Suspected or known stable coronary heart disease
Conditions
Interventions
Experimental group:There is no strict requirement for the order of MIBI SPECT MPI (rest and stress) and XTROD4 PET MPI (rest and stress)
it is acceptable if the two are not performed on the same day.
Sponsors
Peking Union Medical College Hospital, Chinese Academy of Medical Sciences
Eligibility
Sex/Gender
All
Age
18 Years to 80 Years
Inclusion criteria
Inclusion criteria: 1. Participants aged 18 to 80 years, male or female. 2. Suspected or confirmed patients with stable coronary heart disease. Those suspected of having stable coronary heart disease must meet at least one of the following risk factors: hypertension, hyperlipidemia, diabetes, obesity (BMI >=28), a history of alcohol abuse, a smoking history, a family history of coronary heart disease, postmenopausal status, or age 60 years or older. 3. Participants can communicate well with investigators, understand and comply with clinical trial requirements, voluntarily participate in the study, and sign an informed consent form.
Exclusion criteria
Exclusion criteria: 1. Participants with severe cardiovascular diseases, including but not limited to unstable angina (Canadian Cardiac Society (CCS) Grade III/IV angina pectoris), uncontrolled hypertension (systolic blood pressure >= 180 mmHg and/or diastolic =110 mmHg despite long-term regular antihypertensive medication), hypotension (resting systolic blood pressure <90 mmHg), acute myocardial infarction, second or third-degree atrioventricular block, sinoatrial node disease, NYHA Class III/IV heart failure, dilated or hypertrophic cardiomyopathy, pericarditis, valvular heart disease, aortic dissection, uncontrolled severe arrhythmias, congenital heart disease, those who have undergone coronary artery bypass grafting or interventional procedures within three months, and those determined unsuitable for participation in this study by investigators; 2. Participants with severe acute or chronic pulmonary diseases (including but not limited to COPD, asthma, bronchiectasis, emphysema, pulmonary fibrosis, pulmonary embolism, pneumonia, etc.) who are determined unsuitable for participation by the investigator; 3. Participants with severe or unstable central nervous system disorders (including but not limited to unstable cerebrovascular diseases, active epilepsy, CNS infections, CNS diseases accompanied by mental disorders or motor impairments) who are determined unsuitable for participation by the investigator; 4. Participants with severe bleeding disorders or coagulation dysfunction (including but not limited to purpura, hemophilia, vitamin K deficiency, etc.) who are determined unsuitable for participation by the investigator; 5. Participants with severe liver dysfunction (including but not limited to viral hepatitis, autoimmune hepatitis, cirrhosis, liver cancer, etc.) who are determined unsuitable for participation by the investigator; 6. Participants with severe kidney impairment (including but not limited to glomerulonephritis, renal insufficiency, nephrotic syndrome, membranous nephropathy, hydronephrosis, renal cystopathy, etc.) who are determined unsuitable for participation by the investigator; 7. Participants with fever or active infectious diseases who are determined unsuitable for participation by the investigator; 8. Participants with known alcohol allergy who are determined unsuitable for participation by the investigator; 9. Participants with known adenosine allergy who are determined unsuitable for participation by the investigator; 10. Participants with known iodine contrast agent allergy who are determined unsuitable for participation by the investigator; 11. Within the past 10 years, significant occupational exposure to ionizing radiation (e.g., exceeding 50 mSv/year) or exposure to radioactive substances or ionizing radiation for therapeutic/research purposes; 12. Male or women of childbearing age not using effective contraception during study participation and within 6 months post-study (effective contraception refers to sterilization, intrauterine device, condoms, abstinence, or surgical blockage of vas deferens/fallopian tubes); 13. Female participants in pregnancy or lactation; 14. Individuals with claustrophobia, bipolar disorder, mental disorders, or poor compliance; 15. Participation in other investigational drug trials within 30 days prior to enrollment or planned during study; 16. Any other circumstances determined unsuitable by investigators.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Imaging of XTR004 PET MPI;QCA (Quantitative Coronary Angiography) for detecting coronary artery stenosis severity; | — |
Secondary
| Measure | Time frame |
|---|---|
| Physical examination indicators;Adverse events and serious adverse events;The specificity of XTR004 PET MPI visual reading in detection of blood flow restrictive stenosis;The sensitivity of XTR004 PET MPI visual reading in detection of blood flow restrictive stenosis;Vital signs;Laboratory tests indicators;Fractional Flow Reserve (FFR);Electrocardiogram indicators;Imaging of MIBI SPECT MPI; | — |
Countries
China
Contacts
Public ContactZhang Shuyang, Li Huo
Peking Union Medical College Hospital, Chinese Academy of Medical Sciences
Outcome results
None listed