UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000038410 |
|---|---|
| Receipt number | R000043770 |
| Scientific Title | Visualization of plaque inflammation by 18F-FDG PET/CT |
| Date of disclosure of the study information | 2019/10/29 |
| Last modified on | 2023/05/23 09:56:24 |
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Basic information
Public title
Visualization of plaque inflammation by 18F-FDG PET/CT
Acronym
Plaque study
Scientific Title
Visualization of plaque inflammation by 18F-FDG PET/CT
Scientific Title:Acronym
Plaque study
Region
| Japan |
Condition
Condition
Coronary artery disease
Classification by specialty
| Cardiology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The purpose of this study is to evaluate the presence of inflammatory plaque in acute coronary syndrome by evaluating the activity of coronary inflammatory plaque in each coronary artery disease group using 18F-FDG PET / CT.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Others
Developmental phase
Not applicable
Assessment
Primary outcomes
The primary outcome is to compare FDG accumulation (average value of the continuous amount of TBR) of plaque lesions by 18F-FDG PET / CT in patients with acute coronary syndrome, stable coronary artery disease group, and non-coronary artery disease group and to clarify the TBR value in patients with acute coronary syndrome.
Key secondary outcomes
1. Comparison of blood biomarkers (high-sensitivity CRP, endothelin 1, serotonin, MMP, interleukin 6, TBARS, etc.) between acute coronary syndrome group, stable coronary artery disease group, and non-coronary artery disease group.
2. Evaluation of correlation between the TBR (continuous dose) in coronary lesions and that in carotid lesions.
3. Evaluation of TBRs (continuous dose) before and after optical medical treatment in accordance with the guidelines for each group of acute coronary syndrome and stable coronary artery disease.
4. Examination of association between TBRs in coronary artery or carotid artery (before and after continuous dose and cutoff value) and prognosis.
5. Evaluation of predictors of TBR among variables (age, sex, diabetes history, hypertension history, dyslipidemia history, smoking history, myocardial infarction history, coronary revascularization history, blood LDL, HDL, high sensitivity CRP, troponin T and I, IL- 6, endothelin-1, MMP, serotonin, coronary stenosis, etc.).
6. Estimation of the cutoff value of TBR to distinguish acute coronary syndrome from stable coronary artery disease.
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
*Acute coronary syndrome
1. Patients who are over 20 years old at the time of obtaining consent
2. Patients diagnosed or suspected of ST-elevation myocardial infarction, non-ST-elevation myocardial infarction, or unstable angina
3. Patients who have received sufficient explanation for participation in this study, and who have fully understood and agreed to the document by their own free will.
* Stable coronary artery disease group
1. Patients who are over 20 years old at the time of obtaining consent
2. When coronary artery stenosis is recognized as moderate or higher by coronary angiography or coronary CT
3. Patients diagnosed with coronary artery disease from 2 above
4. Patients who have received sufficient explanation for participation in this study, and who have fully understood and agreed to the document by their own free will.
* Non-coronary artery disease group
1. Those who are 20 years of age or older when obtaining consent
2. Patients with suspected coronary artery disease who have no stenotic lesions on coronary CT or coronary catheterization
3. Parsons who have received sufficient explanation for participation in this study, and who have fully understood and agreed to the document by their own free will.
Key exclusion criteria
1. Patients who may become pregnant
2. Patients who cannot obtain written consent
3. For those with acute coronary syndrome, those who have judged that it is inappropriate to safely undergo 18F-FDG PET / CT (decompensated heart failure)
4. Diabetic patients receiving continuous subcutaneous insulin infusion therapy, or patients who are considered unable to fast for 18 hours.
5. Other persons who are deemed inappropriate by the research supervisor
Target sample size
120
Research contact person
Name of lead principal investigator
| 1st name | Masanao |
| Middle name | |
| Last name | Naya |
Organization
Hokkaido University Hospital
Division name
Cardiovascular Medicine
Zip code
060-8638
Address
North 15, West 7, Kita-ku, Sapporo
TEL
011-706-6973
nayamasanao@yahoo.co.jp
Public contact
Name of contact person
| 1st name | Masanao |
| Middle name | |
| Last name | Naya |
Organization
Hokkaido University Hospital
Division name
Cardiovascular Medicine
Zip code
060-8638
Address
North 15, West 7, Kita-ku, Sapporo
TEL
011-706-6973
Homepage URL
nayamasanao@yahoo.co.jp
Sponsor or person
Institute
Hokkaido University Hospital
Institute
Department
Personal name
Funding Source
Organization
Grants-in-Aid for Scientific Research, KAKENHI
Organization
Division
Category of Funding Organization
Japanese Governmental office
Nationality of Funding Organization
Japan
Other related organizations
Co-sponsor
Name of secondary funder(s)
Smoking Research Foundation
Mitsui Life Social Welfare Foundation
IRB Contact (For public release)
Organization
Hokkaido University Hospital
Address
North 15, West 7, Kita-ku, Sapporo
Tel
011-706-7636
crjimu@huhp.hokudai.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
北海道大学病院 (北海道)
市立札幌病院 (北海道)
NTT東日本札幌病院 (北海道)
医療法人サンプラザ 新札幌循環器病院 (北海道)
北海道大野記念病院 (北海道)
斗南病院 (北海道)
Other administrative information
Date of disclosure of the study information
| 2019 | Year | 10 | Month | 29 | 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
No longer recruiting
Date of protocol fixation
| 2019 | Year | 10 | Month | 23 | Day |
Date of IRB
| 2019 | Year | 10 | Month | 23 | Day |
Anticipated trial start date
| 2019 | Year | 10 | Month | 29 | Day |
Last follow-up date
| 2023 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Prospective observational study with invasion
Case registration period: Date of IRB - 2021/3/31
Research registration period: Date of IRB - 2025/3/31
Management information
Registered date
| 2019 | Year | 10 | Month | 28 | Day |
Last modified on
| 2023 | Year | 05 | Month | 23 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000043770
