The diagnostic efficacy and safety of the XTR004 myocardial perfusion PET imaging tracer are evaluated for known or suspected CAD with the use of invasive coronary angiography as the reference standard for the diagnosis of CAD and invasive pressure-temperature FFR/IMR as a reference for the detection of abnormal coronary function.
A phase II study that is single-arm, open-label, multi-center, and self-controlled with the following objectives; 1. Quantitative diagnostic efficacy of XTR004 perfusion imaging tracer in the diagnosis of known or suspected CAD using invasive coronary angiography as a reference standard for CAD. 2. The effectiveness of XTR004 myocardial perfusion imaging tracer in the detection of CAD using a pressure-temperature guide wire fractional flow reserve (FFR), and index of microcirculation resistance (IMR) as a reference standard to confirm abnormal coronary blood flow reserve and microvascular disfunction. 3. Subjects' safety after two doses of XTR004 intravenous injection.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
DIAGNOSTIC
Masking
NONE
Enrollment
83
At rest: IV bolus injection of XTR004 with a dose range of 2.0-2.5 mCi At stress: IV infusion of adenosine at a rate of 140 μg/kg/min. IV bolus injection of XTR004 with a dose range of 6.0-7.5 mCi.
Beijing Hospital
Beijing, Beijing Municipality, China
Beijing Tongren Hospital
Beijing, Beijing Municipality, China
Qualitative reading and semi-qualitative MPI analysis (SSS and SDS)
Sensitivity and specificity of XTR004 PET MPI for the detection of ≥50% and ≥70% threshold coronary stenosis. Sensitivity and specificity of XTR004 PET MPI for the detection of abnormal function of epicardial coronary (FFR\<0.8, IMR\<25), abnormal coronary microcirculation (FFR≥0.8, IMR≥25), abnormal of both (FFR\<0.8, IMR≥25), and their corresponding thresholds.
Time frame: Day 1
Quantitative index of XTR004 PET myocardial blood flow (Stress MBF, MFR)
Sensitivity and specificity of XTR004 PET myocardial blood flow quantitative index (stress MBF, MFR) for the detection of ≥50% and ≥70% threshold coronary stenosis. Sensitivity and specificity of XTR004 PET MPI for the detection of abnormal function of epicardial coronary (FFR\<0.8, IMR\<25), abnormal coronary microcirculation (FFR≥0.8, IMR≥25), abnormal of both (FFR\<0.8, IMR≥25), and their corresponding thresholds.
Time frame: Day 1
Number of study participants with treatment-related adverse events as determined by safety parameter changes according to CTCAE v5.0
Safety parameters included adverse events, vital signs (body temperature, blood pressure, respiration rate, pulse rate), physical examinations, laboratory tests (serum cardiac biomarkers, cardiac troponin I, serum biochemistry, haematology, and urinalysis) and electrocardiograms.
Time frame: 7 days post-injection
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