Diagnostic Data Influence on Disease Management and Relation of Genetic Polymorphisms to Tachy-arrhythmia in ICD Patients.
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 1,223
- 主要终点
- Number of Patients With Ventricular Arrhythmia <400 Msec. by GNAS c.2273C>T Genotype
研究概览
简要总结
To prospectively evaluate if the analysis of genetic polymorphisms can be used to identify patients at risk of ventricular tachycardia.
To evaluate the influence of ICD-based diagnostic information on the long term treatment and management of primary prevention ICD-patients.
详细描述
Evaluate the positive predictive value of single nucleotide polymorphisms (SNPs) in the genes GNB3, GNAS and GNAQ as predictors of ventricular arrhythmia <400 msec.
- Evaluate the positive predictive value of Single Nucleotide Polymorphisms as predictor for death, cardiac death and atrial fibrillation/flutter in the genes GNB3, GNAS, GNAQ and other SNPs involving signal transduction components which impact on the activity of cardiac ion channels.
- Evaluate the best combination of genetic parameters, baseline data and follow-up data as predictor of primary endpoint, All cause Mortality, cardiac death and atrial arrhythmia.
- Evaluate the usage of ICD-system diagnostics (battery status, impedance, pacing threshold, sensing) resulting in medical consequences*.
- Evaluate the usage of ICD-based patient diagnostics (arrhythmia, IEGM, heart frequency, %pacing, Cardiac Compass) resulting in medical consequences*.
- Evaluate the frequency of programming changes involving AF-prevention and AF-therapy algorithms.
- Evaluate the frequency of pacing-parameter programming changes and the resulting medical consequences*.
- Medical consequences include: Hospitalization, medical interventions, medication, surgery, additional diagnostics and ICD-programming changes.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Diagnostic
- 盲法
- Triple (Participant, Care Provider, Investigator)
盲法说明
patients and investigators were blinded to the genetic markers during the study. Therefore, no arm is specified as this is not applicable.
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
- •Implantation of a market approved Medtronic Dual-chamber ICD with long term clinical trends Cardiac Compass,
- •Subjects requiring the implantation of an ICD for primary prevention according to the current AHA/ACC/ESC guidelines,
- •Subject able to comply with the Clinical InvestigationPlan,
- •Subject is expected to remain available for follow-up visits,
- •Subject has signed the informed consent form within 10 days of implant,
- •The system implanted for this study is the first ICD implant for patient.
排除标准
- •Women who are pregnant, or women of childbearing potential not on a reliable form of birth control,
- •Subject is enrolled in a concurrent study that may confound the results of this study,
- •Subject has a life expectancy less than two years,
- •Subject is post heart transplant or awaiting heart transplantation,
- •Subject is anticipated to demonstrate poor compliance,
- •Subjects with syndromes known to be associated with ion channel pathologies such as:
- •Long- or short-QT Syndrome
- •Brugada Syndrome
- •Catecholaminergic Polymorphic Ventricular Tachycardia (CPTV ).
研究组 & 干预措施
ICD Therapy, blood sampling
Blood sampling Defibrillator, Dual Chamber ; Implantable
干预措施: Defibrillator, Dual Chamber ; Implantable (Device)
ICD Therapy, blood sampling
Blood sampling Defibrillator, Dual Chamber ; Implantable
干预措施: Blood sampling (Procedure)
结局指标
主要结局
Number of Patients With Ventricular Arrhythmia <400 Msec. by GNAS c.2273C>T Genotype
时间窗: 2 years
The GNAS c.2273C\>T single nucleotide polymorphism (SNP) was one of seven SNP's analyzed. Patients with de novo ICD implants were genotyped and followed for up to 2 years. All episodes of arrhythmia \<400 msec. detected by the device were adjudicated by an independent committee. The number of patients with true arrhythmias \<400 msec were tracked by genotype.
Number of Patients With Ventricular Arrhythmia <400 Msec. by GNAQ c.-909/-908GC>TT Genotype
时间窗: 2 years
The GNAQ c.-909/-908GC\>TT single nucleotide polymorphism (SNP) was one of seven SNP's analyzed. Patients with de novo ICD implants were genotyped and followed for up to 2 years. All episodes of arrhythmia \<400 msec. detected by the device were adjudicated by an independent committee. The number of patients with true arrhythmias \<400 msec were tracked by genotype.
Outcome Measure Title: Number of Patients With Ventricular Arrhythmia <400 Msec. by GNB3 c.825C>T Genotype
时间窗: 2 years
The GNB3 c.825C\>T single nucleotide polymorphism (SNP) was one of seven SNP's analyzed. Patients with de novo ICD implants were genotyped and followed for up to 2 years. All episodes of arrhythmia \<400 msec. detected by the device were adjudicated by an independent committee. The number of patients with true arrhythmias \<400 msec were tracked by genotype.
Number of Patients With Ventricular Arrhythmia <400 Msec. by GNAS c.393C>T Genotype
时间窗: 2 years
The GNAS c.393C\>T single nucleotide polymorphism (SNP) was one of seven SNP's analyzed. Patients with de novo ICD implants were genotyped and followed for up to 2 years. All episodes of arrhythmia \<400 msec. detected by the device were adjudicated by an independent committee. The number of patients with true arrhythmias \<400 msec were tracked by genotype.
Number of Patients With Ventricular Arrhythmia <400 Msec. by GNAS c.2291C>T Genotype
时间窗: 2 years
The GNAS c.2291C\>T single nucleotide polymorphism (SNP) was one of seven SNP's analyzed. Patients with de novo ICD implants were genotyped and followed for up to 2 years. All episodes of arrhythmia \<400 msec. detected by the device were adjudicated by an independent committee. The number of patients with true arrhythmias \<400 msec were tracked by genotype.
Number of Patients With Ventricular Arrhythmia <400 Msec. by GNAQ c.-382G>A Genotype
时间窗: 2 years
The GNAQ c.-382G\>A single nucleotide polymorphism (SNP) was one of seven SNP's analyzed. Patients with de novo ICD implants were genotyped and followed for up to 2 years. All episodes of arrhythmia \<400 msec. detected by the device were adjudicated by an independent committee. The number of patients with true arrhythmias \<400 msec were tracked by genotype.
Number of Patients With Ventricular Arrhythmia <400 Msec. by GNAQ c.-387G>A Genotype
时间窗: 2 years
The GNAQ c.-387G\>A single nucleotide polymorphism (SNP) was one of seven SNP's analyzed. Patients with de novo ICD implants were genotyped and followed for up to 2 years. All episodes of arrhythmia \<400 msec. detected by the device were adjudicated by an independent committee. The number of patients with true arrhythmias \<400 msec were tracked by genotype.
次要结局
- Hospitalization, Medical Interventions, Medication, Surgery, Additional Diagnostics(2 years)
- All Cause Mortality, Cardiac Death and Atrial Fibrillation/Flutter(2 years)