Multi-Center Evaluation of Feasibility of SPECT Measurement of Myocardial Blood Flow and Reserve
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 35
- 试验地点
- 7
- 主要终点
- Correlation in MBF Between Core Laboratory and Local Site
研究概览
简要总结
Patients will be recruited from those referred to the local site's Diagnostic Imaging Department for SPECT myocardial perfusion imaging (MPI) ,who have an intermediate to high pre-test likelihood of disease (Diamond-Forrester criteria ≥ 30%) and are clinically indicated to have an MBF study.
详细描述
Patients will be recruited from those referred to the local site's Diagnostic Imaging Department for SPECT myocardial perfusion imaging (MPI), who have an intermediate to high pre-test likelihood of disease (Diamond-Forrester criteria ≥ 30%) and are clinically indicated to have an MBF study. Research imaging will consist of a SPECT acquisition at the time of rest and stress radiotracer injection in addition to the standard (delayed) clinical stress/rest SPECT scan with 99mTc-tetrofosmin. This is an observational study; patients will be managed according to the standard clinical care of the local site. Where available, a CT scan will also be acquired for attenuation and/or scatter correction. Studies may be one day (rest/stress or stress/rest) or two day (rest and stress on separate days) All studies will be analyzed locally but the raw data will also be anonymized and forwarded to the core facility for reprocessing. Central processing will allow comparison between sites and the repeat processing will provide an estimate of inter-operator variability in the measurements. The core lab will also compare the relative perfusion from immediate and delayed imaging for image quality and diagnostic accuracy (visual and quantitative).
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
- •Age ≥ 18 years old
- •BMI ≤ 40 kg/m2
- •Able and willing to comply with the study procedures
- •Written informed consent
- •Intermediate to high probability of CAD
- •Suspected or known CAD on a stable medication regime
排除标准
- •History or risk of severe bradycardia (heart rate < 50 beats per minute) not related to chronotropic drugs
- •Known second- or third-degree AV block without pacemaker
- •Dyspnea (NYHA III/IV), wheezing asthma or COPD
- •Coronary artery bypass graft (CABG) surgery within 60 days prior to screening or within 45 days after consent (early revascularization)
- •Percutaneous coronary intervention (PCI) within 30 days prior to screening or within 45 days following consent (early revascularization)
- •Recent use of dipyridamole, dipyridamole-containing medications (e.g. Aggrenox)
- •Known hypersensitivity to dipyridamole or adenosine
- •Breastfeeding or pregnancy
- •Claustrophobia or inability to lie still in a supine position
- •Unwillingness or inability to provide informed consent
结局指标
主要结局
Correlation in MBF Between Core Laboratory and Local Site
时间窗: The average total amount of time that the patient was assessed for the MBF protocol varied between 71 and 122 minutes.
MBF was measured locally and at a core laboratory using commercially available software. The acquisition protocol was standardized between the local site and core laboratory. a one-day rest-stress protocol was used. Relative perfusion images were obtained after tracer injection. All raw study data were transferred to the core laboratory where processing was independently repeated by one reader to evaluate inter site processing consistency. Perfusion scores were compared with the measured MBF.
次要结局
- Impact on Throughput(The average total time the patient was in the camera room during the study protocol was 72.28 minutes.)