Standard vs. 3-Dimensional Coronary Angiography: a Paired Comparison Using Intra-Coronary Marker Wires as Matched-Comparison "Gold Standard"
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 发起方
- 入组人数
- 36
- 试验地点
- 2
- 主要终点
- standard coronary angiography over/underestimates the length of the coronary segment evaluated.
研究概览
简要总结
Aim of this study is to evaluate whether the length of coronary segments, assessed by an experienced operator, using the "optimal view" of standard 2-dimensional coronary angiography, is over/underestimated with respect to the one evaluated automatically with the help of a 3-dimensional coronary reconstruction model. Moreover, both techniques are compared with an "in-vivo" surrogate of the real length of the coronary segment under evaluation, i.e. an intra-coronary marker guide-wire, which is a wire with markers placed at fixed and known distance along its length in its distal (intra-coronary) part. Two hypotheses are tested: (1) the length of a coronary segment evaluated with a standard 2-dimensional "optimal view" over/underestimates the length assessed by a 3-dimensional coronary model that automatically detects the least foreshortened length of the segment under evaluation, and (2) the 3-dimensional model approximates more closely than standard 2-dimensional angiography, the real length of the segment detected by the marker guide-wire.
详细描述
The potential to improve the accuracy of the assessment of the coronary tree by means of 3-D modeling reconstruction may lead to an evaluation of the coronary artery anatomy that approximates more correctly the real anatomy, thus subsequently leading to a more tailored diagnosis and therapy for the patients with ischemic heart disease.
Aim of the current study is to assess whether a 3-D model of the coronary tree offers a less foreshortened and less operator-dependent evaluation of the length of the coronary arteries with respect to standard coronary angiography. Furthermore, for the first time "in-vivo", a comparison with the "real" length of the vessel will be performed using as "gold standard" an intra-coronary guide-wire with radiopaque markers at fixed and known distance one from the other along its distal part.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Single Group
- 主要目的
- Diagnostic
- 盲法
- None
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.
- •Ability to give informed consent.
- •Clinical evidence of coronary artery disease:
- •recent (< 72 hours) acute myocardial infarction,
- •stable angina with documented positive stress test,
- •unstable angina with documented ischemia (positive ECG or troponin test or documented positive stress test).
- •Angiographic
- •Eligibility for PCI in at least one de-novo stenosis in a native coronary artery, after the index angiogram.
- •Planned PCI according to a previous coronary angiogram.
排除标准
- •Pregnancy.
- •Chronic or acute renal failure (serum creatinine > 1.8 mg/dL or hemodialysis).
- •Urgent procedure (a procedure carried out before the next referring day, for example for acute myocardial infarction, unstable angina refractory to medical therapy or cardiogenic shock).
- •Contraindications or known hypersensitivity to contrast media.
- •Enrollment in another study protocol.
- •Angiographic
- •Significant left main coronary artery disease.
- •PCI for a total occlusion of a major coronary vessel (LAD, LCX or RCA).
- •Extensive thrombotic burden in a coronary lesion (thrombus grade 3/4).
- •TIMI flow <3 distal to the lesion.
结局指标
主要结局
standard coronary angiography over/underestimates the length of the coronary segment evaluated.
时间窗: peri-procedural
次要结局
- The length of the segments, evaluated with standard and 3-D angiography, will be compared with the length of the segment measured with the marker guide-wire.
- Each group of the same vessel(LAD, RCA, CX) will be evaluated separately.
- All the QCA results of standard angiography will be compared with those of 3-D angiography, in particular in the segments where the lesion is.
- The percentage of vessel foreshortening of the standard angiography operator-selected "working view" will be compared to the least foreshortened view automatically selected with the 3-D angiography reconstruction.