Validation of an Intracycle CT Motion CORrection Algorithm for Diagnostic AccuracY: A Prospective Multicenter Study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- MDDX LLC
- 入组人数
- 218
- 试验地点
- 7
- 主要终点
- Diagnostic Accuracy
研究概览
简要总结
To demonstrate the incremental utility of SSF for individuals undergoing CCTA, with expected improvements in image quality and diagnostic accuracy.
详细描述
Hypothesis
Coronary CT angiography (CCTA) employing a novel intracycle motion compensation algorithm (SnapShot Freeze [SSF]) will be superior to CCTA without an intracycle motion compensation algorithm ("conventional" CCTA) for diagnostic accuracy and image quality.
Scientific Basis: Preliminary study (Leipsic, Min, Journal of Cardiovascular Computed Tomography [in press]) of coronary CT angiograms in individuals undergoing pre-procedural assessment for transcatheter aortic valve replacement (n=36) demonstrate improved image quality of CCTA using SSF compared to CCTA not using SSF. Importantly, individuals in this study did not receive heart rate slowing agents (e.g., beta blockers), and diagnostic image quality was substantially improved. While not statistically powered on a per-patient basis, per-segment diagnostic accuracy of CCTA using SSF was superior to conventional CCTA. These results are complementary to those derived from internal testing at GE Healthcare wherein phantom work has demonstrated improved diagnostic performance using SSF compared to conventional image acquisitions.
Long-term Goal/Purpose: To demonstrate the incremental utility of SSF for individuals undergoing CCTA, with expected improvements in image quality and diagnostic accuracy. If the aims of this study are achieved, the use of SSF for effective temporal resolution improvement may obviate (or reduce) the need for CT hardware for improved temporal resolution.
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
- •Consenting adult patients ≥18 years of age;
- •Suspected but without known prior history of CAD
- •Not actively taking heart rate lowering agents at least 48 hours prior to study (e.g., AV nodal blockers such as beta blockers, calcium channel blockers or digoxin)
- •Glomerular filtration rate >60 ml/min
- •CCTA and ICA within 1 week of each other with no interscan event (e.g., myocardial infarction or coronary revascularization)
排除标准
- •Incomplete ICA or CCTA;
- •Known CAD (prior myocardial infarction, PCI, CABG)
- •Atrial Fibrillation
- •Abnormal Renal Function (GFR <60 ml/min)
- •Unwilling or unable to give consent
- •Non-cardiac illness with life expectancy <1 year
- •Concomitant participation in another clinical trial in which subject is subject to investigational drug or device
- •Pregnant women
- •Allergy to iodinated contrast agent
- •Contraindications to nitroglycerin
- •Systolic blood pressure ≤90 mm Hg
- •Contraindications to β blockers or nitroglycerin
结局指标
主要结局
Diagnostic Accuracy
时间窗: 30 days
To compare the per-patient, per-vessel and per-segment diagnostic accuracy of CCTA with SSF to conventional CCTA, as compared to invasive quantitative coronary angiography.
Diagnostic Interpretability
时间窗: 30 days
To compare the per-patient, per-vessel and per-segment diagnostic interpretability of CCTA with SSF to conventional CCTA, as compared to invasive quantitative coronary angiography.
Image quality
时间窗: 30 day
To compare the per-patient, per-vessel and per-segment quantitative image quality of CCTA with SSF to conventional CCTA, as compared to invasive quantitative coronary angiography.
次要结局
- incremental & additive value(1 day)
- Upper threshold of heart rate(1 day)