Impact of Ranolazine on Coronary Microcirculatory Resistance



Status:Recruiting
Conditions:Peripheral Vascular Disease, Cardiology
Therapuetic Areas:Cardiology / Vascular Diseases
Healthy:No
Age Range:18 - Any
Updated:4/2/2016
Start Date:May 2012
Contact:Bina Ahmed, MD
Email:BAhmed@Salud.unm.edu
Phone:505-272-2273

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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)

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.


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
We found this trial at
1
site
Albuquerque, New Mexico 87131
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mi
from
Albuquerque, NM
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