Impact of Ranolazine on Coronary Microcirculatory Resistance

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.

Study Overview

• Status: Completed
• Conditions: Ischemia; Coronary Artery Disease; Myocardial Disease; Coronary Microcirculation
• Intervention / Treatment: Drug: Rnalozine

• Study Type: Interventional
• Enrollment (Actual): 7
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • New Mexico
    • Albuquerque, New Mexico, United States, 87131
      • University of New Mexico Health Science Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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

How is the study designed?

Design Details

• Primary Purpose: Treatment
• 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: Ranalozine; 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; . 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.; Other Names: Ranexa; Ranalozine

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Absolute change in SAQ and DASI scores before and after Ranolazine therapy.	Absolute change in SAQ and DASI scores before and after Ranolazine therapy. Mean change between the groups will be analyzed using a paired t test.	4 weeks
Compare relative change in IMR among patients with and without symptomatic improvement in angina burden based on SAQ and DASI scores.	Compare relative change in IMR among patients with and without symptomatic improvement in angina burden based on SAQ and DASI scores.	4 weeks

Collaborators and Investigators

• Sponsor: University of New Mexico
• Collaborators: Gilead Sciences
• Investigators: Principal Investigator: Bina Ahmed, MD, Assistant Professor, IM Div Cardiology

Study record dates

Study Major Dates

• Study Start (Actual): May 1, 2012
• Primary Completion (Actual): March 1, 2016
• Study Completion (Actual): March 1, 2016

Study Registration Dates

• First Submitted: March 19, 2013
• First Submitted That Met QC Criteria: March 19, 2013
• First Posted (Estimated): March 21, 2013

Study Record Updates

• Last Update Posted (Actual): December 26, 2023
• Last Update Submitted That Met QC Criteria: December 7, 2023
• Last Verified: December 1, 2023

More Information

Terms related to this study

• Keywords: coronary artery disease; ischemia; coronary microcirculation; myocardial disease
• Additional Relevant MeSH Terms: Pathologic Processes; Heart Diseases; Cardiovascular Diseases; Vascular Diseases; Arteriosclerosis; Arterial Occlusive Diseases; Coronary Artery Disease; Myocardial Ischemia; Coronary Disease; Ischemia; Cardiomyopathies
• Other Study ID Numbers: 12-069 MICRO Study