Ultra-High Resolution CT vs. Conventional Angiography for Detecting Hemodynamically Significant Coronary Artery Disease - The Core-PRECISION MULTI-CENTER STUDY
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 175
- 试验地点
- 4
- 主要终点
- Number of patients with hemodynamically significant coronary heart disease
研究概览
简要总结
Cardiac catheterization with invasive coronary angiography is the gold standard for determining the presence or absence of significant coronary heart disease (CHD). However, cardiac catheterization is costly and, as an invasive procedure, it is associated with some risk of adverse events, rarely even stroke, myocardial infarction, or death. Recent advances in multi-detector computed tomography angiography (CTA) have allowed rapid, noninvasive coronary artery imaging in patients with suspected CHD. CTA generally yields high accuracy for identifying patients with CHD when compared to cardiac catheterization. However, diagnostic accuracy is reduced in the setting of severe coronary artery calcification and coronary stents due to its inferior spatial resolution compared to cardiac catheterization. Because high-risk patients often have severe coronary calcification or stents, the application of CTA has been particularly limited in this important patient group. Recently, an ultrahigh-resolution CT scanner was released which has shown promise to overcome the limitation of conventional CTA in the setting of severe coronary artery calcification or stents. This ultrahigh-resolution "precision" CT scanner (UHR-CT) contains detector rows with half the width than currently available systems (0.25 mm vs. 0.5 mm) resulting in approximately twice the spatial resolution.
The purpose of this investigation is to test the hypothesis that high-resolution CTA is not inferior to the current standard of cardiac catheterization for identifying significant CHD in patients with high-risk characteristics, including severe coronary artery calcification and coronary stents.
The investigators propose to enroll 50 patients over 24-30 months in this investigation as part of a multicenter study. Patients referred for cardiac catheterization with known CHD and suspected obstructive coronary artery stenosis will be included. All patients will undergo both cardiac catheterization and UHR-CT for determining significant CHD as defined by coronary functional assessment. The primary end point will be the diagnostic accuracy by area-under-curve (AUC) method for identifying patients with hemodynamically significant CHD.
详细描述
1. Objectives:Primary Objective The primary objective of this study is to generate preliminary data in support of the hypothesis that noninvasive UHR-CT is not inferior to invasive coronary angiography by cardiac catheterization for identifying patients with hemodynamically significant CHD.
Secondary Objectives Secondary objectives include testing the diagnostic accuracy of UHR-CT vs. cardiac catheterization on a vessel and segment-based analysis, comparison of UHR-CT Fractional Flow Reserve (FFR) to conventional angiography, and comparison of adverse events and radiation doses between the CT and conventional angiography groups.
Patient-Based Hypotheses
- Diagnostic accuracy of UHR-CT using visual assessment of coronary artery disease is non-inferior to invasive, conventional coronary angiography for identifying patients with hemodynamically significant CHD defined by an FFR or QFR-value of <0.8 in at least one vessel of 2.0 mm or larger in diameter.
- Diagnostic accuracy of UHR-CT using quantitative assessment of coronary artery disease is non-inferior to invasive, conventional coronary angiography for identifying patients with hemodynamically significant CHD defined by an FFR-value of <0.8 in at least one vessel of 2.0 mm or larger in diameter.
- UHR-CT coronary angiography is associated with lower radiation dose than conventional, invasive coronary angiography.
- UHR-CT coronary angiography is associated with lower adverse effects than conventional, invasive coronary angiography.
Vessel Based Hypotheses
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Diagnostic
- 盲法
- None
入排标准
- 年龄范围
- 45 Years 至 85 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients aged 45-85 years with history of CHD will be asked to participate. History of CHD is defined as prior documentation of a coronary artery stenosis of 50% or greater by coronary angiography or by prior documentation of coronary artery revascularization by percutaneous coronary intervention (PCI). Women of child bearing potential must demonstrate a negative pregnancy test within 24 hours of the study CTA.
- •Suspected obstructive coronary artery stenosis based on clinical history and/or noninvasive testing, prompting a clinical referral for invasive coronary angiography; and/or planned PCI within the next 60 days.
- •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
- •Previous coronary artery bypass or other cardiac surgery
- •Patients without a history of CHD who had no or only mild coronary calcification on chest CT imaging within the past 5 years or had most recent coronary calcium scan with a score <400
- •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
CT Angiography
Research CT angiography.
干预措施: CT angiography (Diagnostic Test)
Conventional Angiography
Standard medical care which includes cardiac catheterization and invasive coronary angiography.
干预措施: Invasive coronary angiography (Diagnostic Test)
结局指标
主要结局
Number of patients with hemodynamically significant coronary heart disease
时间窗: Up to 24 months
The primary analysis will be a comparison of the diagnostic capability of the UHR-CT angiography to conventional coronary angiography at the patient level with the reference standard being coronary flow reserve assessment by either fractional flow reserve (FFR) or quantitative flow reserve (QFR). A positive patient will be defined as having at least one vessel with a flow reserve \<0.8. If both assessments are available for the same vessel, the FFR will be used as reference.
Percentage of Correctly Classified Coronary Artery Disease Patients (True Positives and True Negatives)
时间窗: Up to 90 days
The primary outcome was the patient-level diagnostic accuracy of ultra-high-resolution computed tomography (UHR-CT) compared with invasive coronary angiography (ICA) for identifying hemodynamically significant coronary artery disease (CAD), using quantitative flow ratio (QFR ≤0.80) as the reference standard. For each patient, the highest-grade stenosis across all coronary vessels determined by UHR-CT and ICA was used to classify the test result. Diagnostic accuracy was defined as the percentage of correctly classified patients (true positives and true negatives) relative to QFR.
次要结局
- Number of adverse outcomes(Up to 24 months)
- Number of coronary arteries with abnormal fractional flow reserve(Up to 24 months)
- Radiation Dose(At the time of diagnostic procedure, up to 30 minutes)
- Sensitivity, Specificity, and Accuracy of UHR-CT and ICA(Up to 90 days)
- Percentage Agreement Between UHR-CT and ICA(Up to 90 days)
- Accurately Detected Functionally Significant Stenosis(Up to 90 days)