Evaluation of Exercise Treadmill Test (ETT) Indices in Participants With Cardiovascular Disease

Study Overview
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Brief Summary
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The study was designed to evaluate the use of ETT electrocardiogram (ECG) indices as biomarkers in the assessment of atherosclerotic coronary vascular disease (ASCVD).

Official Title
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Evaluation of Exercise Treadmill Test Indices in Patients With Cardiovascular Disease

Conditions
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Atherosclerotic Coronary Vascular Disease

Intervention / Treatment
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* Drug: Ranolazine 500 mg


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: History of stable coronary artery disease Exclusion Criteria: 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.

Ages Eligible for Study
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Minimum Age: 40 Years
Maximum Age: 75 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Other
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Ranolazine 500 mg<br>Participants received ranolazine 500 milligrams (mg), orally, twice daily (b.i.d.) up to 14 days. | Drug: Ranolazine 500 mg<br>* Ranolazine 500 mg, oral tablet, b.i.d.<br>* Other names: Ranexa®;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change From Baseline in Maximum ST Segment Change Adjusted for Heart Rate (ST-HR) Index | 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. | Baseline up to Day 15 | 
| Change From Baseline in Maximum ST Segment Change Adjusted for Heart Rate (ST-HR) Slope | 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. | Baseline up to Day 15 | 
| Change From Baseline in X-Axis Intercept of ST-HR Slope | 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. | Baseline up to Day 15 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change From Baseline in Total Exercise Duration | Total exercise duration was defined as the elapsed time between the start of exercise and termination of exercise for severe angina, dyspnea or extreme fatigue assessed during the exercise treadmill test. Change in the duration of exercise 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. | Baseline up to Day 15 | 
| Change From Baseline in Time to Onset of 1 mm ST Segment Depression (Time to Ischemia) | Exercise-induced ischemia was defined as the new development of horizontal or down sloping ST-segment depression (≥ 1 mm at 60 milliseconds after the J point) vs. baseline tracings. Change in time to onset of 1 mm ST depression 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. | Baseline up to Day 15 | 
| Change From Baseline in Time to Onset of Angina | Time to onset of angina was defined as the elapsed time between the start of exercise and the onset of anginal chest pain as reported by the participant. Change in time to angina 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. | Baseline up to Day 15 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Cardiovascular disease, Exercise Treadmill Test, Ranolazine, Angina, Myocardial ischemia