Ultra-High Resolution Computed Tomography (CT) vs. Conventional CT for Detecting Obstructive Coronary Artery Disease (CAD) The CORE-COMPARE Pilot Study
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 140
- 试验地点
- 2
- 主要终点
- agreement between the number of patients with >70% stenosis detected by ultra-high-resolution tomography compared to conventional tomography, with catheterization considered as the gold standard.
研究概览
简要总结
The utility of Ultra High-Resolution Computed Tomography (UHR-CT) compared to conventional CT in all-comers (i.e., a generally lower-risk population) remains uncertain but is an important area of study in order to justify wider spread implementation and use of this technology, particularly in light of reports of significantly higher radiation exposure with UHR-CT, as well as longer scan times. The availability of technology to reconstruct conventional resolution (CR) simulation images from the raw CT acquisition data acquired on the UHR-CT scanner offers a unique platform to study this question without subjecting individuals to two different scans.
The primary objective of this study is to generate preliminary data in support of the hypothesis that noninvasive UHR-CT is superior to conventional resolution CT for identifying patients with obstructive CHD.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Other
- 盲法
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 21 Years 至 85 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients aged 21-85 years
- •Clinical history suggestive of CHD who are referred by their primary cardiologist for further evaluation via Computed tomography angiography (CTA) will be asked to participate.
- •Women of child bearing potential must demonstrate a negative pregnancy test within 24 hours of the study CTA.
- •Ability to understand and willingness to sign the Informed Consent Form.
排除标准
- •Known allergy to iodinated contrast media.
- •History of multiple myeloma or previous organ transplantation
- •Elevated serum creatinine (> 1.5mg/dl) OR calculated creatinine clearance of < 60 ml/min (using the Cockcroft-Gault formula
- •Atrial fibrillation or uncontrolled tachyarrhythmia, or advanced atrioventricular block (second or third degree heart block)
- •Evidence of severe symptomatic heart failure (NYHA Class III or IV);
- •Known or suspected moderate or severe aortic stenosis
- •History of prior percutaneous coronary intervention (PCI) in one or more vessel or history of coronary arterial bypass grafting (CABG)
- •Suspected acute coronary syndrome
- •Presence of any other history or condition that the investigator feels would be problematic
研究组 & 干预措施
UHR-CT (Ultra-High-Resolution Computed Tomography-Aquilion Precision)
Participants in this arm undergo CT scans using the Ultra-High-Resolution CT imaging modality.
干预措施: Aquilion Precision (Device)
CR-CT (Conventional Resolution Computed Tomography)
Participants in this arm receive CT scans using the Conventional Resolution CT imaging modality.
干预措施: Conventional Computed Tomography (Device)
结局指标
主要结局
agreement between the number of patients with >70% stenosis detected by ultra-high-resolution tomography compared to conventional tomography, with catheterization considered as the gold standard.
时间窗: Up to 24 Months
The ultra-high-resolution CT images (UHRCT) and the reconstructed conventional CT resolution images (CRCT) will be independently reviewed by two observers (with a 60-day washout period between both images). The stenoses will be classified according to the Society of Cardiovascular Computed Tomography (SCCT) classification system (\<25%, 25-49%, 50-69%, 70-99%, and occluded). Patients with stenosis greater than 70% will be flagged. The primary outcome will be assessed for patients that underwent a clinically indicated invasive angiography (ICA). To compare agreement between UHRCT and CRCT studies while using ICA as the gold-standard, a concordance meta-analysis will be employed. This involves evaluating the agreement measures from each study, standardizing the results, and then comparing the concordance results of the two studies with the third study, considered the gold standard.
次要结局
- Pericoronary Adipose Tissue Analysis:(Up to 24 Months)
- Segment-Based Analysis for Obstructive Stenosis:(Up to 24 Months)
- Interobserver Variability Analysis:(Up to 24 Months)
- Assessment of vascular and plaque metrics:(Up to 24 Months)
- Diagnostic Confidence Assessment:(Up to 24 Months)