Risk Stratification in MADIT II Type Patients

MADIT II 型患者的风险分层

• 批准号: 7071782
• 负责人: Wojciech Zareba
• 金额: $ 74.42万
• 依托单位: UNIVERSITY OF ROCHESTER
• 依托单位国家: 美国
• 财政年份: 2005
• 资助国家: 美国
• 起止时间: 2005-06-01 至 2009-05-31
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/7071782
• 关键词: atrial fibrillation; bioimaging /biomedical imaging; cardiovascular disorder therapy; clinical research; computer assisted medical decision making; computer program /software; cost effectiveness; electrocardiographic monitor; electrocardiography; human mortality; human subject; implantable defibrillators; mathematical model; medical implant science; model design /development; myocardial infarction; noninvasive diagnosis; patient safety /medical error; prognosis; quality of life; sudden cardiac death; tachycardia; ventricular fibrillation

DESCRIPTION (provided by applicant): Recently, the Multicenter Automatic Defibrillator Implantation Trial II (MADIT II) demonstrated that post-infarction patients with advanced left ventricular dysfunction, defined by ejection fraction equal to or < 30%, have a very high 19.6% 20-month mortality which was reduced by 28% with prophylactic implantation of a cardioverter-defibrillators. Over 30% of patients with SCDs receive appropriate therapy for ventricular tachycardia or ventricular fibrillation. Similar reduction in mortality associated with ICD therapy was recently reported from the Sudden Cardiac Death in Heart Failure Trial (SCD-HeFT). Since the population of patients eligible for an ICD following MADIT II indications is very large, there is a great interest in developing methods and algorithms for identifying high- and low-risk individuals among MADIT ll-type patients to prioritize them for ICD therapy. Based on previous experience and recent preliminary analyses from the MADIT II data, we hypothesize that a combination of clinical variables and noninvasive ECG parameters, indicating contribution of different mechanisms that predispose to arrhythmias and sudden death, will allow identification of patients with increased benefit and those with little benefit from ICD therapy. Therefore, the primary aims of this study are: 1) to evaluate the predictive value of a multivariate model consisting of pre-specified clinical and ECG parameters for predicting arrhythmic events in MADIT II type postinfarction patients with severe left ventricular dysfunction; 2) to develop a multivariate risk-stratification model, based on a broader spectrum of pre-specified clinical covariates and ECG parameters, and from it a risk-scoring algorithm identifying high-risk and low-risk patient groups; this algorithm will be validated by a cross-validation study. Such an algorithm will enable an ordering of patients who may benefit most, and benefit least, from ICD therapy. The secondary objectives of this study are: 1) to determine the prognostic significance of clinical and noninvasive ECG variables for predicting non-sudden (non-arrhythmic) cardiac mortality in MADIT II type patients; identifying such individuals will further refine clinical practice and cost-effectiveness of primary prevention of SCO with ICD therapy; 2) to identify ECG predictors of inappropriate therapy delivered for episodes of atrial fibrillation or supraventricular tachyarrhythmias and evaluate the association between inappropriate therapy and the risk of ventricular tachyarrhythmias; 3) to determine whether clinical and ECG predictors contribute to identification of patients with worsening quality of life, and compare changes in quality of life of patients experiencing ICD therapy with those who do not, after adjusting for clinical and ECG parameters.

描述（由申请人提供）：最近，多中心自动除颤器植入试验II（MADIT II）表明，在高级左心室功能障碍的界面后患者（由射血分数等于或<30％）定义，具有非常高的19.6％20个20个月的死亡率，与预知型的无性症相关的28％可将其减少28％。超过30％的SCD患者接受适当的心室心动过速或心室纤维化治疗。最近从心力衰竭试验（SCD-HEFT）的心脏猝死中报道了与ICD治疗相关的死亡率类似的降低。由于MADIT II指示后有资格获得ICD的患者人口非常大，因此人们对开发Madit LL-type患者中的高风险患者的方法和算法非常感兴趣，以将其优先考虑ICD治疗。根据MADIT II数据的先前经验和最新的初步分析，我们假设临床变量和非侵入性ECG参数的结合表明，不同机制的贡献，这些机制易受到心律失常和猝死，将允许对患者的识别和ICD治疗受益的增加，而ICD治疗却很少受益。因此，这项研究的主要目的是：1）评估由预先指定的临床和ECG参数组成的多变量模型的预测价值，用于预测MADIT II类型的心律失常后发生的心律不齐后，患有严重的左心室功能障碍患者； 2）基于较广泛的预先指定的临床协变量和ECG参数开发多元风险分层模型，并从中鉴定出风险评分算法，以识别高风险和低风险患者群体；该算法将通过交叉验证研究来验证。这种算法将使可能受益最多，至少从ICD治疗中受益的患者订购。这项研究的次要目标是：1）确定MADIT II类型患者中临床和非侵入性ECG变量预测非苏德顿（非心律失常）心脏死亡率的预后意义；确定此类人将进一步完善ICD治疗初级预防SCO的临床实践和成本效益； 2）确定对心房颤动或室外心律失常的发作的不当治疗的ECG预测因素，并评估不当治疗与心室心律失常的风险之间的关联； 3）确定临床和心电图预测因素是否有助于鉴定生活质量恶化的患者，并比较经过ICD治疗的患者的生活质量变化与未经ICD治疗的患者进行调整后，在调整了临床和ECG参数后。