PRE-DETERMINE: Biologic Markers and MRI SCD Cohort Study
预先确定:生物标志物和 MRI SCD 队列研究
基本信息
- 批准号:7687379
- 负责人:
- 金额:$ 142.49万
- 依托单位:
- 依托单位国家:美国
- 项目类别:
- 财政年份:2008
- 资助国家:美国
- 起止时间:2008-09-15 至 2013-06-30
- 项目状态:已结题
- 来源:
- 关键词:Adrenergic AgentsApplications GrantsArrhythmiaBiological MarkersBiological MarkersBloodBlood specimenCardiacCardiac DeathCessation of lifeCicatrixClinicalClinical TrialsCodeCohort StudiesCongestive Heart FailureCoronary heart diseaseDataDefibrillatorsDevicesElectrocardiogramEligibility DeterminationEnrollmentEnvironmental Risk FactorEventFibrosisFunctional disorderGenesGeneticGenetic MarkersGoalsHabitsHeart ArrestImageImage AnalysisImplantable DefibrillatorsIncidenceIndividualInfarctionInflammationInflammation MediatorsIon ChannelIschemiaLeadLeft Ventricular Ejection FractionLeft Ventricular FunctionLeft Ventricular MassLifeLife StyleMagnetic Resonance ImagingMeasuresMedicalMembraneMetabolicMethodsMyocardialMyocardial dysfunctionNational Heart, Lung, and Blood InstituteParentsPatientsPlasmaPopulationPopulations at RiskPredictive ValuePrevention strategyPrevention therapyProcessProteinsPublic HealthQuality of lifeRandomized Controlled Clinical TrialsReceptor SignalingResearch InfrastructureRiskRisk FactorsSaint Jude Children&aposs Research HospitalScreening procedureSeriesStretchingStructural ProteinTestingTimeUnited StatesVariantVentricularVentricular ArrhythmiaWorkadrenergicbasecohortcostfollow-uphigh riskimprovedmortalitynovelnovel therapeutic interventionpredictive modelingprospectivepublic health relevancesudden cardiac deathtooltrend
项目摘要
DESCRIPTION (provided by applicant): There are an estimated 250,000-400,000 sudden cardiac deaths (SCD) annually in the United States constituting approximately 50% of all cardiac deaths. Although clinical trials have demonstrated convincing survival benefits conferred by implantable cardioverter defibrillator (ICD) therapy in selected patients with left ventricular ejection fractions (LVEF) less than 35% and congestive heart failure, the overwhelming majority of patients who suffer a cardiac arrest will have an LVEF> 0.35. This grant application, "PRE-DETERMINE: Biologic Markers and MRI SCD Cohort Study," seeks to identify patients at a substantially higher risk of arrhythmic death among CHD patients with preserved left ventricular ejection fractions (LVEF>35%). The application takes advantage of a planned randomized trial, the Defibrillators To Reduce Risk by Magnetic Resonance Imaging Evaluation (DETERMINE) trial sponsored by St. Jude Medical to assemble a unique prospective cohort of patients who do not presently have an indication for ICD therapy based upon left ventricular function. The additional support from the NHLBI will provide a unique and timely opportunity to take advantage of the assembly of patients screened for the trial who will have contrast-enhanced magnetic resonance imaging (CE-MRI) scans to create an invaluable cohort of 5300 patients with preserved LVEFs where the underlying cardiac substrate is well-defined by MRI imaging and where clinical information, lifestyle habits, electrocardiograms, and blood samples will be collected at baseline and sudden arrhythmic events will be documented over the follow-up period. In years 4-5, the predictive value of promising protein, genetic, and metabolic biomarkers in combination with advanced substrate imaging on the risk of arrhythmic events will be examined in the 6850 patients enrolled in both the observational PRE-DETERMINE cohort and in the parent DETERMINE randomized trial. The goal is to arrive at a series of markers that alone or in combination specifically predict risk of arrhythmic death as compared to other causes of mortality among this at risk population of CHD patients. If biomarkers or genetic markers are identified that can specifically predict risk of ventricular arrhythmias, then these markers may serve as relatively inexpensive methods to identify those at risk. PUBLIC HEALTH RELEVANCE: The public health impact of identifying markers could be quite substantial, leading to more efficient utilization of ICDs and advances in our understanding of mechanisms underlying SCD. The goal of this application is to improve our ability to identify patients who will die suddenly from coronary heart disease through the study of genes and blood markers. If these markers can predict risk of dying suddenly, then they may serve as relatively inexpensive methods to identify those patients at risk. The public health impact of identifying such markers could be quite substantial, leading to more efficient utilization of implantable cardioverter defibrillators and advances in our understanding of mechanisms underlying life-threatening rhythm disturbances.
