Dual-acquisition of Noninvasive Cardiac Imaging in Vasospastic Angina Korean Registry
试验速览
- 阶段
- 不适用
- 入组人数
- 90
- 试验地点
- 2
- 主要终点
- Safety and Tolerability
研究概览
简要总结
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 in multi detector-row computed tomography angiography (MDCTA) evaluation has high diagnostic accuracy to evaluate coronary artery stenosis. However, previous report assessing imaging findings or diagnostic accuracy of MDCTA in patients with vasospastic angina (VSA) is lacking.
详细描述
Previously investigators analyzed the characteristics of coronary spasm segment in an observational individual dataset, suspected VSA patients (n=20) underwent dual-acquisition of MDCTA (initial and intravenous nitrate injected CT imaging), the diagnostic accuracy showed sensitivity: 73%, specificity: 100%, positive predictive value: 100%, and negative predictive value: 56%.
Further study is necessary because previous analysis presented limited sample size and deficiency of healthy control.
Therefore, investigators hypothesis that dual-acquisition of MDCTA in noninvasive tool for coronary assessment provide more information of coronary characteristics, and the diagnostic efficacy would be non-inferior as compared with the invasive coronary imaging modality in coronary spasm-induced angina attacks.
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
- 20 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Subject is onset of angina-like attack at rest, during effort, or during rest and effort.
- •Subject has chest pain between night and early morning.
- •Subject is scheduled to undergo MDCTA.
- •Subject is an acceptable candidate for CAG with an EG provocation test.
- •Cardiac condition: BP>90/60mmHg, ECG: sinus rhythm with regular, left ventricular ejection fraction>55%, and resting heart rate<100 beats/min.
- •Subject will be provided written informed consent.
- •Subject is willing to comply with study follow-up requirement.
排除标准
- •Subject has clinical evidence of acute coronary syndrome.
- •Subject has evidence of significant narrowing (>50% stenosis by CAG).
- •Subject has clinical evidence of cardiomyopathy or valvular heart disease.
- •Subject is hemodynamically unstable.
- •Subject has a history of PCI and CABG.
- •Subject is pregnant and/or breastfeeding or intends to become pregnant during the duration of the study.
- •Subject has known allergy to contrast medium.
- •Subject has renal insufficiency (serum creatine >2.5 mg/dl).
结局指标
主要结局
Safety and Tolerability
时间窗: 3 days
MDCTA procedure: all subjects will undergo MDCTA without a vasodilator ("initial CT") in the early morning before the ergonovine provocation spasm test. Subsequent "IV nitrate CT" will be allowed at a 3-day washout period after the first contrast usage. The scan protocol for the IV nitrate CT is as follows: during continuous injection of the intravenous vasodilating agent (isosorbidedinitrate 2 mg/hr), blood pressure will be checked every 2 minutes. When both the systolic and diastolic blood pressure decrease by 10 mmHg in comparison to the initial value, the CT scan initiate and images will be acquired during the nitrate infusion. Investigators define the positive criteria for VSA on MDCTA as follows: 1. Significant stenosis (≥ 50%) with negative remodeling but no definite evidence of plaques, which completely dilated on IV nitrate CT, or 2. Diffuse small diameter (\< 2mm) of a major coronary artery with beaded appearance which completely dilated on IV nitrate CT.
次要结局
- Cutoff value of coronary vessel distensibility index(3 days)
- Characteristics of spasm-related coronary artery segment(3 days)
- Incidence of multi-vessel spasm(3 days)
- Coronary vessel distensibility(3 days)
- Diagnostic accuracy of MDCTA(3 days)
研究者
Moo Hyun Kim
Professor, Dept. of Cardiology, Dong-A University Hospital
Dong-A University