Development of an Evidenced-Based Tool for Prediction of Sudden Death in Patients With Non-Ischemic Cardiomyopathy (NICMR)
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|ClinicalTrials.gov Identifier: NCT02657967|
Recruitment Status : Recruiting
First Posted : January 18, 2016
Last Update Posted : June 14, 2019
|Condition or disease|
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).
|Study Type :||Observational [Patient Registry]|
|Estimated Enrollment :||1950 participants|
|Target Follow-Up Duration:||3 Years|
|Official Title:||Development of an Evidenced-Based Tool for Prediction of Sudden Death in Patients With Non-Ischemic Cardiomyopathy (NICM-Registry)|
|Study Start Date :||May 2015|
|Estimated Primary Completion Date :||December 2019|
|Estimated Study Completion Date :||December 2019|
- Sudden Cardiac Death or Appropriate ICD Shock Therapy or Anti-tachycardia Pacing or Resuscitated Sudden Cardiac Death [ Time Frame: 3 years ]
Sudden cardiac death is defined as patients who die suddenly and unexpectedly within 1 hour of cardiac symptoms in the absence of progressive cardiac deterioration, die unexpectedly in bed during sleep and/or die unexpectedly within 24 hours after last being seen alive.
Appropriate ICD therapy is defined as Shock Therapy or Antitachycardia Pacing.
- All cause death [ Time Frame: 3 years ]
Biospecimen Retention: Samples With DNA
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02657967
|Contact: Juan Gaztanaga, MDfirstname.lastname@example.org|
|United States, New York|
|Montefiore Medical Center||Recruiting|
|Bronx, New York, United States, 10467|
|Contact: Mario Garcia, M.D. 718-920-4172 email@example.com|
|Contact: Daniele Massera, M.D. 347-856-7382 DMASSERA@montefiore.org|
|NYU Winthrop Hospital||Recruiting|
|Mineola, New York, United States, 11501|
|Contact: Juan Gaztanaga, MD 516-663-4481 firstname.lastname@example.org|
|Contact: Wendy Drewes, RN 516-663-2929 email@example.com|
|University Health Network Toronto General Hospital||Recruiting|
|Toronto, Ontario, Canada, M5G 2C4|
|Contact: Heahter Ross, M.D. 416-340-4134 firstname.lastname@example.org|
|Contact: Natalia Nugaeva 416-340-4800 ext 3403 email@example.com|
|Principal Investigator:||Juan Gaztanaga, MD||NYU Langone Winthrop University Hospital|