Prediction of ARrhythmic Events With Positron Emission Tomography II
| Status: | Recruiting |
|---|---|
| Conditions: | Cardiology, Cardiology, Cardiology, Cardiology |
| Therapuetic Areas: | Cardiology / Vascular Diseases |
| Healthy: | No |
| Age Range: | 18 - Any |
| Updated: | 11/23/2018 |
| Start Date: | April 8, 2018 |
| End Date: | December 31, 2023 |
| Contact: | John M Canty, MD |
| Email: | canty@buffalo.edu |
| Phone: | (716) 829-2663 |
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.
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.
Using current guidelines based primarily on ejection fraction (EF), only one-quarter of
patients receiving an implantable cardiac defibrillator (ICD) for the primary prevention of
sudden cardiac arrest (SCA) require appropriate ICD therapy within 5 years. The NIH-sponsored
PAREPET study (Prediction of ARrhythmic Events with Positron Emission Tomography,
ClinicalTrials.gov, NCT01400334) identified four independent risk factors that predict SCA or
ICD equivalent in patients with ischemic cardiomyopathy. Using retrospectively defined
cut-points, the absence of these risk factors identified 38% of the cohort with a very low
risk of SCA (<1% per year). This rate is actually lower than the 1.5-2% annual rate of SCA
among patients with coronary artery disease and mild left ventricular (LV) dysfunction, who
are not considered candidates for a primary prevention ICD. This proposal will prospectively
determine whether these risk factors can form the basis of a clinically applicable approach
to identify a subgroup of patients who are candidates for an ICD, but are at low enough risk
of SCA to have an ICD safely withheld. Our long-term goal is to develop better approaches to
identify patients with coronary artery disease who are most likely to benefit from prevention
of SCA with placement of an implantable defibrillator.
patients receiving an implantable cardiac defibrillator (ICD) for the primary prevention of
sudden cardiac arrest (SCA) require appropriate ICD therapy within 5 years. The NIH-sponsored
PAREPET study (Prediction of ARrhythmic Events with Positron Emission Tomography,
ClinicalTrials.gov, NCT01400334) identified four independent risk factors that predict SCA or
ICD equivalent in patients with ischemic cardiomyopathy. Using retrospectively defined
cut-points, the absence of these risk factors identified 38% of the cohort with a very low
risk of SCA (<1% per year). This rate is actually lower than the 1.5-2% annual rate of SCA
among patients with coronary artery disease and mild left ventricular (LV) dysfunction, who
are not considered candidates for a primary prevention ICD. This proposal will prospectively
determine whether these risk factors can form the basis of a clinically applicable approach
to identify a subgroup of patients who are candidates for an ICD, but are at low enough risk
of SCA to have an ICD safely withheld. Our long-term goal is to develop better approaches to
identify patients with coronary artery disease who are most likely to benefit from prevention
of SCA with placement of an implantable defibrillator.
Inclusion Criteria:
- Coronary artery disease (by cardiac catheterization or definite myocardial infarction)
- ICD implantation for the primary prevention of SCA
- Medical therapy including beta-blockers and angiotensin inhibition therapy
[angiotensin converting enzyme inhibitor (ACEI) or angiotensin receptor antagonist
(ARA)].
Exclusion Criteria:
- 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
We found this trial at
1
site
Buffalo, New York 14203
Phone: 716-888-4848
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