Non-ischemic Cardiomyopathy Clinical Trial
Official title:
Development of an Evidenced-Based Tool for Prediction of Sudden Death in Patients With Non-Ischemic Cardiomyopathy (NICM-Registry)
This study is an observational study to determine predictors of sudden cardiac death or appropriate ICD therapy in patients with non-ischemic cardiomyopathy. Patients will be followed for 36 months for the occurrence of sudden cardiac death
Non-ischemic cardiomyopathy (NICM) comprises almost one half of the congestive heart failure
(CHF) population NICM portends an increased risk for hospitalizations due to CHF as well as
death. This population is also at high risk for the occurrence of tachyarrhythmias and has a
high incidence of sudden cardiac death (SCD). The risk of SCD can be lowered by the placement
of an (intercardioverter defibrillator) ICD. The implantation of an ICD significantly reduces
the risk of SCD in patients with NICM and a left ventricular ejection fraction (LVEF) of 35
percent or less. However the implantation of an ICD has short term as well as long term risk
associated with it. Many patients receive an ICD who never go on to have appropriate therapy.
Current American College of Cardiology/American Heart Association (ACC/AHA) guidelines state
that "ICD therapy is recommended for primary prevention of SCD to reduce total mortality in
selected patients with nonischemic dilated cardiomyopathy (DCM) or ischemic heart disease at
least 40 days post-myocardial infarction(MI) with LVEF of 35% or less and New York Heart
Association (NYHA) class II or III symptoms on chronic guideline-directed medical
therapy(GDMT), who have reasonable expectation of meaningful survival for more than 1 year."
There is a need for new criteria for ICD placement in patients with NICM that are more
sensitive and specific than current guidelines.
Delayed enhancement imaging on cardiac magnetic resonance imaging (CMR) has become the gold
standard for myocardial scar/necrosis detection. The presence of late gadolinium enhancement
(LGE) on CMR which corresponds to myocardial scarring or fibrosis has been shown to be a
predictor of adverse outcomes in ischemic cardiomyopathy. There have been few studies
evaluating the significance of LGE in patients with NICM, however the results are promising.
The presence of LGE has been associated with the incidence of inducible tachycardia by
electrophysiology (EP) testing in patients with NICM. LGE has also been associated with an
increased risk of morbidity and mortality in a general NICM population.
The investigators plan to enroll patients with NICM with an EF ≤ 40% who have been referred
for CMR and follow them for the composite endpoint of sudden cardiac death or an appropriate
ICD therapy (Antitachycardic pacing or shock).
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