跳至主要内容
临床试验/NCT04599439
NCT04599439招募中不适用

CMR Based Prediction of Ventricular Tachycardia Events in Healed Myocardial Infarction (DEVELOP-VT)

Centro Medico Teknon1 个研究点 分布在 1 个国家目标入组 1,000 人开始时间: 2020年8月1日最近更新:
适应症

试验速览

阶段
不适用
状态
招募中
发起方
入组人数
1,000
试验地点
1
主要终点
Ventricular arrhythmias or sudden cardiac death

研究概览

简要总结

Fibrotic tissue is known to be the substrate for the appearance of scar-related reentrant ventricular arrhythmias (VA) in chronic ischemic cardiomyopathy (ICM). Late gadolinium enhancement cardiac magnetic resonance (LGE-CMR) has proven to be a useful technique in the non-invasive characterization of the scarred tissue and the underlying arrhythmogenic substrate. Previous studies identified the presence of significant scarring (> 5% of the left ventricular -LV- mass) is an independent predictor of adverse outcome (all-cause mortality or appropriate ICD discharge for ventricular tachycardia or fibrillation) in patients being considered for implantable cardioverter-defibrillator (ICD) placement. Parallelly, the presence of heterogeneous tissue channels, which correlate with voltage channels after endocardial voltage mapping of the scar, can be more frequently observed in patients suffering from sustained monomorphic ventricular tachycardias (SMVT) than in matched controls for age, sex, infarct location, and left ventricular ejection fraction (LVEF). However, the lack of solid evidence and randomized trials make LVEF still the main decision parameter when assessing suitability for ICD implantation in primary prevention of sudden cardiac death (SCD). In a recent, case-control study, we identified the border zone channel (BZC) mass as the only independent predictor for VT occurrence, after matching for age, sex, LVEF and total scar mass. This BZC mass can be automatically calculated using a commercially available, post-processing imaging platform named ADAS 3D LV (ADAS3D Medical, Barcelona, Spain), with FDA 510(k) Clearance and European Community Mark approval. Thus, CMR-derived BZC mass might be used as an automatically reproducible criterium to reclassify those patients with chronic ICM at highest risk for developing VA/SCD in a relatively short period of approx. 2 years.

In the present cohort study, we sought to evaluate the usefulness of the BZC mass measurement to predict the occurrence of VT events in a prospective, multicenter, unselected series of consecutive chronic ischemic patients without previous arrhythmia evidence, irrespectively of their LVEF.

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

  • Age > 18 years.
  • Chronic (> 3 months after the index coronary event), stable ischemic heart disease, irrespectively of the LVEF.
  • Life expectancy of > 1 year with a good functional status.
  • Signed informed consent.

排除标准

  • Age < 18 years.
  • Pregnancy.
  • Life expectancy of < 1 year, or bad functional status (NYHA IV functional class).
  • Other concomitant structural heart diseases (e.g. congenital, non-ischemic, etc.)
  • Previously documented sustained ventricular arrhythmias.
  • Impossibility or contraindications to undergo a contrast-enhanced CMR study.
  • Concomitant investigation treatments.
  • Medical, geographical and social factors that make study participation impractical, and inability to give written informed consent. Patient's refusal to participate in the study.

结局指标

主要结局

Ventricular arrhythmias or sudden cardiac death

时间窗: 2 years

Clinical composite of cardiac death or any sustained ventricular arrhythmia after a 2-year follow-up period.

次要结局

  • Non-cardiac causes of mortality(2 years)
  • Heart failure hospitalization rate(2 years)

研究者

发起方
Centro Medico Teknon
申办方类型
Other
责任方
Principal Investigator
主要研究者

Antonio Berruezo, MD, PhD

Head of Arrhythmia Department & Director of Research and Innovation

Centro Medico Teknon

研究点 (1)

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