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

Evaluation of Exercise Treadmill Test Indices in Patients With Cardiovascular Disease

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

Study Overview

• Status: Terminated
• Conditions: Atherosclerotic Coronary Vascular Disease
• Intervention / Treatment: Drug: Ranolazine 500 mg

• Study Type: Interventional
• Enrollment (Actual): 14
• Phase: Phase 2

Contacts and Locations

Study Locations

• United States
  • Florida
    • Jacksonville, Florida, United States, 32216
      • Novartis Investigative Site
  • New York
    • New York, New York, United States, 10021
      • Novartis Investigative Site

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 40 years to 75 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

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

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Novartis Pharmaceuticals

Study record dates

Study Major Dates

• Study Start (Actual): March 9, 2012
• Primary Completion (Actual): January 2, 2014
• Study Completion (Actual): January 2, 2014

Study Registration Dates

• First Submitted: March 21, 2012
• First Submitted That Met QC Criteria: March 22, 2012
• First Posted (Estimate): March 23, 2012

Study Record Updates

• Last Update Posted (Actual): June 18, 2021
• Last Update Submitted That Met QC Criteria: May 25, 2021
• Last Verified: May 1, 2021

More Information

Terms related to this study

• Keywords: Cardiovascular disease; Angina; Myocardial ischemia; Ranolazine; Exercise Treadmill Test
• Additional Relevant MeSH Terms: Cardiovascular Diseases; Vascular Diseases; Molecular Mechanisms of Pharmacological Action; Membrane Transport Modulators; Sodium Channel Blockers; Ranolazine
• Other Study ID Numbers: CPJMR0032105

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No