Evaluation of XTR004 as a Novel 18F-labeled PET MPI Tracer in Diagnosis of Known or Suspected CAD

Exclusion Criteria

• •1. Severe cardiovascular disease, including but not limited to an acute coronary syndrome, second or third-degree atrioventricular, sinoatrial block, NYHA class iii and iv, heart failure, dilated or hypertrophic cardiomyopathy, etc., and have been assessed by the investigator as unsuitable to participate in this study.
• •2. Severe acute or chronic lung disease, including but not limited to chronic obstructive pulmonary disease, asthma, bronchiectasis, emphysema, pulmonary fibrosis, pulmonary embolism, pneumonia, etc., and have been assessed by the investigator as unsuitable to participate in this study.
• •3. Severe or unstable central nervous system disease, including but not limited to unstable cerebrovascular disease, active epilepsy, infectious disease of the central nervous system, etc., and have been assessed by the investigator as unsuitable to participate in this study.
• •4. Severe bleeding disorders or coagulation disorders, including but not limited to purpura, hemophilia, vitamin K deficiency, etc., and have been assessed by the investigator as unsuitable to participate in this study.
• •5. Severe liver disease, including but not limited to viral hepatitis, autoimmune hepatitis, liver cirrhosis, liver cancer, etc., and have been assessed by the investigator as unsuitable to participate in this study.
• •6. Severe renal impairment, including but not limited to glomerular nephropathy, hydronephrosis, renal cysts, etc., and have been assessed by the investigator as unsuitable to participate in this study.
• •7. Patients with febrile or active infectious disease, and have been assessed by the investigator as unsuitable to participate in this study.
• •8. Patients with serious disease of other organ systems other than those not mentioned above and have been assessed by the investigator as unsuitable to participate in this study.
• •9. Known to be allergic to adenosine.
• •10. Severe allergic reaction to alcohol.
• •11. Known to be allergic to iodine contrast tracers.
• •12. Significant occupational exposure to or treatment with ionizing radiation (e.g., more than 50 mSv/yr) within 10 years.
• •13. Pregnancy or lactating woman.
• •14. Patients with mental disorders or poor compliance.
• •15. Those who have participated in another clinical study 30 days before enrollment or during follow-up.
• •16. Men and women of reproductive age refused to adopt contraceptive plans during the study period and 6 months after the study ended.
• •17. Other circumstances that the investigator considers inappropriate for participating in the study.