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Cardiovascular Medicine - Active Clinical Trials
PRE-DETERMINE


Primary Investigator: Greg Flaker, MD

Study Coordinator: Sharon Clasby, LPN

Status: Active - open to enrollment

Study Title: Biologic markers and sudden cardiac death study

Primary Study Objectives
1.
To determine if biomarkers of inflammation, membrane stabilization, fibrosis, and myocardial dysfunction predict risk of ventricular arrhythmic events among patients with coronary artery disease (CAD) who do not have severe systolic dysfunction.
2.
To determine if sequence variants in genes coding for cardiac ion channels, structural protein inflammatory mediators, and adrenergic signaling receptors are associated with an increased risk of ventricular arrhythmic events among patients with CAD who do not have severe systolic dysfunction.
3.
To develop clinically useful predictive models based on these novel and conventional risk factors that predict risk of arrhythmic mortality as opposed to other causes of cardiac mortality in this at risk population.

Inclusion Criteria
1. Evidence of CAD.
2. LVEF >35% by any current standard evaluation technique (e.g., echocardiogram, MUGA,angiography).
    - Patients who have an EF 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. Evidence of prior myocardial Infarction (MI) defined by either:
    a. Clinical history of prior myocardial infarction 
        OR
    b. Mild-moderate systolic LV dysfunction with an EF >35 to -/<50.
   
c. CAD will be defined as evidence of one of the following three (3) criteria:
        - Prior myocardial infarction. 
        - 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).
   
d. MI is defined as the presence of two (2) of the following three (3) criteria:
       
- Symptoms consistent with myocardial infarction (i.e., chest pain, shortness of breath).   
        - Q-waves on electrocardiogram.
        - Elevated cardiac enzymes (CPK elevation > two times or troponin elevation > three times the upper limit of normal for the lab).
4. Patients aged 18 years or older.

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).*
•2.    Unexplained syncope.
•3.    Current or planned implanted permanent pacemaker and/or pacemaker/ICD lead.
•4.    Any condition other than cardiac disease that, in the investigator's judgment, would seriously limit life expectancy (poor six-month survival).
•5.    Marked valvular heart disease requiring surgical intervention.
•6.    Current or planned cardiac, renal or liver transplant.
•7.    Current alcohol or drug abuse.
•8.    Unwilling or unable to provide informed consent.
•9.    LVEF <35% with Class II-III CHF or LVEF <30%.

*The occurrence of cardiac arrest or spontaneous VT in the setting of an acute MI is not considered an exclusion.

Actions:
1.    Determine if patient fits major study criteria.
2.    Determine if patient is interested in joining a clinical trial.
3.    Call Sharon Clasby (beeper: 573-815-1268) and/or on-call research nurse (on-call beeper 573-499-8084) or Dr. Flaker to complete screening of subject.




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