Data Analysis and Evaluation of the Incidence of Life-threatening Ventricular Arrhythmias in Patients with Newly Diagnosed Cardiomyopathies of NICM or MI/CAD Origin PROTECTED from SCD by a WCD
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 19,598
- 试验地点
- 1
- 主要终点
- Incidence of SCD/SCA
研究概览
简要总结
SCD-PROTECT is an epidemiological, observational, multicenter study to assess the incidence of sudden cardiac arrest/death (SCA/SCD) in patients with newly diagnosed non-ischemic cardiomyopathy or with myocardial infarction/coronary artery disease. Data on SCA/SCD risk in the early phase of disease, especially during medication up-titration while left ventricular ejection fraction is reduced, are sparse.
详细描述
SCD-PROTECT is an epidemiological, observational, multicenter study, evaluating the incidence of sudden cardiac arrest (SCA) / sudden cardiac death (SCD) in patients with reduced left ventricular ejection fraction (LVEF) due to newly diagnosed non-ischemic cardiomyopathy (NICM) or a myocardial infarction/coronary artery disease with intervention (MI/CAD). In the early phase (3 months) during up-titration of guideline-recommended therapy (GRMT) a wearable cardioverter defibrillator (WCD) can be indicated due to increased risk for SCA/SCD in these patients. The WCD provides continuous arrhythmia monitoring, detection of life-threatening ventricular arrhythmias, and provides automatic defibrillation within a minute of detection of a potentially fatal ventricular tachyarrhythmia whatever the cause of increased risk of SCD. Currently, detailed data for risk of SCA/SCD in patients with NICM or MI/CAD during the early phase are sparse.
The SCD-PROTECT study is a comprehensive, nationwide analysis of at least 18.000 consecutive patients using a WCD (LifeVest®, ZOLL, Pittsburgh, PA, USA) in Germany to evaluate the risk of SCA/SCD in the early phase of disease.
All patients who received a WCD (LifeVest®, ZOLL, Pittsburgh, PA, USA) from December 2021 to May 2023 in Germany will be screened for inclusion. Observation period will start with first ECG recording of the WCD and terminates with individual end-of-WCD-use. Primary objective is the SCA/SCD incidence, measured by the percentage of patients with at least one appropriate treatment (appropriate shock) delivered and automatically recorded by WCD. The incidence density of appropriate shocks per 100 patient years will also be calculated.
Secondary objectives include inappropriate WCD treatments, mortality and side effects during WCD wearing time. Exploratory objectives are trajectory of LVEF, compliance with WCD use, time to first appropriate shock from beginning of wearing time until first WCD shock and incidences of appropriate shocks (primary endpoint) by subtype of NICM or MI/CAD.
NICM and MI/CAD sub-types are categorized by the investigator team at baseline and may include the following: DCM, Myocarditis, PPCM, Tako-Tsubo CM, Tachymyopathy, Toxic CM, Sarcoidosis Genetic/Congenital, and others vs. Post Myocardial Infarction, Coronary Heart Disease and others.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Other
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Subjects must be 18 years of age or older.
- •Subjects must be prescribed a WCD for a high risk of SCD.
- •Subjects must have been fitted with a WCD, and a baseline for ECG-analysis must have been established.
- •Subjects must have worn the WCD; time zero of inclusion is the activation of the ECG.
- •Subjects must have had a diagnosis of newly diagnosed NICM or MI/CAD with reduced LVEF as indication for WCD prescription.
排除标准
- •No specific exclusion criteria will be applied.
结局指标
主要结局
Incidence of SCD/SCA
时间窗: Observation period starts with baseline of WCD-use and continues through end of WCD-use, an average of 2-3 months
Incidence of patients with NICM or MI/CAD with at least one appropriate treatment (appropriate shock) observed during WCD-use. Treatment events will be automatically recorded through the monitoring device. The incidence density of appropriate shocks per 100 patient years will also be calculated.
次要结局
- Incidence of inappropriate shocks(Observation period starts with baseline of WCD-use and continues through end of WCD-use, an average of 2-3 months)
- Mortality(Observation period starts with baseline of WCD-use and continues through end of WCD-use, an average of 2-3 months)
- Adverse events(Observation period starts with baseline of WCD-use and continues through end of WCD-use, an average of 2-3 months)
研究者
David Duncker
Head of Hannover Heart Rhythm Center, Department of Cardiology and Angiology
Hannover Medical School