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NCT03493516Active, not recruiting

Prediction of ARrhythmic Events With Positron Emission Tomography II

Source: ClinicalTrials.gov · Last updated 6 Mar 2026

Brief summary (registry, in English)

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.

Status (registry)
Active, not recruiting
Study type
Observational
Enrollment
302 (estimated)
First submitted
26 Mar 2018
Start date
8 Apr 2018
Primary completion date
31 Dec 2026
Lead sponsor
State University of New York at Buffalo
NCT number
NCT03493516

What you commit to

  • Study type: Observational
  • Planned participants: 302
  • From 8 Apr 2018 to the primary completion date, 31 Dec 2026
  • 1 site in 1 country
  • Visits and tests: ask the trial team, the registry does not list them

Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.

Who cannot take part

Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.

Prior treatment

  • Primary prevention ICD/BiV recipients who have received an appropriate ICD shock prior to enrollment

Age

  • Age \<18 years or inability to provide informed consent

Other

  • 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.

Who the study is looking for

  • 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.

Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers

Full criteria on ClinicalTrials.gov

Sites (1)

Sites in registry order. Pick your city on the disease page to sort them by distance.

SiteCityCountrySite status
University at Buffalo Clinical and Translational Research Center
Coordinator of this site? Confirm its status
BuffaloUnited StatesUnknown status

This page is information, not medical advice. Discuss any trial with your doctor.