UMIN-ICDS Clinical Trial
| Unique ID issued by UMIN | UMIN000052714 |
|---|---|
| Receipt number | R000058423 |
| Scientific Title | Risk Assessment of Coronary Artery Disease by CT Values of Peri-Achilles Tendon Tissue |
| Date of disclosure of the study information | 2023/11/13 |
| Last modified on | 2023/11/07 12:25:07 |
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Basic information
Public title
Risk Assessment of Coronary Artery Disease by CT Values of Peri-Achilles Tendon Tissue
Acronym
Risk Assessment of Coronary Artery Disease by CT Values of Peri-Achilles Tendon Tissue
Scientific Title
Risk Assessment of Coronary Artery Disease by CT Values of Peri-Achilles Tendon Tissue
Scientific Title:Acronym
Risk Assessment of Coronary Artery Disease by CT Values of Peri-Achilles Tendon Tissue
Region
| Japan |
Condition
Condition
angina pectoris
Classification by specialty
| Cardiology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Patients undergoing coronary CT will be included in the study to measure CT values of adipose tissue around the Achilles tendon. To evaluate the complication rate of coronary artery disease in CT values of peri-Achilles tendon tissue.
Basic objectives2
Others
Basic objectives -Others
The association with LDL cholesterol levels, CRP and perivascular fat attenuation index will also be evaluated.
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Presence of coronary artery disease and CT values of peri-Achilles tendon tissue
Key secondary outcomes
TG, HDL, LDL cholesterol, CRP, short diameter of Achilles tendon, association between CT value of peri-coronary fat and CT value of Achilles tendon fat, ABI , CAVI
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
| Not applicable |
Gender
Male and Female
Key inclusion criteria
1) Patients who have no history of coronary artery disease and are undergoing their first coronary CT scan.
2) Patients who are at least 20 years of age.
3) Patients who can give their consent to participate in this study.
Key exclusion criteria
1) Patients with a history of coronary artery treatment (PCI, CABG)
2) Patients with contraindications to contrast media
3) Patients under 20 years of age
4) Patients with a prognosis of less than 1 year due to malignancy, etc.
Target sample size
1200
Research contact person
Name of lead principal investigator
| 1st name | Naoaki |
| Middle name | |
| Last name | Matsuo |
Organization
Okayama City General Medical Center Okayama city Hospital
Division name
Cardiology
Zip code
700-8557
Address
3-20-1, Kitanagase, Kita-ku, Okayama City, Okayama
TEL
086-737-3000
monkey1matsuo@gmail.com
Public contact
Name of contact person
| 1st name | Naoaki |
| Middle name | |
| Last name | Matsuo |
Organization
Okayama City General Medical Center Okayama city Hospital
Division name
Cardiology
Zip code
700-8557
Address
3-20-1, Kitanagase, Kita-ku, Okayama City, Okayama
TEL
086-737-3000
Homepage URL
monkey1matsuo@gmail.com
Sponsor or person
Institute
Okayama City General Medical Center Okayama city Hospital
Institute
Department
Personal name
Funding Source
Organization
None
Organization
Division
Category of Funding Organization
Other
Nationality of Funding Organization
Other related organizations
Co-sponsor
Minamino Junkanki Hospital
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Okayama City Hospital Clinical Ethics Committee
Address
3-20-1, Kitanagase, Kita-ku, Okayama City, Okayama
Tel
087-737-3000
monkey1matsuo@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 | 11 | Month | 13 | 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 | 10 | Month | 01 | Day |
Date of IRB
Anticipated trial start date
| 2023 | Year | 11 | Month | 01 | Day |
Last follow-up date
| 2025 | Year | 12 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
observational study
Management information
Registered date
| 2023 | Year | 11 | Month | 07 | Day |
Last modified on
| 2023 | Year | 11 | Month | 07 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000058423
| 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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