Circulating RNA Markers of Ventricular Arrhythmias in Remotely Monitored Patients With Post-Infarction Heart Failure and Implanted Cardioverter-Defibrillators
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
연구 개요
상세 설명
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.
연구 유형
등록 (실제)
연락처 및 위치
연구 장소
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Podkarpackie Voivodeship
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Rzeszów, Podkarpackie Voivodeship, 폴란드, 35-301
- Clinical Provincial Hospital No. 2 in Rzeszow
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참여기준
자격 기준
공부할 수 있는 나이
- 성인
- 고령자
건강한 자원 봉사자를 받아들입니다
샘플링 방법
연구 인구
설명
Inclusion Criteria:
- 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
Exclusion Criteria:
- Age younger than 18 years
- Lack of informed consent or withdrawal of consent
- Concurrent participation in another study evaluating a drug or therapeutic intervention
공부 계획
연구는 어떻게 설계됩니까?
디자인 세부사항
코호트 및 개입
그룹/코호트 |
개입 / 치료 |
|---|---|
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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.
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Peripheral blood collection followed by laboratory isolation and sequencing of circulating small RNAs, with primary focus on microRNAs.
The molecular results are analyzed as research biomarkers and are not used to assign treatment or alter routine clinical management.
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연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
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Differential Expression of Circulating Small Non-Coding RNAs by Ventricular Arrhythmia Phenotype
기간: At blood collection; arrhythmia phenotype determined from device records available through blood collection
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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.
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At blood collection; arrhythmia phenotype determined from device records available through blood collection
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Occurrence of Sustained Ventricular Arrhythmia Requiring ICD Therapy
기간: From blood collection through 6 months
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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.
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From blood collection through 6 months
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2차 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
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Long-Term Occurrence of Sustained Ventricular Arrhythmia Requiring ICD Therapy
기간: From blood collection through 3 years
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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 during extended routine remote monitoring.
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From blood collection through 3 years
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공동 작업자 및 조사자
연구 기록 날짜
연구 주요 날짜
연구 시작 (실제)
기본 완료 (추정된)
연구 완료 (추정된)
연구 등록 날짜
최초 제출
QC 기준을 충족하는 최초 제출
처음 게시됨 (실제)
연구 기록 업데이트
마지막 업데이트 게시됨 (실제)
QC 기준을 충족하는 마지막 업데이트 제출
마지막으로 확인됨
추가 정보
이 연구와 관련된 용어
추가 관련 MeSH 약관
기타 연구 ID 번호
- UR-RNA-VA-2025-01
- 2025/09/X/NZ2/00644 (기타 보조금/기금 번호: National Science Centre, Poland)
개별 참가자 데이터(IPD) 계획
개별 참가자 데이터(IPD)를 공유할 계획입니까?
약물 및 장치 정보, 연구 문서
미국 FDA 규제 의약품 연구
미국 FDA 규제 기기 제품 연구
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