Prediction of ARrhythmic Events With Positron Emission Tomography (PAREPET)
|ClinicalTrials.gov Identifier: NCT01400334|
Recruitment Status : Completed
First Posted : July 22, 2011
Last Update Posted : December 9, 2015
|Condition or disease||Intervention/treatment|
|Ischemic Cardiomyopathy Hibernating Myocardium Nerve; Disorder, Sympathetic||Radiation: Positron Emission Tomography|
|Study Type :||Observational|
|Actual Enrollment :||257 participants|
|Official Title:||Hibernating Myocardium and Sudden Cardiac Death|
|Study Start Date :||July 2004|
|Primary Completion Date :||December 2012|
|Study Completion Date :||December 2012|
Subjects with ischemic cardiomyopathy [pre-enrollment left ventricular ejection fraction ≤0.35, with coronary artery disease documented by cardiac catheterization, a history of definite myocardial infarction, or reversible ischemia on nuclear imaging] who are considered eligible to receive an implantable cardiac defibrillator for the primary prevention of sudden cardiac death.
Radiation: Positron Emission Tomography
Quantification of cardiac function using positron emission tomography and: a)11C-meta-hydroxyephedrine [HED, 20 mCi (740 MBq)] to quantify sympathetic nerve function, b) 13N-ammonia [NH3, 20 mCi (740 MBq)] for regional perfusion, and c) 18F-2-deoxyglucose [FDG; 6.5 mCi (241 MBq)] administered during a hyperinsulinemic-euglycemic clamp to assess viability.
- Sudden Cardiac Death [ Time Frame: every 3 months ]Adjudicated sudden cardiac death and implantable cardiac defibrillator therapy for fast ventricular tachycardia (>240 bpm) or ventricular fibrillation.
- Cardiac Death [ Time Frame: every 3 months ]Sudden cardiac death and adjudicated non-sudden cardiac death
Biospecimen Retention: Samples Without DNA
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01400334
|United States, New York|
|Buffalo, New York, United States, 14214|
|Principal Investigator:||John M Canty, MD||State University of New York at Buffalo|
|Principal Investigator:||James A Fallavollita, MD||State University of New York at Buffalo|