Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-24 @ 6:43 PM
Ignite Modification Date:
2025-12-24 @ 6:43 PM
NCT ID:
NCT01815957
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
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT01815957
Study Brief:
Protocol Section:
NCT01815957