Evaluation of Exercise Treadmill Test Indices in Patients With Cardiovascular Disease
试验速览
- 阶段
- 2 期
- 状态
- 终止
- 入组人数
- 14
- 试验地点
- 1
- 主要终点
- Change From Baseline in Maximum ST Segment Change Adjusted for Heart Rate (ST-HR) Index
研究概览
简要总结
The study was designed to evaluate the use of ETT electrocardiogram (ECG) indices as biomarkers in the assessment of atherosclerotic coronary vascular disease (ASCVD).
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Other
- 盲法
- None
入排标准
- 年龄范围
- 40 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •History of stable coronary artery disease
排除标准
- •Inability or unwillingness to participate in multiple exercise treadmill tests and/or any other requirements of this study as assessed by the Investigator.
- •History of chronic atrial fibrillation.
- •Other protocol-defined inclusion/exclusion criteria may apply.
研究组 & 干预措施
Ranolazine 500 mg
Participants received ranolazine 500 milligrams (mg), orally, twice daily (b.i.d.) up to 14 days.
干预措施: Ranolazine 500 mg (Drug)
结局指标
主要结局
Change From Baseline in Maximum ST Segment Change Adjusted for Heart Rate (ST-HR) Index
时间窗: Baseline up to Day 15
ST/HR index was measured as the average change in ST segment depression relative to heart rate change over the entire duration of exercise, monitored by ECG during the exercise treadmill tests. Change in maximum ST/HR index between the average of tests 1-3 (pre Ranexa® treatment) performed during baseline period and test 4 (post Ranexa® treatment) during treatment period was reported.
Change From Baseline in Maximum ST Segment Change Adjusted for Heart Rate (ST-HR) Slope
时间窗: Baseline up to Day 15
ST-HR slope is an index of exercise induced ischemia. Linear regression was used to determine the slope of the ST/HR relationship in a participant's ECG response monitored during the exercise treadmill test. The highest ST segment/heart rate slope from among all the ECG leads and the X-axis intercept of the associated line were used to generate the maximum slope. Change in maximum ST-HR slope between the average of tests 1-3 (pre Ranexa® treatment) performed during baseline period and test 4 (post Ranexa® treatment) during treatment period was reported.
Change From Baseline in X-Axis Intercept of ST-HR Slope
时间窗: Baseline up to Day 15
Linear regression was used to determine the slope of the ST/HR relationship in a participant's ECG response monitored during the exercise treadmill test. Change in X- axis intercept of ST-HR slope between the average of tests 1-3 (pre Ranexa® treatment) performed during baseline period and test 4 (post Ranexa® treatment) during treatment period was reported.
次要结局
- Change From Baseline in Total Exercise Duration(Baseline up to Day 15)
- Change From Baseline in Time to Onset of 1 mm ST Segment Depression (Time to Ischemia)(Baseline up to Day 15)
- Change From Baseline in Time to Onset of Angina(Baseline up to Day 15)