186403 PRE DETERMINE Cohort Study

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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.

This research study is led by Dr. Hany Aziz.

Contact: Annette Scarnici, RN, CCRC, 413-794-9076

Participation Details:

Start Date: June 01, 2007

IRB Number: 186403

Condition/Disease: Heart

Location: Baystate Medical Center, 759 Chestnut St, Springfield, MA


Ages Eligible for Study: 18 Years and older (Adult, Older Adult)
Sexes Eligible for Study: All
Accepts Healthy Volunteers: No
Sampling Method: Probability Sample

Inclusion Criteria:

  • Evidence of Coronary Artery Disease (CAD) a or documented prior Myocardial Infarction.
  • Patients aged 18 years or above

Exclusion Criteria:

  • 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).
  • Current or planned implantable cardiac defibrillator (ICD)
  • Any condition other than cardiac disease that, in the investigator's judgment, would seriously limit life expectancy (poor survival)
  • Metastatic cancer

Current Trial Type: Observational

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