Visualization of plaque inflammation by 18F-FDG PET/CT

UMIN ID: UMIN000038410

Registered date:29/10/2019

Basic Information

• Recruitment status: Complete: follow-up continuing
• Health condition(s) or Problem(s) studied: Coronary artery disease
• Date of first enrollment: 2019/10/29
• Target sample size: 120
• Countries of recruitment: Japan
• Study type: Observational

Outcome(s)

• Primary Outcome: 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.
• Secondary Outcome: 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.

Key inclusion & exclusion criteria

• Age minimum: 20years-old
• Age maximum: Not applicable
• Gender: Male and Female
• Exclude 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

Related Information

• Primary Sponsor: Hokkaido University Hospital
• Source(s) of Monetary Support: Grants-in-Aid for Scientific Research, KAKENHI,Smoking Research Foundation Mitsui Life Social Welfare Foundation