Please select the eligibility criteria that correspond to the clinical trial below.
Title: A Phase 4, Randomized, Double-Blind, Placebo-Controlled, Parallel Study of Ranolazine in Subjects With Chronic Stable Angina and Coronary Artery Disease With a History of Type 2 Diabetes Mellitus
Brief Summary: This study will evaluate the effect of ranolazine compared to placebo on the average weekly angina frequency in subjects with chronic stable angina and coronary artery disease (CAD) who have a history of type 2 diabetes mellitus (T2DM), and whether ranolazine can reduce the frequency of angina (chest pain) attacks, compared to a placebo. Subjects will be asked to record their daily angina episodes in a diary at the end of each study day. Ranolazine is approved for the treatment of chronic angina, and is not approved for the treatment of T2DM.


Options:
A: Inclusion Criteria:

* LVEF less than 45%
* Functional class III or IV angina
* At least 7% reversibility by Single Photon Emission Computed Tomography (SPECT) nuclear study
* there are additional inc. criteria

Exclusion Criteria:

* AGe \<18 or \>70 years of age
* Constant atrial fibrillation
* Left ventricular (LV) thrombus
* History of malignancy in the last 5 years
* LV wall thickness of \< 8 mm at the target site
* there are additional exclusion criteria
B: Inclusion Criteria:

* Written informed consent
* Males and females aged at least 18 years
* At least a 3-month history of chronic stable angina triggered by physical effort and relieved by rest and/or sublingual nitroglycerin
* CAD documented by one or more of the following:

  1. Angiographic evidence of ≥ 50% stenosis of one or more major coronary arteries
  2. History of myocardial infarction (MI) documented by positive myocardial muscle creatine kinase (CK-MB) enzymes, troponins, or electrocardiogram (ECG) changes
  3. Cardiac imaging study or exercise test diagnostic for CAD
* Treatment with up to 2 antianginal therapies at a stable dose for at least 2 weeks prior to the Qualifying Period.
* Documented history of T2DM
* Willing to maintain stable tobacco usage habits throughout the study
* Willing to maintain stable activity levels throughout the study
* Females of childbearing potential must agree to utilize highly effective contraception methods from Screening throughout the duration of study treatment and for 14 days following the last dose of study drug.

Exclusion Criteria:

* New York Heart Association (NYHA) Class III and IV
* Acute coronary syndrome in the prior 2 months or planned coronary revascularization during the study period
* Stroke or transient ischemic attack within 6 months prior to Screening
* QTc \> 500 milliseconds
* Uncontrolled hypertension (seated systolic blood pressure \> 180 mmHg or diastolic blood pressure \> 110 mmHg)
* Systolic blood pressure \< 100 mmHg
* Clinically significant hepatic impairment
* Prior treatment with ranolazine, or known hypersensitivity or intolerance to ranolazine
* Females who are breastfeeding
* Positive serum pregnancy test
* Participation in another investigational drug or device study within 1 month prior to Screening
* Current treatment with trimetazidine, ivabradine, or nicorandil. Subjects will need to discontinue these medications 2 weeks prior to the Qualifying Period.
* Current treatment with potent inhibitors of cytochrome (CYP)3A (eg, ketoconazole, itraconazole, clarithromycin, nefazodone, nelfinavir, ritonavir, indinavir, and saquinavir)
* Current treatment with CYP3A and P glycoprotein (Pgp) inducers (eg, rifampicin/rifampin, carbamazepine, and St. John's wort \[Hypericum perforatum\])
* Current treatment with CYP3A4 substrates with a narrow therapeutic range (eg, cyclosporine, tacrolimus, and sirolimus)
* Subjects taking simvastatin who cannot reduce the dose to 20 mg once daily or who cannot switch to another statin
* Current treatment with Class I or III antiarrhythmic medications
* History of illicit drug use or alcohol abuse within 1 year of Screening
* Any other conditions that, in the opinion of the investigator, are likely to prevent compliance with the study protocol or pose a safety concern if the subject participates in the study
C: Inclusion Criteria:

* Subject is ≥ 18 and \< 75 years old;
* Subject has Heart Failure, New York Heart Association (NYHA) class II or class III with LVEF \> 15% and ≤ 40% as assessed by transthoracic echocardiography;
* Subject has ischemic heart disease;
* Subject has an identifiable (by transthoracic echocardiography) area of transmural scar within the left ventricle;
* Subject is on optimal and stable medical therapy for more than 2 months;
* Subject is willing and able to undergo an ICD implantation, prior to receiving C-Cure™ or already has an ICD implanted;
* Subject agrees to comply with all follow-up evaluations;
* Subject has been informed of the nature of the clinical trial and agrees to its provision and has provided written informed consent.

Exclusion Criteria:

* Subject has been treated with cell-based therapy;
* Subject has myocardial revascularization by PCI or CABG within 2 months prior to enrolment;
* Subject has had an MI within 2 months prior to enrolment;
* Subject is planned for PCI, CABG or any cardiac surgery;
* Subject has received a biventricular pacemaker within 6 month prior to enrolment;
* Subject has moderate to severe aortic valve heart disease, aortic or mitral prosthetic valve;
* Subject has a significant mitral valve insufficiency (Effective Regurgitant Orifice (ERO) \> 0.2 cm²) with possibility of mitral valve surgery;
* Subject has left ventricular thrombus;
* Subject has LV aneurysma or is a candidate for surgical aneurysmectomy;
* Subject LV ventricular wall thickness is \< 5 mm in the target territory;
* Subject has proven high grade atrioventricular block or sustained ventricular tachyarrhythmias;
* Subject has an hemodynamically significant congenital heart disorder;
* Subject has clinical evidence for infection or active malignancy;
* Subject has known stable chronic kidney dysfunction with serum creatinine \> 2.5 mg/dL at two occasions during the screening period;
* Subject has experienced severe adverse reaction/allergies to contrast agents;
* Subject has atherosclerosis and/or tortuosity of the aorta, iliac or femoral arteries of a degree, that could impede or preclude the safe retrograde passage of the delivery catheter, in the judgment of the investigator;
* Subject is on chronic immunosuppressive transplant therapy;
* Subject had an autologous or allogenic bone marrow or peripheral stem cell transplant or prior solid organ transplantation;
* Subject has a multisystem disease;
* Subject has been tested positive for Human Immunodeficiency Virus (HIV 1 or HIV 2), Hepatitis B Virus (HBV), Hepatitis C (HCV) and/or syphilis;
* Women of child bearing potential;
* Subject has life expectancy \< 1 year from non heart failure related causes;
* Subject suffers from morbid obesity (Body Mass Index (BMI) \> 40);
* Subject has a recent history of alcohol or drug abuse;
* Subject has any other surgical or medical condition that, in the judgment of the investigator might warrant exclusion or be contraindicated for safety reasons;
* Subject is currently participating in another trial.
D: Inclusion Criteria:

* Established dg. of dilated CMP (defined according to ESC position statement - absence of any stenotic lesions on coronary angiography, no congenital heart disease, no primary valve disease on echocardiography, and no history of hypertension or alcohol abuse1)
* left ventricular ejection fraction \< 30%
* NYHA functional class III or IV for at least 3 months before referral
* Optimal medical management for at least 6 months

Exclusion Criteria:

* Left ventricular aneurysm or thrombus
* Hematologic disease
* Multiorgan failure
* Active malignancy

Answer: B