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.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
DIAGNOSTIC
Masking
NONE
Enrollment
395
XTR004 as the experiemental drug, 99mTechnetium Sestamibi as the Active Comparator, and Coronary artery angiography as the refenrece standard
Beijing Anzhen Hospital, Capital Medical University
Beijing, China
RECRUITINGBeijing Tongren Hospital
Beijing, China
RECRUITINGPeking Union Medical College Hospital
Beijing, China
RECRUITINGDiagnostic 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
Time frame: 60 days
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
Time frame: 60 days
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
Time frame: 60 days
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
Time frame: 60 days
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
Time frame: 60 days
To compare the differences in diagnostic performance between XTR004 PET MPI and MIBI SPECT MPI using QCA results as a reference standard
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The First People's Hospital of Foshan
Foshan, China
RECRUITINGTEDA International Cardiovascular Hospital
Tianjin, China
RECRUITINGOverall summary of diagnostic efficacy of XTR004 PET MPI and MIBI SPECT MPI using QCA results as a reference standard
Time frame: 60 days
Number of participants with treatment-related adverse events, severe adverse events as assessed by CTCAE v5.0
To assess the safety in subjects with suspected or confirmed stable coronary artery disease after two consecutive intravenous bolus injections of XTR004 solution
Time frame: 60 days