Back to resultsEvaluation of Exercise Treadmill Test (ETT) Indices in Participants With Cardiovascular Disease
Primary Purpose
Atherosclerotic Coronary Vascular Disease
Status
Terminated
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
Ranolazine 500 mg
Sponsored by
About this trial
This is an interventional other trial for Atherosclerotic Coronary Vascular Disease focused on measuring Cardiovascular disease, Exercise Treadmill Test, Ranolazine, Angina, Myocardial ischemia
Eligibility Criteria
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.
Sites / Locations
- Novartis Investigative Site
- Novartis Investigative Site
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Ranolazine 500 mg
Arm Description
Participants received ranolazine 500 milligrams (mg), orally, twice daily (b.i.d.) up to 14 days.
Outcomes
Primary Outcome Measures
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.
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.
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.
Secondary Outcome Measures
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.
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.
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.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT01562041
Brief Title
Evaluation of Exercise Treadmill Test (ETT) Indices in Participants With Cardiovascular Disease
Official Title
Evaluation of Exercise Treadmill Test Indices in Patients With Cardiovascular Disease
Study Type
Interventional
2. Study Status
Record Verification Date
May 2021
Overall Recruitment Status
Terminated
Study Start Date
March 9, 2012 (Actual)
Primary Completion Date
January 2, 2014 (Actual)
Study Completion Date
January 2, 2014 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Novartis Pharmaceuticals
4. Oversight
Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief Summary
The study was designed to evaluate the use of ETT electrocardiogram (ECG) indices as biomarkers in the assessment of atherosclerotic coronary vascular disease (ASCVD).
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Atherosclerotic Coronary Vascular Disease
Keywords
Cardiovascular disease, Exercise Treadmill Test, Ranolazine, Angina, Myocardial ischemia
7. Study Design
Primary Purpose
Other
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
14 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Ranolazine 500 mg
Arm Type
Experimental
Arm Description
Participants received ranolazine 500 milligrams (mg), orally, twice daily (b.i.d.) up to 14 days.
Intervention Type
Drug
Intervention Name(s)
Ranolazine 500 mg
Other Intervention Name(s)
Ranexa®
Intervention Description
Ranolazine 500 mg, oral tablet, b.i.d.
Primary Outcome Measure Information:
Title
Change From Baseline in Maximum ST Segment Change Adjusted for Heart Rate (ST-HR) Index
Description
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.
Time Frame
Baseline up to Day 15
Title
Change From Baseline in Maximum ST Segment Change Adjusted for Heart Rate (ST-HR) Slope
Description
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.
Time Frame
Baseline up to Day 15
Title
Change From Baseline in X-Axis Intercept of ST-HR Slope
Description
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.
Time Frame
Baseline up to Day 15
Secondary Outcome Measure Information:
Title
Change From Baseline in Total Exercise Duration
Description
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.
Time Frame
Baseline up to Day 15
Title
Change From Baseline in Time to Onset of 1 mm ST Segment Depression (Time to Ischemia)
Description
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.
Time Frame
Baseline up to Day 15
Title
Change From Baseline in Time to Onset of Angina
Description
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.
Time Frame
Baseline up to Day 15
10. Eligibility
Sex
All
Minimum Age & Unit of Time
40 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Novartis Pharmaceuticals
Organizational Affiliation
Novartis Pharmaceuticals
Official's Role
Study Director
Facility Information:
Facility Name
Novartis Investigative Site
City
Jacksonville
State/Province
Florida
ZIP/Postal Code
32216
Country
United States
Facility Name
Novartis Investigative Site
City
New York
State/Province
New York
ZIP/Postal Code
10021
Country
United States
12. IPD Sharing Statement
Learn more about this trial
Evaluation of Exercise Treadmill Test (ETT) Indices in Participants With Cardiovascular Disease
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