Diagnostic Usefulness of Multidetector Coronary CT in Vasospastic Angina
试验速览
- 阶段
- 不适用
- 入组人数
- 150
- 试验地点
- 2
- 主要终点
- Characteristics of coronary lesion
研究概览
简要总结
The purpose of this study is to compare the extent of coronary vessel stenosis between coronary spasm-induced angina attacks (named vasospastic angina, VSA) patients and health volunteers by multi-detector computed tomography angiography (MDCTA), and to evaluate the diagnostic efficacy of MDCTA in patients with VSA.
详细描述
Vasospastic angina (VSA) was characterized by transient ischemic ST-segment change during angina attacks. Coronary spasm provocation test, as a diagnostic golden standard, has been widely used for the management of VSA according to JCS 2013 guidelines.
With regard to the characteristics of spasm segment, had been clearly described by other invasive imaging methods including intravascular ultrasound and optical coherence tomography. However, there is potential risk during these invasive procedures, such as severe myocardial ischemia or fatal arrhythmia.
Presently available imaging test for coronary artery disease including multi-detector computed tomography angiography (MDCTA) with high diagnostic accuracy to evaluate coronary artery stenosis. However, the diagnostic accuracy of MDCTA in patients with VSA is lacking.
Therefore, more efficient and safe noninvasive diagnostic method is required for the detection of angina-like attacks patients.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Diagnostic
- 盲法
- Single (Participant)
入排标准
- 年龄范围
- 20 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Onset of angina-like attack at rest, during effort, or during rest and effort.
- •Patients will be scheduled to undergo multi-detector computed tomography angiography and coronary angiography with an ergonovine provocation test.
排除标准
- •Evidence of acute coronary syndrome, cardiomyopathy and valvular heart disease.
- •More than 50% stenosis detected by coronary angiography .
- •Renal insufficiency (serum creatine>2.5 mg/dl).
结局指标
主要结局
Characteristics of coronary lesion
时间窗: CAG will be performed after multidetector coronary CT, an expected average of 4 weeks.
1. Plaque composition: noncalcified plaque, which is \< 130 Hounsfield units(HU). Calcified plaque with a density of \> 130 HU. Mixed plaque: plaque area consisted of \> 50% of non-calcified plaque. 2. The remodeling index (RI) was calculated by dividing the cross-sectional lesion vessel-area by the reference vessel area.Positive remodeling was defined as RI \> 1.05, otherwise RI ≤0.95. 3. Significant stenosis is defined as stenosis in more than 50% of the coronary artery diameter.
次要结局
未报告次要终点
研究者
Moo Hyun Kim
M.D. Director, Regional Clinical Trial Center. Professor, Dept. of Cardiology Dong-A Unicersity Hospital
Dong-A University