesia technique, anesthesia time, amount of bleeding, amount of infusion / blood transfusion, urine output
Events 30 days postoperatively (complications)
(2) 1 ml of residual blood collected at the time of normal medical examination (before surgery and up to 2 times after the first day after surgery) as a sample. If blood collection before and after surgery is not performed in normal medical care, 5 ml of blood is collected before surgery and after the first day after surgery. If blood is drawn for research, 5 ml X 2 blood for a maximum total of 10 ml.
(3) Process personal information by linking and anonymizing samples, medical information, personal information, etc.
(4) Samples (blood) processed with personal information at each joint research institute will be sent to Roche Diagnostics Co., Ltd. (Japan) by traceable mail or other means to measure high-sensitivity troponin T. (However, if high-sensitivity troponin T can be measured at your own facility, it is possible to use the measurement results.)
(5) Patient information whose personal information has been processed by each joint research institute will be registered on the web in the EDC system established by the Department of Cardiovascular Medicine, Hokkaido University Graduate School of Medicine, and collected.
Management information
Registered date
| 2024 | Year | 01 | Month | 23 | Day |
Last modified on
| 2024 | Year | 01 | Month | 29 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000060963
| 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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