About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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.
Disqualifiers
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;
Trial design
Single group
Treatments tested in this trial
XTR004
DrugXTR004 as the experiemental drug, 99mTechnetium Sestamibi as the Active Comparator, and Coronary artery angiography as the refenrece standard
Treatment groups
Trial outcomes
Primary outcomes
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
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 outcomes
To evaluate the differences in diagnostic efficacy between XTR004 PET MPI and MIBI SPECT MPI in detecting restrictive stenosis
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
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
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
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
Sponsors and contacts
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