UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000050662 |
|---|---|
| Receipt number | R000057722 |
| Scientific Title | Impact of pericoronary adipose tissue attenuation on periprocedural myocardial injury in chronic coronary syndrome. |
| Date of disclosure of the study information | 2023/04/01 |
| Last modified on | 2024/09/22 09:06:16 |
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Basic information
Public title
Impact of pericoronary adipose tissue attenuation on periprocedural myocardial injury in chronic coronary syndrome.
Acronym
Impact of pericoronary adipose tissue attenuation on periprocedural myocardial injury in chronic coronary syndrome.
Scientific Title
Impact of pericoronary adipose tissue attenuation on periprocedural myocardial injury in chronic coronary syndrome.
Scientific Title:Acronym
Impact of pericoronary adipose tissue attenuation on periprocedural myocardial injury in chronic coronary syndrome.
Region
| Japan |
Condition
Condition
Chronic coronary syndrome
Classification by specialty
| Medicine in general | Cardiology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
the aim of this study was to investigate the clinical value of cCTA evaluation including PCAT attenuation associated with PMI among CCS patients.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
periprocedural myocardial injury
Key secondary outcomes
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
| 20 | years-old | <= |
Age-upper limit
| 100 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
1. patients with CCS who underwent PCI with drug-eluting stent implantation between Jan 2014 and Dec 2020; 2. patients who underwent cCTA to evaluate coronary plaque characteristics of the culprit lesion within 90 days before PCI; 3. patients who underwent serial measurements of high-sensitivity cardiac troponin I before PCI and within 48 h after PCI and 4. patients over 20 years old.
Key exclusion criteria
1. patients with a positive cTnI before PCI; 2. patients with coronary artery bypass grafted lesions; 3.patients with chronic total occlusion; 4. patients who were not implanted with DES; 5. patients with in-stent restenosis; 6. patients with severe calcified lesions; 7. patients with left main trunk lesion;8. patients with more than 2 lesions treated at the same procedure; 9. patients with side branch occlusion or flow limiting dissection during PCI procedure; 10. patients with cardiogenic shock during PCI; and 11. patients with insufficient CT data quality
Target sample size
125
Research contact person
Name of lead principal investigator
| 1st name | Tetsuya |
| Middle name | |
| Last name | Yamamoto |
Organization
Kobe university graduate school of medicine
Division name
Division of Cardiovascular Medicine, Department of Internal Medicine
Zip code
650
Address
7-5-1 Kusunoki-cho, Chuo-ku, Kobe, Hyogo
TEL
078-382-5846
ty07970928@gmail.com
Public contact
Name of contact person
| 1st name | Tetsuya |
| Middle name | |
| Last name | Yamamoto |
Organization
Kobe University Graduate School of Medicine
Division name
Division of Cardiovascular Medicine, Department of Internal Medicine
Zip code
6500017
Address
7-5-1 Kusunoki-cho, Chuo-ku, Kobe, Hyogo
TEL
078-382-5846
Homepage URL
ty07970928@gmail.com
Sponsor or person
Institute
Kobe University Graduate School of Medicine
Institute
Department
Personal name
Tetsuya Yamamoto
Funding Source
Organization
none
Organization
Division
Category of Funding Organization
Other
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
the Ethics Committee of Kobe University Hospital
Address
7-5-1 Kusunoki-cho, Chuo-ku, Kobe, Hyogo
Tel
078-382-5846
ty07970928@gmail.com
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
| 2023 | Year | 04 | Month | 01 | 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
Completed
Date of protocol fixation
| 2023 | Year | 04 | Month | 01 | Day |
Date of IRB
| 2023 | Year | 05 | Month | 24 | Day |
Anticipated trial start date
| 2023 | Year | 04 | Month | 01 | Day |
Last follow-up date
| 2023 | Year | 08 | Month | 31 | Day |
Date of closure to data entry
| 2023 | Year | 08 | Month | 31 | Day |
Date trial data considered complete
| 2023 | Year | 08 | Month | 31 | Day |
Date analysis concluded
| 2023 | Year | 08 | Month | 31 | Day |
Other
Other related information
none
Management information
Registered date
| 2023 | Year | 03 | Month | 23 | Day |
Last modified on
| 2024 | Year | 09 | Month | 22 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000057722
