Prediction of ARrhythmic Events With Positron Emission Tomography II

  • STATUS
    Recruiting
  • End date
    Dec 31, 2023
  • participants needed
    302
  • sponsor
    State University of New York at Buffalo
Updated on 23 January 2021
coronary artery disease
artery disease
medical therapy
ejection fraction
enzyme inhibitors
myocardial infarction
infarct
beta blockers
nesiritide
b-type natriuretic peptide
ace inhibitor
natriuretic peptide
cardiomyopathy
angiotensin
brain natriuretic peptide
cardiac death
primary prevention
beta-adrenergic blocking agents
sympathetic denervation
sudden cardiac death
angiotensin converting enzyme

Summary

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.

Description

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.

Details
Condition Sudden Cardiac Death, Heart failure, Heart disease, Ischemic Cardiomyopathy, Congestive Heart Failure, Cardiac Disease, sudden cardiac arrest, congestive heart disease
Treatment PET scan quantifying sympathetic denervation using [18F]-LMI1195
Clinical Study IdentifierNCT03493516
SponsorState University of New York at Buffalo
Last Modified on23 January 2021

Eligibility

Yes No Not Sure

Inclusion Criteria

Is your age greater than or equal to 18 yrs?
Gender: Male or Female
Do you have any of these conditions: Heart failure or Sudden Cardiac Death or Congestive Heart Failure or Cardiac Disease or Heart disease or Ischemic Cardiomyopathy?
Do you have any of these conditions: Sudden Cardiac Death or sudden cardiac arrest or Congestive Heart Failure or Heart failure or congestive heart disease or Ischemic Cardiomyopathy or H...?
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
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