Impact of Ranalozine on Coronary Microcirculatory Resistance- A Prospective Single Center Study to Evaluate the Effect of Ranalozine in Microcirculatory Resistance (MICRO Study)
Rnalozine
Arterial Occlusive Diseases+9
+ Arteriosclerosis
+ Cardiovascular Diseases
Treatment Study
Summary
Study start date: May 1, 2012
Actual date on which the first participant was enrolled.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.
Protocol
This section provides details of the study plan, including how the study is designed and what the study is measuring.7 patients to be enrolled
Total number of participants that the clinical trial aims to recruit.Treatment Study
Eligibility
Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.Any sex
Biological sex of participants that are eligible to enroll.Over 18 Years
Range of ages for which participants are eligible to join.Healthy volunteers not allowed
If individuals who are healthy and do not have the condition being studied can participate.Conditions
Pathology
Criteria
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
Study Plan
Find out more about all the medication administered in this study, their detailed description and what they involve.One single intervention group is designated in this study
This study does not include a placebo group
Treatment Groups
Group I
ExperimentalStudy Objectives
Primary Objectives
Study Centers
These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.This study has 1 location
University of New Mexico Health Science Center
Albuquerque, United StatesOpen University of New Mexico Health Science Center in Google Maps