Incremental Value of Signal Processed Surface Electrocardiography (IECG) for Detecting Ischemic Heart Disease: Comparison With Computed Tomography Coronary Angiography (CTCA)
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 1,000
- 试验地点
- 1
- 主要终点
- Comparison between Myovista iECG findings and CTCA (gold standard) results
研究概览
简要总结
Study evaluates the new technique MyoVista™ iECG sensitivity and ability to predict myocardial diseases, comparing iECG results with Computed Tomography Coronary Angiography findings
详细描述
Clinical need
Non-invasive identification of patients with coronary artery disease using a single, highly reliable technique is challenging. Computed tomography coronary angiography (CTCA) has emerged as a patient-friendly, accurate diagnostic tool. Compared to invasive coronary angiography, the sensitivity and specificity of CTCA for detecting significant coronary stenosis has been reported to be higher than 90%. Moreover, CTCA allows the detection of nonobstructive coronary plaques (CAPs). However, the advantage of CTCA is frequently reduced by significantly higher radiation exposure.
New MyoVista™ iECG technology
The MyoVista™ (Heart Test Laboratories Inc., Colleyville, TX, USA) is a novel electrocardiographic device. The clinical set up of MyoVista™ is identical to that of a traditional 12-lead ECG but it acquires and processes signal information in a way that permits much greater resolution of the electrical activity associated with the myocardium (iECG). This technology property of Heart Test Laboratories allows analysis of the entire myocardium and provides visual indicators and waveforms for clinical evaluation.
Study rationale
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •chest pain,
- •shortness of breath,
- •syncope or equivocal stress testing including exercise ECG,
- •myocardial perfusion imaging, or stress echocardiography unable to exclude significant coronary artery disease.
- •All patients will provide written and oral consent to CTCA.
- •Patient agrees to participate and signs the informed consent
排除标准
- •usually renal insufficiency (serum creatinine >120 mol/l),
- •contraindications to the administration of iodinated contrast,
- •pregnancy, acute coronary syndromes,
- •and ventricular and/or supraventricular arrhythmias.
结局指标
主要结局
Comparison between Myovista iECG findings and CTCA (gold standard) results
时间窗: one day
Comparison of findings from the two methods will be made to demonstrate that Myovista iECG is equally effective as CTCA in predicting CAPs and/or CAD in individuals with or without history of cardiovascular disease, in terms of sensitivity, specificity and predictive value
次要结局
未报告次要终点
研究者
Angelo Auricchio
Principal Investigator
Cardiocentro Ticino