Diagnostic Benefits of HyperQ™ vs. Conventional ECG During Stress Test. A Comparison Study in Patients Referred for Angiography
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 200
- 试验地点
- 1
- 主要终点
- The primary objective of this study is to determine the incremental diagnostic value of HyperQ data over exercise stress testing parameters to detect significant coronary artery disease (CAD) in patients referred for coronary angiography.
研究概览
简要总结
The purpose of the investigation is to verify the efficiency of the HyperQ™ system in detecting exercise induced ischemia, with higher specificity and sensitivity than conventional ECG Stress testing. The study will be carried out by applying the HyperQ™ system during cycle ergometer stress testing in patients who are referred for angiography at the Department of Cardiology, Essen University Hospital, Essen, Germany. The HyperQ™ results will then be compared to the standard ECG stress test results using the angiography results as the gold standard. The study will be considered successful if analysis of the HyperQ provides a statistically significant improvement over the diagnostic accuracy of conventional ECG stress testing analysis.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Only
- 时间视角
- Prospective
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
- •A patient who was referred to angiography.
- •A patient who is able (i.e., no contraindications) to perform an exercise stress test
- •A patient who signed an informed consent form.
排除标准
- •Contraindications for an exercise test.
- •Wolff-Parkinson-White (pre-excitation) syndrome.
- •Left Bundle branch block, Complete Right bundle branch block or QRS duration > 120 ms, change in QRS morphology during exercise.
- •Atrial Fibrillation or significant ventricular arrhythmia
- •Treatment with Digoxin.
- •Pacemaker.
- •Having taken beta blockers within 24 hours before the exercise test.
- •Pregnancy or suspected pregnancy.
结局指标
主要结局
The primary objective of this study is to determine the incremental diagnostic value of HyperQ data over exercise stress testing parameters to detect significant coronary artery disease (CAD) in patients referred for coronary angiography.
时间窗: 1 week
次要结局
未报告次要终点
研究者
N. Reinsch
Principal Investigator
West German Heart Center Essen