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临床试验/NCT03493516
NCT03493516进行中(未招募)不适用

Prediction of ARrhythmic Events With Positron Emission Tomography II

State University of New York at Buffalo1 个研究点 分布在 1 个国家目标入组 302 人开始时间: 2018年4月8日最近更新:
适应症

试验速览

阶段
不适用
状态
进行中(未招募)
入组人数
302
试验地点
1
主要终点
Sudden Cardiac Arrest Events

研究概览

简要总结

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.

详细描述

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.

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Prospective

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • 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.

排除标准

  • 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

结局指标

主要结局

Sudden Cardiac Arrest Events

时间窗: Through study completion, an average of 3 years

The primary end-point will be SCA or ICD equivalent as used in PAREPET. This will consist of ICD therapies for ventricular fibrillation or ventricular tachycardia \>240 bpm, and adjudicated arrhythmic death using the modified Hinkle-Thaler criteria.

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

JOHN CANTY

SUNY Distinguished Professor

State University of New York at Buffalo

研究点 (1)

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