Impact of Ranolazine on Coronary Microcirculatory Resistance

Study Overview
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Brief Summary
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This study is being done to determine if Ranolazine treatment improves coronary microcirculation function among patients with coronary microcirculation dysfunction. We are also looking to learn if symptomatic improvement of chest pain during treatment with Ranalozine is related to improved coronary microcirculation function.

Official Title
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Impact of Ranalozine on Coronary Microcirculatory Resistance- A Prospective Single Center Study to Evaluate the Effect of Ranalozine in Microcirculatory Resistance (MICRO Study)

Conditions
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Coronary Microcirculation, Coronary Artery Disease, Myocardial Disease, Ischemia

Intervention / Treatment
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* Drug: Rnalozine


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: - Patients with subjective symptoms of ischemia without flow limiting angiographic CAD (<50% epicardial coronary stenosis) and abnormal IMR (>20 U). Definition of ischemia (any one): chest pain with dynamic ischemic ECG changes (t wave inversions or > 1 mm ST depressions Exercise treadmill testing induced chest pain with ≥1 mm of downsloping or flat ST segment depression during exercise or recovery; ≥2 mm of ischemic ST depression at a low workload (stage 2 or less or ≤130 beats/min); early onset (stage 1) or prolonged duration (>5 min) of ST depression; multiple leads (>5) with ST depression Nuclear stress perfusion defect > 10% Stress echocardiogram with stress induced wall motion abnormality Exclusion Criteria: - Age < 18 yrs Flow Limiting epicardial CAD >50% Life expectancy < 6 months Recent (<1 week) myocardial infarction or positive biomarkers Severe aortic stenosis Contraindications to IMR testing including inability to utilize antithrombotic therapy and/or intravenous adenosine Contraindications to Ranolazine therapy: Patients with known hepatic insufficiency, prolonged QT or renal failure (GFR < 60) use of drugs that inhibit CYP3A such as diltiazem, verapamil, ketoconazole, macrolides and HIV protease inhibitors Pregnancy, breastfeeding Patients taking drugs which prolong QT interval

Ages Eligible for Study
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Minimum Age: 18 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: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Ranalozine<br>After enrollment in the study, participants will initiate Ranolazine for 4 weeks. The participant's usual anti-anginal medication regimen will be continued unchanged throughout study duration. Patients will receive Ranolazine 500 mg orally twice daily for 1 week, and the dose will be increased to 1,000 mg twice daily for an additional 3 weeks if tolerated. | Drug: Rnalozine<br>* . After enrollment in the study, participants will initiate Ranolazine for 4 weeks. The participant's usual anti-anginal medication regimen will be continued unchanged throughout study duration. Patients will receive Ranolazine 500 mg orally twice daily for 1 week, and the dose will be increased to 1,000 mg twice daily for an additional 3 weeks if tolerated.<br>* Other names: Ranalozine;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of Participants Assessed for Relative Change in the Index of Microcirculatory Resistance Before and After Ranolazine Therapy |  | 4 weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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ischemia, coronary microcirculation, coronary artery disease, myocardial disease