Cardiac Phase Space Tomography Analysis (cPSTA) System: Coronary Artery Disease Learning and Development Study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 2,622
- 主要终点
- Machine-learned algorithm
研究概览
简要总结
This study is primarily designed to collect resting phase signals from eligible subjects using the Phase Signal Recorder (PSR) prior to coronary angiography to machine learn and test an algorithm for detecting the presence of significant coronary artery disease in symptomatic adult patient.
详细描述
This clinical protocol is primarily designed to collect resting phase signals from eligible subjects using the Phase Signal Recorder (PSR) prior to coronary angiography to machine learn and test an algorithm for detecting the presence of significant coronary artery disease in symptomatic adult patient. In addition to this primary objective, machine-learned algorithms will be developed and tested to report the left ventricular ejection fraction and to identify the location of significant coronary artery disease. The performance of the machine-learned algorithm will be evaluated using a comparative paired trial design. In this study, the physician will not be provided the results of analysis performed and, accordingly, the results of the analyses will not be used to guide treatment decisions for the patient.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Diagnostic
- 盲法
- None
入排标准
- 年龄范围
- 21 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age ≥21 years of age at the time of screening
- •Meets criteria for coronary angiography
- •Scheduled to undergo cardiac catheterization with coronary angiography
- •Ability to understand the requirements of the study and to provide written informed consent
排除标准
- •Prior documented myocardial infarction (MI)
- •Prior coronary artery bypass grafting (CABG) or previous coronary interventions (PCI)
- •Indication for invasive coronary angiography other than to assess for obstructive CAD (e.g., arrhythmia, cardiomyopathy, valvular abnormality)
- •Previous heart valve replacement
- •Previous sustained or paroxysmal atrial or ventricular arrhythmia
- •Infiltrative myocardial disease (Amyloid, Sarcoid, Right ventricular dysplasia)
- •Presence of cardiac implantable electronic device (CIED), including implantable cardioverter defibrillator (ICD), pacemaker (PM), implantable loop recorders and other monitors
- •Implantable Neuro-stimulators
- •Congenital Heart Disease
- •Pregnancy (breast feeding)
- •Currently taking any Type IA, IC or III antiarrhythmic
- •Any history of Amiodarone therapy
- •Clinically significant chest deformity (e.g., pectus excavatum or pectus carnitatum)
- •Breast implants
- •Neuromuscular Disease if the condition results in tremor or muscle fasciculations
研究组 & 干预措施
Enrolled Subjects (PSR)
Patients who meet the study's inclusion and exclusion criteria, including signing the informed consent form, subjects will undergo signal acquisition prior to their scheduled cardiac catheterization on the day of the procedure.
干预措施: Phase Signal Recorder (Device)
结局指标
主要结局
Machine-learned algorithm
时间窗: 7 day
Develop and test a machine-learned algorithm which maximizes the area under the receiver-operating characteristic (AUC-ROC) curve to 0.70 (expected) and clinically significant sensitivity and specificity to detect CAD when compared to clinical diagnosis of significant coronary artery disease (i.e., presence of ≥70% stenosis by angiography or reduced fraction flow of \<=0.80) in at least one of the major coronary arteries (LMA, LAD, RCA, or LCX) or their distributions.
次要结局
未报告次要终点