Evaluation of Exercise Treadmill test indices in patients with cardiovascular disease

Study Status

Open to Enrollment

Study Description

The purpose of this study is to evaluate the use of a novel exercise treadmill test (ETT) electrocardiogram (ECG) indices as biomarkers in the assessment of Atherosclerotic Coronary Vascular Disease (ASCVD) (a Coronary Artery Disease or CAD) and to determine how the indices are affected by fatty acid inhibition anti-ischemic treatment in the absence and presence of a drug called Ranolazine. 

If  you decide to participate in this trial, and you meet the requirements of the exercise treadmill tests, you will be given ranolazine (brand name Ranexa) a medicine which has been approved by the U.S. Food and Drug Administration (FDA) for the treatment of people with your medical condition.

This is a single center study in subjects with stable atherosclerotic coronary vascular disease (ASCVD). The study will evaluate the use of a novel ETT ECG indices as biomarkers in the assessment of ASCVD. It seeks to determine the impact of heart rate adjustment indices of ST segment depression in order to enable the use of these indices in the future, in the absence and presence of a drug called Ranolazine (Ranexa). 

Ranolazine (Ranexa) is an FDA approved drug commonly used to manage patients with angina and underlying myocardial ischemia due to ASCVD. One important way that ranolazine decreases ischemia is through its ability to partially inhibit fatty acid oxidation. Ranolazine thereby shifts the balance of myocardial metabolism away from fatty acids toward oxidation of carbohydrates and increases the efficiency of how the myocardium consumes oxygen as it does its work to contract. Based on the decreased ischemia resulting from improved myocardial efficiency, ranolazine has been shown to decrease chest pain and improve exercise performance (duration and time) in patients with ASCVD. Ranolazine (Ranexa), an approved FDA drug, commonly used to manage patients with chronic myocardial ischemia due to ASCVD. Ranolazine has also been shown to decrease chest pain and improve exercise performance (duration and time) in patients with ASCVD. 

We will conduct a series of screening and baseline tests prior to the administration of ranolazine. In addition, subjects will go through a series of exercise treadmill tests before and after the administration of ranolazine that will allow us to record the subjects vital signs ( resting blood pressure and heart rate) and ECG tracings. By examining the variability of heart rate adjusted indices of ST segment depression, we will be able to determine how they may be employed as biomarkers of pharmacodynamics and efficacy in future studies.

Disease Status and/or Stage

Stable Coronary Artery Disease

Sponsor

Novartis

Key Eligibility

  • History of stable coronary artery disease as defined by the presence of greater or equal to one of the following:
    • Stable angina (chest pain) that is medically treated (minimum 3 month history)
    • History of exercise treadmill test and/or other imaging suggesting ischemic coronary disease which has required ongoing medical treatment
    • History of coronary angiography with or without coronary intervention/PTCA with greater or equal to 1 vessel with greater or equal to 50% stenosis at the end of the procedure (or after any intervention)

Principal Investigator

Peter Okin, MD

Contact

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Contact Us

For general inquiries, or if you need assistance finding a study, please contact:

Robert Hagerty
Subject Recruitment Manager
Tel: (646) 962-9340
[email protected]

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