Prediction of ARrhythmic Events With Positron Emission Tomography II
Running, not enrolling
Conditions studied: Sudden Cardiac Arrest, Ischemic Cardiomyopathy, Congestive Heart Failure
In brief
Sudden cardiac death continues to be a major contributor to mortality in patients with ischemic cardiomyopathy. While implantable defibrillators can prevent death from ventricular arrhythmias, our current approach to identify patients at highest risk primarily rests on demonstrating a reduction in left ventricular ejection fraction less than 35%. The purpose of this observational cohort study is to prospectively test whether this can be enhanced by quantifying the amount of sympathetic denervation, left ventricular end-diastolic volume or brain natriuretic peptide levels.
Key facts
- Study ID
- NCT03493516
- Run by
- State University of New York at Buffalo
- People needed
- 302
- Starts
- 2018-04-08
- Expected to finish
- 2026-12-31
- Last updated by the study team
- 2026-03-06
Who can join
Age: 18 and older. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- Coronary artery disease (by cardiac catheterization or definite myocardial infarction)
- ICD implantation for the primary prevention of SCA
- Primary prevention patients with a Biventricular ICD
- Eligible immediately when this is placed to prevent dysynchrony related to intermittent RV pacing and the native QRS duration is ≤ 130 msec in the absence of pacing.
- Eligible 6 months after implantation when the native QRS duration prior to implant is >130 msec or there is persistent RV pacing.
- Optimal medical therapy for heart failure.
You may not qualify if…
- Plans for coronary revascularization (due to the independent impact on SCA)
- Contraindication for PET (i.e. claustrophobia, pregnancy, physical limitation)
- Tricyclic antidepressant use (inhibits norepinephrine and LMI1195 uptake)
- Comorbidities limiting life expectancy <2yr.
- Age <18 years or inability to provide informed consent
- Primary prevention ICD/BiV recipients who have received an appropriate ICD shock prior to enrollment
Where it is running
- University at Buffalo Clinical and Translational Research Center — Buffalo, New York, United States
Full record on ClinicalTrials.gov
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