描述(由申请人提供):美国每年估计有 250,000-400,000 例心源性猝死 (SCD),约占所有心源性死亡的 50%。尽管临床试验已经证明植入式心脏复律除颤器 (ICD) 治疗对某些左心室射血分数 (LVEF) 低于 35% 且患有充血性心力衰竭的患者具有令人信服的生存益处,但绝大多数心脏骤停患者的 LVEF > 0.35。这项拨款申请“预先确定:生物标志物和 MRI SCD 队列研究”旨在确定左心室射血分数保留 (LVEF>35%) 的 CHD 患者中心律失常死亡风险显着较高的患者。该应用程序利用了一项计划中的随机试验,即由 St. Jude Medical 赞助的除颤器通过磁共振成像评估降低风险 (DETERMINE) 试验,以收集目前没有根据左心室功能进行 ICD 治疗指征的患者的独特前瞻性队列。 NHLBI 的额外支持将提供一个独特而及时的机会,利用为试验筛选的患者集合,这些患者将进行对比增强磁共振成像 (CE-MRI) 扫描,以创建一个由 5300 名左心室射血分数保留的患者组成的宝贵队列,其中潜在的心脏基质通过 MRI 成像明确定义,并且临床信息、生活习惯、心电图和 将在基线时收集血样,并在随访期间记录突发心律失常事件。在第 4-5 年,将在参加观察性 PRE-DETERMINE 队列和父 DETERMINE 随机试验的 6850 名患者中检查有前景的蛋白质、遗传和代谢生物标志物与先进基质成像相结合对心律失常事件风险的预测价值。我们的目标是找到一系列标志物,这些标志物可以单独或组合起来专门预测冠心病高危人群中心律失常死亡的风险(与其他死亡原因相比)。如果鉴定出可以特异性预测室性心律失常风险的生物标志物或遗传标志物,那么这些标志物可以作为相对便宜的方法来识别处于危险中的人。 公共卫生相关性:识别标志物对公共卫生的影响可能相当大,从而可以更有效地利用 ICD 并加深我们对 SCD 机制的理解。该应用程序的目标是通过基因和血液标记物的研究,提高我们识别因冠心病突然死亡的患者的能力。如果这些标记物可以预测突然死亡的风险,那么它们可能会成为识别处于危险中的患者的相对廉价的方法。识别这些标记物对公共健康的影响可能相当大,从而可以更有效地利用植入式心律转复除颤器,并加深我们对危及生命的节律紊乱的机制的理解。
项目成果
期刊论文数量(0)
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CHRISTINE M ALBERT其他文献
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{{ truncateString('CHRISTINE M ALBERT', 18)}}的其他基金
PRE-DETERMINE: Advancing Sudden Arrhythmic Death Prediction in Coronary Artery Disease in the Absence of Severe Systolic Dysfunction
预先确定:在没有严重收缩功能障碍的情况下推进冠状动脉疾病的心律失常性猝死预测
- 批准号:
10608859 - 财政年份:2023
- 资助金额:
$ 142.49万 - 项目类别:
Predisposing Factors for the Development of Atrial Fibrillation Among Women
女性房颤发生的诱发因素
- 批准号:
7739967 - 财政年份:2009
- 资助金额:
$ 142.49万 - 项目类别:
Predisposing Factors for the Development of Atrial Fibrillation Among Women
女性房颤发生的诱发因素
- 批准号:
7891235 - 财政年份:2009
- 资助金额:
$ 142.49万 - 项目类别:
PRE-DETERMINE: Biologic Markers and MRI SCD Cohort Study
预先确定:生物标志物和 MRI SCD 队列研究
- 批准号:
8090321 - 财政年份:2008
- 资助金额:
$ 142.49万 - 项目类别:
Pre-DETERMINE: Biologic Markers and MRI SCD Cohort Study
预确定:生物标志物和 MRI SCD 队列研究
- 批准号:
9462839 - 财政年份:2008
- 资助金额:
$ 142.49万 - 项目类别:
PRE-DETERMINE: Biologic Markers and MRI SCD Cohort Study
预先确定:生物标志物和 MRI SCD 队列研究
- 批准号:
8536353 - 财政年份:2008
- 资助金额:
$ 142.49万 - 项目类别:
Pre-DETERMINE: Biologic Markers and MRI SCD Cohort Study
预确定:生物标志物和 MRI SCD 队列研究
- 批准号:
9310983 - 财政年份:2008
- 资助金额:
$ 142.49万 - 项目类别: