The Role of Non-Coding RNA Molecules as Potential Markers of Ventricular Arrhythmias in Patients With Post-Myocardial Infarction Heart Failure and Implanted Cardioverter-Defibrillators Undergoing Remote Monitoring
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 57
- 试验地点
- 1
- 主要终点
- Differential Expression of Circulating Small Non-Coding RNAs by Ventricular Arrhythmia Phenotype
研究概览
简要总结
This prospective observational study evaluates whether circulating small non-coding RNAs, particularly microRNAs, are associated with ventricular arrhythmias in patients with post-myocardial infarction heart failure who have an implanted cardioverter-defibrillator and are followed by remote monitoring. Blood samples were collected from 57 participants. Small RNA profiles are analyzed in relation to ventricular tachycardia or ventricular fibrillation episodes recorded by the implanted device. Participants are not assigned to any treatment or intervention as part of this study. The initial analysis includes six months of follow-up, with longer-term observational follow-up planned.
详细描述
This is a single-cohort prospective observational biomarker study in patients with post-myocardial infarction heart failure and an implanted cardioverter-defibrillator or cardiac resynchronization therapy defibrillator who are followed through remote device monitoring.
Peripheral blood was collected from 57 participants for analysis of circulating small RNAs. Following laboratory quality control, including assessment of hemolysis and sequencing quality, 48 samples were included in the primary molecular analysis. Small RNA sequencing is used to characterize circulating RNA profiles, with the main analyses focusing on microRNAs.
RNA profiles are evaluated in relation to clinically relevant ventricular arrhythmias documented by the implanted device, including sustained ventricular tachycardia or ventricular fibrillation requiring antitachycardia pacing or shock. The primary prospective observation period is six months after blood collection. Continued long-term follow-up through remote monitoring is planned through March 2029. Existing clinical information and device-recorded arrhythmia history may also be used for exploratory analyses.
No study-specific treatment is assigned and routine clinical management is not altered by participation. The objective is to identify circulating RNA markers associated with an arrhythmogenic phenotype and to generate candidates for subsequent validation.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
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
- •Age 18 years or older
- •Post-myocardial infarction heart failure
- •Previous implantation of an implantable cardioverter-defibrillator or cardiac resynchronization therapy defibrillator
- •Participation in a remote monitoring program for the implanted device
- •Written informed consent
排除标准
- •Age younger than 18 years
- •Lack of informed consent or withdrawal of consent
- •Concurrent participation in another study evaluating a drug or therapeutic intervention
研究组 & 干预措施
Post-Infarction Heart Failure With Implanted Defibrillator
Patients with post-myocardial infarction heart failure and an implanted cardioverter-defibrillator or cardiac resynchronization therapy defibrillator undergoing routine remote monitoring. Circulating small RNA profiles are evaluated in relation to device-recorded ventricular arrhythmias. No treatment is assigned by the study.
干预措施: Circulating Small RNA Profiling (Diagnostic Test)
结局指标
主要结局
Differential Expression of Circulating Small Non-Coding RNAs by Ventricular Arrhythmia Phenotype
时间窗: At blood collection; arrhythmia phenotype determined from device records available through blood collection
Normalized expression levels and log2 fold changes of circulating small non-coding RNAs, primarily microRNAs, are compared between participants with and without device-documented life-threatening ventricular arrhythmias or appropriate ICD therapy. Statistical testing includes correction for multiple comparisons.
Occurrence of Sustained Ventricular Arrhythmia Requiring ICD Therapy
时间窗: From blood collection through 6 months
Number of participants with at least one device-confirmed episode of sustained ventricular tachycardia or ventricular fibrillation treated with antitachycardia pacing or an ICD shock. Events are identified through routine remote device monitoring.
次要结局
- Long-Term Occurrence of Sustained Ventricular Arrhythmia Requiring ICD Therapy(From blood collection through 3 years)
研究者
Mariusz Wójcik
Assistant Professor
University of Rzeszow