Quantitative Rest/Stress Cardiac Perfusion Digital PET/CT: Comparison Between Noninvasive Imaging and Invasive Coronary Angiography.
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 15
- 试验地点
- 1
- 主要终点
- CFR measurement using PET/CT
研究概览
简要总结
Accurate measurements from a non-invasive test like myocardial perfusion positron emission tomography/ computed tomography (PET/CT) may decrease the need for invasive procedures such as cardiac catheterization.The investigators wish to see if the measurements from cardiac catheterization can be predicted using a non-invasive 13N-NH3 digital PET/CT scan.
详细描述
Cardiac imaging using standard-of-care Nuclear Medicine techniques assess the relative radiopharmaceutical distribution from coronary arteries to cardiac tissue. This standard interpretation however, lacks the clinical utility of modern quantitative techniques that are now routinely obtained during cardiac catheterization, such as fractional flow reserve (FFR). Cardiologists routinely base critical management decisions, including the choice for revascularization, stenting, or angioplasty, on these measurements.
Non-invasive measurements of MBF (Myocardial Blood Flow), CFR (Coronary Flow Reserve) and RFR (Relative Flow Reserve) using PET/CT have been investigated, but have yet to reach clinicl use. Given the inherent gains in sensitivity and resolution, digital PET/CT, may allow for a more robust and accurate platform to obtain quantitative measurements of MBF, CFR and RFR which may greatly enhance the clinical utility of cardiac PET/CT for management of coronary artery disease.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patient is ≥ 18 years old at the time of the scan
- •Patient has known or suspected coronary artery disease
- •Patient has had a recent or will be scheduled for a diagnostic coronary angiogram
- •Patient provides written informed consent
- •Patient is referred for myocardial perfusion scan
- •Patient is capable of complying with study procedures
- •Patient is able to remain still for duration of imaging procedure (approximately 60 minutes total for both PET/CT)
排除标准
- •Patients who are pregnant or breast feeding
- •Patients with contraindications to regadenoson
研究组 & 干预措施
N13-ammonia Cardiac Rest/Stress PET/CT
Patients with coronary artery disease (CAD) undergo a Cardiac Perfusion Rest/Stress Digital PET/CT scan using the radiopharmaceutical N13-ammonia and Regadenoson (Lexiscan) to induce pharmacologic stress.
干预措施: Cardiac Perfusion Rest/Stress Digital PET/CT (Diagnostic Test)
N13-ammonia Cardiac Rest/Stress PET/CT
Patients with coronary artery disease (CAD) undergo a Cardiac Perfusion Rest/Stress Digital PET/CT scan using the radiopharmaceutical N13-ammonia and Regadenoson (Lexiscan) to induce pharmacologic stress.
干预措施: N-13 ammonia (Drug)
N13-ammonia Cardiac Rest/Stress PET/CT
Patients with coronary artery disease (CAD) undergo a Cardiac Perfusion Rest/Stress Digital PET/CT scan using the radiopharmaceutical N13-ammonia and Regadenoson (Lexiscan) to induce pharmacologic stress.
干预措施: Regadenoson (Drug)
结局指标
主要结局
CFR measurement using PET/CT
时间窗: an estimated average of 2 hours
Non-invasive measurements of coronary flow reserve (CFR) using digital PET/CT scanner will be compared to the gold standard evaluation from invasive cardiac angiography. Discrepancy between PET measurements and cardiac angiography results will be reported. CFR is the ratio of MBF at peak blood flow to resting MBF.
RFR measurement using PET/CT
时间窗: an estimated average of 2 hours
Non-invasive measurements of relative flow reserve (RFR) using digital PET/CT scanner will be compared to the gold standard evaluation from invasive cardiac angiography. Discrepancy between PET measurements and cardiac angiography results will be reported. RFR is the ratio of MBF during stress in an affected region of the left ventricle (LV) to MBF during stress in a normal region of the LV.
MBF measurement using PET/CT
时间窗: an estimated average of 2 hours
Non-invasive measurements of myocardial blood flow (MBF) in milliliter/minute/gram using PET/CT scanner will be compared to invasive cardiac angiography values (current gold standard). MBF values are obtained using image-derived time activity curves from the left ventricular blood and myocardial tissue regions. These values represent radiotracer exchange between the blood and the tissue over time. The rate of radiotracer uptake into the myocardial tissue provides an estimate of MBF. Processing software will then use the time-activity curves to calculate MBF at rest and at stress.
次要结局
- Overall Exam Time(an estimated average of 2 hours)
- Effective radiation dose(an estimated average of 2 hours)
- NM Physician diagnostic confidence of 13N-NH3 PET/CT(an estimated average of 2 hours)
研究者
Guido A. Davidzon, MD, SM
Clinical Assistant Professor
Stanford University