- ICH GCP
- 미국 임상 시험 레지스트리
- 임상시험 NCT01944514
Implantable Cardioverter Defibrillators - Improving Risk Stratification (ICD-IRS)
Improving Risk Stratification of Patients for Implantable Cardioverter Defibrillators Through Electrophysiological Tests, Cardiac Magnetic Resonance Imaging, Autonomic Function Tests, RNA Analysis and Plasma Biomarkers.
Worldwide three million people a year die from sudden cardiac death (SCD). In most cases there is no warning and the heart is stopped by a sudden arrhythmia. We know that some people are at high risk of sudden cardiac death and can prevent their deaths with an implantable cardioverter defibrillator (ICD) that is implanted in a minor operation.
However, most people who die from sudden cardiac death are not found to be at high risk by our current risk markers and 40% of the people who have ICDs do not have therapy within the first 4 years after implant. We need new and better ways of identifying people who are at high risk of sudden cardiac death so that we can prevent their deaths with ICDs. Our understanding of the electrical signals in the heart has increased considerably in recent years; in no small part this is due to our Principal Investigator Professor Andre Ng's basic science work. This study aims to take the understanding of action potential duration (APD) restitution gained through our work and other studies in humans and in computer simulations and translate it into a fresh way of assessing risk of sudden cardiac death.
This study will carefully examine electrical activity, using APD restitution, in the hearts of patients who are having ICDs fitted because of their high risk of sudden cardiac death and combine this with a detailed heart scan, assessment of autonomic nervous system and gene expression data. We will then follow these patients up to see who benefits from their ICD. This wide ranging information will give us as complete a picture as possible of the factors that cause sudden cardiac death. We hope to use this to identify better predictors of sudden cardiac death.
The study hypotheses are as follows:
Primary
- Regional Restitution Instability Index (R2I2) will be significantly higher in patients reaching the endpoint of ventricular endpoint / sudden cardiac death than in those not.
An R2I2 cut-off of 1.03 will partition patients into high and low risk groups.
Secondary
- Peri-infarct zone mass in grams will be significantly higher in patients reaching the endpoint of ventricular endpoint / sudden cardiac death than in those not.
연구 개요
상태
연구 유형
등록 (실제)
참여기준
자격 기준
공부할 수 있는 나이
건강한 자원 봉사자를 받아들입니다
연구 대상 성별
샘플링 방법
연구 인구
Ischaemic cardiomyopathy cohort: patients with a history of myocardial infarction attending for ICD implantation / Ventricular tachycardia stimulation test.
Non-Ischaemic cohort: patients without a history of myocardial infarction attending for ICD implantation / Ventricular tachycardia stimulation test.
Control group: Patients with normal hearts and no conditions / family history that increases risk of sudden cardiac death attending for an electrophysiological study.
설명
Inclusion Criteria:
- Attending for ICD implantation under NICE criteria or attending for an ICD box-change procedure or attending for an Electrophysiological test as part of NICE assessment for ICD implantation
- Age >18
- History of ischaemic heart disease or non-ischaemic cardiomyopathy or inherited sudden cardiac death syndrome.
Exclusion Criteria:
- <28 days since acute coronary syndrome / cardiac surgery
- Unable to give informed consent
- Women who are pregnant / planning pregnancy
Contraindication for defibrillator safety margin test
- Haemodynamic instability
- Severe valvular heart disease
- Symptomatic, severe, coronary artery disease
- Recent stroke
공부 계획
연구는 어떻게 설계됩니까?
디자인 세부사항
코호트 및 개입
그룹/코호트 |
---|
Ischaemic cardiomyopathy group
Patients with ischaemic cardiomyopathy attending for ICD implantation / Ventricular tachycardia stimulation testing as part of ICD risk stratification
|
Non-ischaemic cohort
Patients attending for ICD implantation / ventricular tachycardia stimulation test who do not have ischaemic cardiomyopathy.
|
Control group
Patients attending for electrophysiological study with no conditions that place them at risk of sudden cardiac death.
|
연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
---|---|---|
Regional Restitution Instability Index
기간: 18months - 2years
|
Regional Restitution Instability Index (R2I2) is a measure of electrical instability.
R2I2 is calculated as the mean of the standard deviation of the residuals from the mean gradients for each ECG lead across a range of diastolic intervals.
An R2I2 cut-off of 1.03 (no units) will partition the study population into high and low risk groups.
|
18months - 2years
|
2차 결과 측정
결과 측정 |
측정값 설명 |
기간 |
---|---|---|
Peri-infarct zone
기간: 18months-2 years
|
Peri-infarct zone is calculated from cardiac magnetic resonance imaging scans with late gadolinium enhancement.
The full width half maximum technique will be used and Peri-infarct zone assessed using peri-infarct zone mass in grams.
|
18months-2 years
|
공동 작업자 및 조사자
수사관
- 수석 연구원: G. Andre Ng, MBCHb, PhD, University of Leicester
간행물 및 유용한 링크
일반 간행물
- Nicolson WB, McCann GP, Brown PD, Sandilands AJ, Stafford PJ, Schlindwein FS, Samani NJ, Ng GA. A novel surface electrocardiogram-based marker of ventricular arrhythmia risk in patients with ischemic cardiomyopathy. J Am Heart Assoc. 2012 Aug;1(4):e001552. doi: 10.1161/JAHA.112.001552. Epub 2012 Aug 24.
- Nicolson WB, McCann GP, Smith MI, Sandilands AJ, Stafford PJ, Schlindwein FS, Samani NJ, Ng GA. Prospective evaluation of two novel ECG-based restitution biomarkers for prediction of sudden cardiac death risk in ischaemic cardiomyopathy. Heart. 2014 Dec;100(23):1878-85. doi: 10.1136/heartjnl-2014-305672. Epub 2014 Aug 4.
연구 기록 날짜
연구 주요 날짜
연구 시작
기본 완료 (실제)
연구 등록 날짜
최초 제출
QC 기준을 충족하는 최초 제출
처음 게시됨 (추정)
연구 기록 업데이트
마지막 업데이트 게시됨 (추정)
QC 기준을 충족하는 마지막 업데이트 제출
마지막으로 확인됨
추가 정보
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