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Scandinavian Multicenter Study to Advance Risk Stratification in Heart Disease- Ventricular Arrhythmias (SMASH 1)

2020年6月2日更新者：Torbjorn Omland、University Hospital, Akershus

Scandinavian Multicenter Study to Advance Risk Stratification in Heart Disease- Ventricular Arrhythmias: A Multicenter, Observational Trial

The purpose of this study is to identify markers of increased risk for incident ventricular arrhythmias and cardiovascular events in patients already being treated with an implantable cardioverter-defibrillator (ICD) by exploring patient history and clinical findings, biological markers, ECG markers, and echocardiographic markers.

研究概览

地位

主动，不招人

条件

详细说明

This is a multicenter prospective cohort study to assess the prognostic value of potential biomarkers for incident ventricular arrhythmias and cardiovascular events in patients with implantable cardioverter-defibrillator (ICD). In addition to information from the baseline visit and future study visits, the investigators will also register information from the patients medical records concerning comorbidities and previous medical events.

The data will be summarized with respect to demographic and baseline characteristics and risk markers/ measurements. The final diagnosis of incident cardiovascular events will be established by an adjudication committee with two senior physicians reviewing all information available on the patients, including information on the clinical outcome of the patient. The investigators will use multivariate statistical models to assess the individual performance of biomarkers/other tests.

研究类型

观察性的

注册 (实际的)

504

联系人和位置

本节提供了进行研究的人员的详细联系信息，以及有关进行该研究的地点的信息。

学习地点

挪威
- - Lørenskog、挪威、1478
    - Akershus University Hospital

参与标准

研究人员寻找符合特定描述的人，称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。

资格标准

适合学习的年龄

18年及以上 (成人、年长者)

接受健康志愿者

不

有资格学习的性别

全部

取样方法

非概率样本

研究人群

Patients treated with an ICD. Inclusion from outpatient clinic.

描述

Inclusion Criteria:

Patients ≥ 18 years old
Current treatment with an ICD
Signed written informed consent before study commencement

Exclusion Criteria:

Participation in other interventional clinical trial or previously included in the current study
Patients not able to provide written informed consent
Known or suspected, non-curable cancer,
Neurological condition with short life expectancy; e.g. amyotropic lateral sclerosis (ALS)
Patients unwilling or unable to comply with the protocol
History of non-compliance to medical management and patients who are considered potentially unreliable by the Investigator
History or evidence of alcohol or drug abuse with the last 12 months that may influence the participation of the patient in the study, as assessed by the Investigator during the screening phase
Any surgical or medical condition, which in the option of the Investigator, will impair the ability of the patient to participate in the study

学习计划

本节提供研究计划的详细信息，包括研究的设计方式和研究的衡量标准。

研究是如何设计的？

设计细节

观测模型：队列
时间观点：预期

团体/队列数

队列和干预

团体/队列
1 Derivation cohort (n=474); may be analyzed separately or combined with cohort #2 to enhance statistical power
2 Validation cohort (patient #475 and after); may be combined with cohort #1 to enhance statistical power

研究衡量的是什么？

主要结果指标

结果测量	措施说明	大体时间
Episodes of ventricular fibrillation (VF) or ventricular tachycardia (VT) resulting in appropriately delivered ICD therapies (including antitachycardia pacing) or sustained ventricular tachyarrhythmia (>100/min, >30sek). 大体时间：Duration of follow-up will be a minimum of 180 days following inclusion of the final patient.	Registered from the monitoring function of the ICD	Duration of follow-up will be a minimum of 180 days following inclusion of the final patient.

次要结果测量

结果测量	大体时间
All-cause mortality 大体时间：Duration of follow-up will be a minimum of 180 days following inclusion of the final patient.	Duration of follow-up will be a minimum of 180 days following inclusion of the final patient.
Cardiovascular mortality 大体时间：Duration of follow-up will be a minimum of 180 days following inclusion of the final patient.	Duration of follow-up will be a minimum of 180 days following inclusion of the final patient.
Major adverse cardiac event (MACE), i.e. acute myocardial infarction, stroke, urgent myocardial revascularization and cardiovascular mortality 大体时间：Duration of follow-up will be a minimum of 180 days following inclusion of the final patient.	Duration of follow-up will be a minimum of 180 days following inclusion of the final patient.
Heart failure hospitalization 大体时间：Duration of follow-up will be a minimum of 180 days following inclusion of the final patient.	Duration of follow-up will be a minimum of 180 days following inclusion of the final patient.
The combination of cardiovascular mortality and heart failure hospitalizations 大体时间：Duration of follow-up will be a minimum of 180 days following inclusion of the final patient.	Duration of follow-up will be a minimum of 180 days following inclusion of the final patient.
Number of premature ventricular complexes (PVCs) and non-sustained VT (> 3 coupled PVCs) registered from the monitoring function of the ICD 大体时间：Duration of follow-up will be a minimum of 180 days following inclusion of the final patient.	Duration of follow-up will be a minimum of 180 days following inclusion of the final patient.
New occurrence of supra-ventricular arrhythmias (i.e. atrial fibrillation, atrial flutter, atrial tachycardia etc.) 大体时间：Duration of follow-up will be a minimum of 180 days following inclusion of the final patient.	Duration of follow-up will be a minimum of 180 days following inclusion of the final patient.
Episodes of ventricular- or supra-ventricular arrhythmias (specified above) registered from the monitoring function of the ICD. 大体时间：Duration of follow-up will be a minimum of 180 days following inclusion of the final patient.	Duration of follow-up will be a minimum of 180 days following inclusion of the final patient.

合作者和调查者

在这里您可以找到参与这项研究的人员和组织。

赞助

University Hospital, Akershus

合作者

University of Oslo

Helse Stavanger HF

调查人员

首席研究员：Torbjørn Omland, MD,PhD, MPH、Professor of Medicine

研究记录日期

这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查，以确保它们在发布到公共网站之前符合特定的质量控制标准。

研究主要日期

学习开始 (实际的)

2016年8月1日

初级完成 (实际的)

2019年12月31日

研究完成 (预期的)

2050年12月1日

研究注册日期

首次提交

2016年7月1日

首先提交符合 QC 标准的

2016年8月11日

首次发布 (估计)

2016年8月12日

研究记录更新

最后更新发布 (实际的)

2020年6月4日

上次提交的符合 QC 标准的更新

2020年6月2日

最后验证

2020年6月1日