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Impact of Ranolazine on Coronary Microcirculatory Resistance

Primary Purpose

Coronary Microcirculation, Coronary Artery Disease, Myocardial Disease

Status
Unknown status
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Rnalozine
Sponsored by
University of New Mexico
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Coronary Microcirculation focused on measuring coronary microcirculation, coronary artery disease, myocardial disease, ischemia

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • University of New Mexico Health Science CenterRecruiting

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Ranalozine

Arm Description

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.

Outcomes

Primary Outcome Measures

Relative change in IMR before and after Ranolazine therapy.
Relative change in IMR before and after Ranolazine therapy. Mean change between the groups will be analyzed using a paired t test.

Secondary Outcome Measures

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.
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.

Full Information

First Posted
March 19, 2013
Last Updated
June 1, 2015
Sponsor
University of New Mexico
Collaborators
Gilead Sciences
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1. Study Identification

Unique Protocol Identification Number
NCT01815957
Brief Title
Impact of Ranolazine on Coronary Microcirculatory Resistance
Official Title
Impact of Ranalozine on Coronary Microcirculatory Resistance- A Prospective Single Center Study to Evaluate the Effect of Ranalozine in Microcirculatory Resistance (MICRO Study)
Study Type
Interventional

2. Study Status

Record Verification Date
June 2015
Overall Recruitment Status
Unknown status
Study Start Date
May 2012 (undefined)
Primary Completion Date
June 2016 (Anticipated)
Study Completion Date
undefined (undefined)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of New Mexico
Collaborators
Gilead Sciences

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Coronary Microcirculation, Coronary Artery Disease, Myocardial Disease, Ischemia
Keywords
coronary microcirculation, coronary artery disease, myocardial disease, ischemia

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
20 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Ranalozine
Arm Type
Experimental
Arm Description
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.
Intervention Type
Drug
Intervention Name(s)
Rnalozine
Other Intervention Name(s)
Ranexa, Ranalozine
Intervention Description
. 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.
Primary Outcome Measure Information:
Title
Relative change in IMR before and after Ranolazine therapy.
Description
Relative change in IMR before and after Ranolazine therapy. Mean change between the groups will be analyzed using a paired t test.
Time Frame
4 weeks
Secondary Outcome Measure Information:
Title
Absolute change in SAQ and DASI scores before and after Ranolazine therapy.
Description
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.
Time Frame
4 weeks
Title
Compare relative change in IMR among patients with and without symptomatic improvement in angina burden based on SAQ and DASI scores.
Description
Compare relative change in IMR among patients with and without symptomatic improvement in angina burden based on SAQ and DASI scores.
Time Frame
4 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Bina Ahmed, MD
Phone
505-272-2273
Email
BAhmed@Salud.unm.edu
First Name & Middle Initial & Last Name or Official Title & Degree
Judith Mondragon, RN
Phone
505272-9223
Email
jmondragon@salud.unm.edu
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Bina Ahmed, MD
Organizational Affiliation
Assistant Professor, IM Div Cardiology
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of New Mexico Health Science Center
City
Albuquerque
State/Province
New Mexico
ZIP/Postal Code
87131
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Bina Ahmed, MD
Phone
505-272-2273
Email
BAhmed@Salud.unm.edu
First Name & Middle Initial & Last Name & Degree
Lyra Salandre, BA
Phone
505-272-9898
Email
LSalandre@Salud.unm.edu
First Name & Middle Initial & Last Name & Degree
Bina Ahmed, MD

12. IPD Sharing Statement

Learn more about this trial

Impact of Ranolazine on Coronary Microcirculatory Resistance

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