arrhythmia risk stratification
Conditions
Interventions
None listed
Sponsors
Academisch Medisch Centrum
Eligibility
Age
18 Years to 99 Years
Inclusion criteria
Inclusion criteria: - Clinical indication (primary and secondary prevention of SCD) for ICD implantation/ICD exchange or chronically implanted ICD - Age > 18 years - Written informed consent - Negative pregnancy test in women of childbearing potential - No participation in other clinical trials within one month before and after enrolment into the study;- Cardiac resynchronisation therapy (CRT) devices are excluded from the study (for their special effects in reversal of repolarisation remodeling) for at least 6 months after implantation, thereafter single- and dual-chamber devices are still to be preferred. Single and dual-chamber device exhange patients recruited to the invasive studies must not have RV pacing > 20% of the time. - Up to 60% of all patients with coronary artery disease, with or without a history of myocardial infarction (occurrence of STEMI, NSTEMI and highest CKmax will be recorded). This will be monitored by Dr. Eva Müller from the clinical IFS institute in G*ttingen. - Up to 350 patients with non-ischemic cardiomyopathies (180 dilated cardiomyopathy [DCM], 70 hypertrophic cardiomyopathy [HCM] / hypertrophic obstructive cardiomyopathy [HOCM], 20 arrhythmogenic right ventricular cardiomyopathy [ARVC], channelopathies (30 Brugada syndrome, 20 long QT syndrome, 10 catecholaminergic polymorphic ventricular tachycardia [CPVT]) or idiopathic VT/VF (n=20) with any LV ejection fraction. This will be monitored by Dr. Eva Müller from the clinical IFS institute in G*ttingen.
Exclusion criteria
Exclusion criteria: - Unstable cardiac disease such as decompensated heart failure (NYHA class IV) or acute coronary syndrome or symptomatic arrhythmias - Percutaneous coronary intervention (PCI) or coronary artery bypass graft (CABG) surgery less than 3 months ago - ICDs unable to deliver programmed ventricular stimulation via programmer (in the chronic ICD group) - Permanent atrial fibrillation if more than 20% of all patients at a given time during the study are enrolled, this condition will be flagged by the study manager Dr. Eva Müller from the clinical IFS institute in G*ttingen which also runs the secure clinical database.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 1. target genes/cardiac: SCN5A, SCN1B, PLN, HRC, HSP20, NCX, CSQ, HAX-1, JCN, RyR, Dystrophin, Troponin, KCNQ1, KCNH2, ANK2, DRB1 (19 genes). Metabolic/diabetes: INS + INS receptor (two genes). Metabolic/obesity: MC4R (one gene). Analysis of new unknown genes is possible. 2. digital resting ECG 3. signal averaging ECG 4. T-wave-alternans-test 5. electrophysiological study 6. 24h ECG | — |
Countries
Netherlands
Outcome results
None listed