Please select the eligibility criteria that correspond to the clinical trial below.
Title: PRE-DETERMINE: Biologic Markers and MRI SCD Cohort Study
Brief Summary: This is a prospective, multi-center cohort study of patients with a history of coronary artery disease (CAD) and documentation of either a prior myocardial infarction (MI) or mild to moderate left ventricular dysfunction (LVEF 35-50%). The primary objective of this study is to determine whether biologic markers and ECGs can be utilized to advance SCD risk prediction in patients with CHD and LVEF\>30-35%. The overarching goal of the study is to identify a series of markers that alone or in combination specifically predict risk of arrhythmic death as compared to other causes of mortality among this at risk population of coronary heart disease (CHD) patients with preserved left ventricular ejection fraction (LVEF\> 30-35%). If biologic or ECG markers are identified that can specifically predict risk of ventricular arrhythmias, then these markers may serve as relatively inexpensive methods to identify those at risk. The public health impact of identifying markers could be quite substantial, leading to more efficient utilization of ICDs and advances in our understanding of mechanisms underlying SCD.


Options:
A: Inclusion Criteria:

* ≥ 18 years of age at the time of screening.
* Documented non-ischemic HF with an LVEF ≤ 35%.
* NYHA class II-III. If patients are planned for an implantation with a biventricular pacemaker NYHA class IV patients will be accepted for the trial.
* Before any study-specific procedure, including assessments for screening, the appropriate written informed consent must be obtained (see section 12.1).
* NT-proBNP above 200 pg/ml (see appendix D).

Exclusion Criteria:

To be eligible for this study, subjects must not meet any of the following criteria:

* Uncorrected congenital heart disease or valve obstruction, obstructive cardiomyopathy, active myocarditis, constrictive pericarditis, untreated hypothyroidism or hyperthyroidism, adrenal insufficiency, active vasculitis due to collagen vascular disease.
* On the urgent waiting list for a heart transplant (UNOS category 1A or 1B, or equivalent). Patients on the non-urgent waiting list for a heart transplant (UNOS category 2 or 7, or equivalent) are eligible for inclusion in the study.
* Recipient of any major organ transplant (eg, lung, liver, heart or kidney).
* Receiving or has received cytotoxic or cytostatic chemotherapy and/or radiation therapy for treatment of a malignancy within 6 month before randomisation or clinical evidence of current malignancy, with the following exceptions: basal or squamous cell carcinoma of the skin, cervical intraepithelial neoplasia, prostate cancer (if stable localized disease, with a life expectancy of \> 2.5 years in the opinion of the investigator).
* Known to be human immunodeficiency virus positive with an expected survival of less than 5 years due to HIV.
* Renal failure treated with dialysis.
* Recent (within 3 months) history of alcohol or illicit drug abuse disorder, based on self-report
* Any condition (eg, psychiatric illness) or situation that, in the investigator's opinion, could put the subject at significant risk, confound the study results, or interfere significantly with the subject's participation in the study.
* Unwilling to participate.
B: Inclusion Criteria:

* Subjects with previously symptomatic heart failure but no current symptoms (New York Heart Association (NYHA) Class I, Stage C) or subjects with mild heart failure that only sometimes interferes with daily activities (NYHA Class II)
* Subjects with a QRS of 120 ms or more (The QRS interval is a measurement of how the electrical signal involved in a heart beat travels/conducts through the ventricles. A wide QRS (120 ms or more) suggests that there is a conduction problem (or block) in the ventricles).
* Subjects with a left ventricular ejection fraction less than or equal to 40%. (The left ventricular ejection fraction (LVEF) is a measurement of how well the left ventricle pumps blood out to the rest of the body. The higher the LVEF the more blood the ventricle is pumping.)
* Subjects with a left ventricular end diastolic dimension (LVEDD) greater than or equal to 55. (The left ventricular end diastolic dimension (LVEDD) is a measurement of heart size taken during an echocardiogram that is one indication of the health of the left ventricle.)

