Multidimensional Wavelet Analysis of Surface Electrocardiogram for Identifying Subclinical Myocardial Dysfunction in Patients at Risk for Coronary Artery Disease
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 200
- 试验地点
- 1
- 主要终点
- Colorized waveform
研究概览
简要总结
- The MyoVista device is capable of detecting surface electrocardiogram signals and sensitive in detecting coronary artery disease compared to traditional computed tomography angiography (CTA)
- Electrophysiological signals at the cellular level of myocardium are related to specific patterns on the MyoVista device
- Changes in MyoVista device output and can indicative of future CAD outcomes and need for revascularization
详细描述
Background Myocardial ischemia is caused by myocardial oxygen supply and demand mismatch. Despite that coronary artery disease (CAD) is the major cause of myocardial ischemia, the symptoms may occur even in the absence of significant CAD. One of the mechanisms suggested for myocardial ischemia in these patients is microvascular ischemia (i.e. mismatch in microscopic vessels), affecting the myocardium (i.e. heart muscle) at the cellular level.
A novel electrocardiographic recording method, the iECG is capable of capturing and amplifying signals from the cellular level that are much lower biologic signals than those processed by a traditional electrocardiogram (ECG). These recordings focus on early detection of myocardial abnormalities by non-linear analysis of electrical activity and physiological phenomenon. This novel assessment might be capable of detecting subclinical myocardial dysfunction in a variety of heart diseases.
Specific Aims
Aim#1: Study the feasibility of detection of CAD using iECG compared to computed tomographic coronary angiography (CTA).
Aim#2: Study the association between patterns of iECG and myocardial dysfunction in patients without CAD compared to echocardiography.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Device Feasibility
- 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
- •Sinus rhythms
- •Age>18 years
- •Both genders
排除标准
- •Acute coronary syndromes(ACS)
- •Contraindications to the administration of iodinated contrast
- •Pregnancy
- •Coronary artery bypass surgery (CABG)
- •History of cardiac valvular replacement
- •Implanted cardiac pacemaker
- •Chest deformities
- •Unwilling or unable to provide informed consent for study participation
- •Enrolled in another clinical study
研究组 & 干预措施
Coronary artery disease
Patients scheduled for computed tomographic coronary angiography (CTA)
干预措施: MyoVista device (Device)
Coronary artery disease
Patients scheduled for computed tomographic coronary angiography (CTA)
干预措施: Computed tomographic coronary angiography (Device)
Coronary artery disease
Patients scheduled for computed tomographic coronary angiography (CTA)
干预措施: Transthoracic Echocardiography (Device)
结局指标
主要结局
Colorized waveform
时间窗: Day 1
Spectrum analysis to represent levels and locations of cellular energy and automates the analysis into a simple indication of the level of myocardial abnormality if present.
次要结局
- Change in coronary plaque burden(Baseline and 3 months)
- Myocardial wall motion score index (WMSI)(Baseline)
- Serum electrolytes(3 months)
- Serum cardiac enzymes(3 months)
- Serum creatinin level(3 months)
- Serum Brain natriuretic peptide (BNP) level(3 months)
- Serum high sensitivity C-reactive protein (hsCRP)(3 months)
研究者
Partho Sengupta
Associate Professor of Medicine and Director of Cardiac Ultrasound Research and Core Lab
Icahn School of Medicine at Mount Sinai