UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000042048 |
|---|---|
| Receipt number | R000047990 |
| Scientific Title | A prospective observational study of changes in coronary plaque and heart valve calcification after 2 years in patients with moderate coronary stenosis |
| Date of disclosure of the study information | 2020/10/10 |
| Last modified on | 2020/10/08 11:19:38 |
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Basic information
Public title
A prospective observational study of changes in coronary plaque and heart valve calcification after 2 years in patients with moderate coronary stenosis
Acronym
A prospective observational study of changes in coronary plaque and heart valve calcification after 2 years in patients with moderate coronary stenosis
Scientific Title
A prospective observational study of changes in coronary plaque and heart valve calcification after 2 years in patients with moderate coronary stenosis
Scientific Title:Acronym
A prospective observational study of changes in coronary plaque and heart valve calcification after 2 years in patients with moderate coronary stenosis
Region
| Japan |
Condition
Condition
Coronary atherosclerosis
Classification by specialty
| Cardiology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To observe patients with moderate or higher stenosis of the coronary arteries over time by coronary CT to investigate the progression and changes in plaque volume and properties and related factors.
We will also observe the association of coronary atherosclerosis with the progression of heart valve calcification over time and related factors.
Basic objectives2
Others
Basic objectives -Others
Observation of changes in lesions
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
(1)Factors related to changes in plaque in the coronary arteries during 2 years
(2)Factors related to the occurrence of cardiovascular events (cardiac death, non-fatal myocardial infarction, hospitalization due to unstable angina)
Key secondary outcomes
Factors associated with changes in heart valve calcification during 2 years
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
| 35 | years-old | <= |
Age-upper limit
| 75 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
(1)Continuous cases in which patients who can take coronary CT scan without a history of coronary artery disease, contrast medium allergy, or asthma.
(2)Patients who gave informed consent.
Key exclusion criteria
(1)Cases in which coronary CT images are poor and difficult to evaluate
(2)In addition, those who are judged to be inappropriate as research subjects by reserchers.
Target sample size
200
Research contact person
Name of lead principal investigator
| 1st name | Fujimoto |
| Middle name | |
| Last name | Shinichiro |
Organization
Juntendo University Graduate School of Medicine
Division name
Department of Cardiovascular Biology and Medicine
Zip code
113-8431
Address
3-1-3 Hongo, Bunkyo-ku, Tokyo
TEL
03-3813-3111
snfujimo@juntendo.ac.jp
Public contact
Name of contact person
| 1st name | Fujimoto |
| Middle name | |
| Last name | Shinichiro |
Organization
Juntendo University Graduate School of Medicine
Division name
Department of Cardiovascular Biology and Medicine
Zip code
113-8431
Address
3-1-3 Hongo, Bunkyo-ku, Tokyo
TEL
03-3813-3111
Homepage URL
snfujimo@juntendo.ac.jp
Sponsor or person
Institute
Juntendo University Graduate School of Medicine
Institute
Department
Personal name
Funding Source
Organization
No
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
Juntendo Clinical Research and Trial Center
Address
3-1-3 Hongo, Bunkyo-ku, Tokyo
Tel
03-3814-5672
kenkyu5858@juntendo.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
Other administrative information
Date of disclosure of the study information
| 2020 | Year | 10 | Month | 10 | 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
Open public recruiting
Date of protocol fixation
| 2020 | Year | 08 | Month | 28 | Day |
Date of IRB
| 2020 | Year | 08 | Month | 28 | Day |
Anticipated trial start date
| 2020 | Year | 10 | Month | 01 | Day |
Last follow-up date
| 2024 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
To observe patients with moderate or higher stenosis of the coronary arteries over time by coronary CT to investigate the progression and changes in plaque volume and properties and related factors.
We will also observe the association of coronary atherosclerosis with the progression of heart valve calcification over time and related factors.
Management information
Registered date
| 2020 | Year | 10 | Month | 08 | Day |
Last modified on
| 2020 | Year | 10 | Month | 08 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000047990