Exclusion Criteria:

* Subjects who are pacemaker dependent (heart would not beat without the help of an implanted device to pace it).
* Subjects with heart failure that severely limits daily activities (NYHA Class III) or subjects with severe heart failure with symptoms while resting (NYHA Class IV).
* Subjects hospitalized due to heart failure within past 3 months.
C: Inclusion Criteria:

1. Evidence of Coronary Artery Disease (CAD) a or documented prior Myocardial Infarction.
2. LVEF \>35% by any current standard evaluation technique (e.g.,) echocardiogram, MUGA, angiography). 2.1. Patients who have an LVEF between 30-35% and NYHA Class I heart failure who do not have history of ventricular tachyarrhythmias,or inducible ventricular tachycardia during electrophysiological (EP) testing can be enrolled.
3. If documented prior MI is not present, evidence of mild-moderate systolic Left Ventricular Dysfunction with an EF \>35- ≤50% as measured by any current standard screening technique (e.g.,echocardiogram, MUGA, angiography) must be present.
4. Patients aged 18 years or above

   1. CAD will be defined as evidence of one of the following two (2) criteria:

      * Significant stenosis of a major epicardial vessel (\>50% proximal or 70% distal) by coronary angiography
      * Prior revascularization (percutaneous coronary intervention or coronary artery bypass surgery)
   2. MI can be documented in the following ways:

      * From the MI hospitalization: Detection of a rise and fall of cardiac biomarkers \> 99th percentile of lab (e.g., CPK elevation or Troponin at least \> two times the upper limit of normal) together with myocardial ischemia with at least one of the following:

        * Symptoms of Ischemia
        * ECG changes indicative of new ischemia (new ST-T changes or new LBBB)
        * Development of pathological Q waves
        * Imaging evidence of new loss of viable myocardium or new regional wall motion abnormality
      * If no report from the MI hospitalization is available, prior MI can be met by either of the following:

        * Development of pathological Q waves
        * Imaging evidence of a region of loss of viable myocardium that is thinned and fails to contract, in the absence of a non-ischaemic cause

Exclusion Criteria:

1. History of cardiac arrest or spontaneous or inducible sustained VT (15 beats or more at a rate of 120 BPM or greater - the occurrence of cardiac arrest or spontaneous VT in the setting of an acute MI is not considered an exclusion).
2. Unexplained syncope
3. Current or planned implantable cardiac defibrillator (ICD)
4. Any condition other than cardiac disease that, in the investigator's judgment, would seriously limit life expectancy (poor survival)
5. Metastatic cancer
6. Marked valvular heart disease requiring surgical intervention
7. Current or planned cardiac, renal or liver transplant
8. Current alcohol or drug abuse
9. Unwilling or unable to provide informed consent
10. LVEF \<35% with Class II-IV CHF or LVEF \<30%
11. Participation in a clinical trial where the active treatment arm is testing an agent and/or intervention with known antiarrhythmic properties
D: Inclusion Criteria:

* Moderate or severe heart failure, defined as symptomatic heart failure for at least six months with NYHA Class III or IV symptoms at the time of enrollment, AND at least one of the following events in the previous 12 months:
* Hospitalization for heart failure management
* Outpatient visit in which intravenous (IV) inotropes or vasoactive infusion were administered continuously for at least 4 hours
* Emergency room visit of at least twelve hours duration in which IV heart failure medications were administered (including diuretics)
* QRS \> or = 120 ms and PR interval \> 150 ms from any two leads of a 12-lead ECG
* Left ventricular ejection fraction \< or = 35%
* Left ventricular end diastolic dimension \> or = 60 mm (required only if LVEF measured by echo) or \> 3.0 cm/m2 \[The cm/m2 is calculated by LVEDD (in cm) divided by BSA (body surface area)\].
* Age \> or = 18 years
* Optimal pharmacologic therapy for heart failure

Exclusion Criteria:

* Unable or unwilling to undergo device implant and follow-up testing
* Meet the general indications for an implantable cardioverter defibrillator
* Meet the general indications for antibradycardia pacing
* Expected to receive a heart transplant in the next six months
* Chronic, medically refractory atrial tachyarrhythmias
* Unexplained syncope
* Myocardial infarction within 60 days of randomization
* History of non-compliance with oral heart failure therapy
* Progressive or unstable angina
* Uncontrolled blood pressure: Systolic BP \> 160 mm Hg or \< 85 mm Hg or diastolic BP \> 90 mm Hg
* Patients with a hypersensitivity to a 0.7 mg nominal dose of dexamethasone acetate
* Surgically uncorrected primary valvular heart disease
* Coronary artery disease (CAD) in which surgical or percutaneous correction is recent (within 60 days of randomization)
* Women who are pregnant or not using medically acceptable birth control
* Hypertrophic obstructive cardiomyopathy
* Amyloid disease
* Hospitalization for heart failure or IV inotropic or vasoactive therapy in excess of 4 hours in the 30 days prior to enrollment
* Have a tricuspid prosthesis
* Involved in any other investigational studies
* Life expectancy \< 6 months due to any other medical conditions

Answer: C