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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| enrolled participants with suspected or known CAD | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| XTR004 | Drug | XTR004 as the experiemental drug, 99mTechnetium Sestamibi as the Active Comparator, and Coronary artery angiography as the refenrece standard |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 | 60 days |
| Measure | Description | Time Frame |
|---|---|---|
| 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 | 60 days |
| To assess differences in image quality and diagnostic certainty between XTR004 PET MPI and MIBI SPECT MPI |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| LING YUAN | Contact | 010-80716990 | ling.yuan@sinotau.com |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Beijing Anzhen Hospital, Capital Medical University | Recruiting | Beijing | China | |||
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|
Overall summary of image quality and diagnostic certainty of XTR004 PET MPI and MIBI SPECT MPI |
| 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 | 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 | 60 days |
| To compare the differences in diagnostic performance between XTR004 PET MPI and MIBI SPECT MPI using QCA results as a reference standard | Overall summary of diagnostic efficacy of XTR004 PET MPI and MIBI SPECT MPI using QCA results as a reference standard | 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 | 60 days |
| Beijing Tongren Hospital |
| Recruiting |
| Beijing |
| China |
| Peking Union Medical College Hospital | Recruiting | Beijing | China |
| The First People's Hospital of Foshan | Recruiting | Foshan | China |
| TEDA International Cardiovascular Hospital | Recruiting | Tianjin | China |
| ID | Term |
|---|---|
| D003324 | Coronary Artery Disease |
| ID | Term |
|---|---|
| D003327 | Coronary Disease |
| D017202 | Myocardial Ischemia |
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
| D001161 | Arteriosclerosis |
| D001157 | Arterial Occlusive Diseases |
| D014652 | Vascular Diseases |
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