UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000049687 |
|---|---|
| Receipt number | R000056592 |
| Scientific Title | Association between coronary artery calcification on non-gated chest computed tomography scans and myocardial injury after non-cardiac surgery |
| Date of disclosure of the study information | 2022/12/05 |
| Last modified on | 2022/12/08 09:02:36 |
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Basic information
Public title
Association between coronary artery calcification on non-gated chest computed tomography scans and myocardial injury after non-cardiac surgery
Acronym
coronary artery calcification and myocardial injury after non-cardiac surgery
Scientific Title
Association between coronary artery calcification on non-gated chest computed tomography scans and myocardial injury after non-cardiac surgery
Scientific Title:Acronym
coronary artery calcification and myocardial injury after non-cardiac surgery
Region
| Japan |
Condition
Condition
patient who receive lung resection for lung cancer
Classification by specialty
| Anesthesiology |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
To assess relationship between coronary artery calcification on non-gated chest computed tomography scans and myocardial injury after non-cardiac surgery
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Incidence of myocardial injury after non-cardiac surgery
Key secondary outcomes
morbidity, postoperative hospital stay, postoperative 30-day/1-year/2-year mortality
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
patient who receive lung resection for lung cancer
Key exclusion criteria
patient with preoperative high troponin I
patient with history of coronary artery bypass grafting
patient with history of percutaneous coronary intervention
Target sample size
160
Research contact person
Name of lead principal investigator
| 1st name | Koshiro |
| Middle name | |
| Last name | Kikkawa |
Organization
Ogaki Municipal Hospital
Division name
Department of anesthesiology
Zip code
503-8502
Address
4-86, Minaminokawacho, Ogaki, Gifu, Japan
TEL
0584-81-3341
kikkawa0330@gmail.com
Public contact
Name of contact person
| 1st name | Koshiro |
| Middle name | |
| Last name | Kikkawa |
Organization
Ogaki Municipal Hospital
Division name
Department of anesthesiology
Zip code
503-8502
Address
4-86, Minaminokawacho, Ogaki, Gifu, Japan
TEL
0584-81-3341
Homepage URL
kikkawa0330@gmail.com
Sponsor or person
Institute
Ogaki Municipal Hospital
Institute
Department
Personal name
Funding Source
Organization
Ogaki Municipal Hospital
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
Ogaki Municipal Hospital
Address
4-86, Minaminokawacho, Ogaki, Gifu, Japan
Tel
0584-81-3341
clinical-trial@omh.ogaki.gifu.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
Other administrative information
Date of disclosure of the study information
| 2022 | Year | 12 | Month | 05 | 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
Enrolling by invitation
Date of protocol fixation
| 2022 | Year | 11 | Month | 25 | Day |
Date of IRB
| 2022 | Year | 11 | Month | 25 | Day |
Anticipated trial start date
| 2022 | Year | 12 | Month | 06 | Day |
Last follow-up date
| 2026 | Year | 12 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Age, gender, height, body weight
past history, smoking history
complete blood count, AST,ALT, Bil, Cre. eGFR, BNP,troponin I, Alb, PT-INR, APTT,Fib
ECG,CT,Ultrasoundcardiography
intraoperative vital sign
ope time, anesthesia time, blood loss, infusion volume, blood transfusion, fluid balance
incidence of MINS, morbidity, hospital stay, postoperative 30day/1year/2year mortality
Management information
Registered date
| 2022 | Year | 12 | Month | 04 | Day |
Last modified on
| 2022 | Year | 12 | Month | 08 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000056592
