Coronary Artery Disease(CAD)
Conditions
Brief summary
The primary objective of this study is to evaluate the effectiveness of visual reading in XTR004 PET myocardial perfusion imaging (MPI) for detecting restrictive stenosis, using quantitative coronary angiography (QCA) and fractional flow reserve (FFR) as reference standards in patients with suspected or known coronary artery disease.
Interventions
DRUGXTR004
XTR004 as the experiemental drug, 99mTechnetium Sestamibi as the Active Comparator, and Coronary artery angiography as the refenrece standard
Sponsors
Sinotau Pharmaceutical Group
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
DIAGNOSTIC
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 80 Years
Healthy volunteers
No
Inclusion criteria
* Participants aged 18 to 80 years, male or female. * 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. * 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
* 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; * 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; * 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; * 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; * 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; * 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; * Participants with fever or active infectious diseases who are determined unsuitable for participation by the investigator; * Participants with known alcohol allergy who are determined unsuitable for participation by the investigator; * participants with known adenosine allergy who are determined unsuitable for participation by the investigator; * Participants with known iodine contrast agent allergy who are determined unsuitable for participation by the investigator; * 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; * 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); * Female participants in pregnancy or lactation * Individuals with claustrophobia, bipolar disorder, mental disorders, or poor compliance; * Participation in other investigational drug trials within 30 days prior to enrollment or planned during study; * Any other circumstances determined unsuitable by investigators.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Diagnostic Efficacy of XTR004 PET myocardial perfusion imaging (MPI) for detecting restrictive stenosis, using quantitative coronary angiography (QCA) and fractional flow reserve (FFR) as reference standards | 60 days | Sensitivity and specificity of XTR004 PET myocardial perfusion imaging (MPI) for detecting restrictive stenosis, using quantitative coronary angiography (QCA) and fractional flow reserve (FFR) as reference standards |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| To evaluate the differences in diagnostic efficacy between XTR004 PET MPI and MIBI SPECT MPI in detecting restrictive stenosis | 60 days | Sensitivity and specificity of XTR004 PET MPI and MIBI SPECT MPI in detecting restrictive stenosis |
| To assess differences in image quality and diagnostic certainty between XTR004 PET MPI and MIBI SPECT MPI | 60 days | Overall summary of image quality and diagnostic certainty of XTR004 PET MPI and MIBI SPECT MPI |
| To validate the effectiveness of semi-quantitative analysis in XTR004 PET MPI for the detection of restrictive stenosis | 60 days | Overall summary of the sensitivity and specificity of semi-quantitative analysis in XTR004 PET MPI for the detection of restrictive stenosis |
| To evaluate the diagnostic efficacy of XTR004 PET MPI in different subgroups | 60 days | Sensitivity and specificcity of XTR004 PET MPI in detection of flow-limiting stenosis in different subgroups, including subjects with different stenosis degrees detected by CTA, female, BMI ≥30kg/m2, and subjects with diabetes |
| To compare the differences in diagnostic performance between XTR004 PET MPI and MIBI SPECT MPI using QCA results as a reference standard | 60 days | Overall summary of diagnostic efficacy of XTR004 PET MPI and MIBI SPECT MPI using QCA results as a reference standard |
| Number of participants with treatment-related adverse events, severe adverse events as assessed by CTCAE v5.0 | 60 days | To assess the safety in subjects with suspected or confirmed stable coronary artery disease after two consecutive intravenous bolus injections of XTR004 solution |
Countries
China
Contacts
CONTACTLING YUAN
Outcome results
None listed