Arrhythmia Risk Stratification in a Clinical Patient Cohort and Correlation with Genotype and Environmental Modulators

Completed

• Conditions: arrhythmia risk stratification; 10007521; 10007510

• Registration Number: NL-OMON37942
• Lead Sponsor: Academisch Medisch Centrum

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Last Update Posted: 6 May 2024

Recruitment & Eligibility

• Status: Completed
• Sex: Not specified
• Target Recruitment: 100

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

- 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.

Study & Design

• Study Type: Observational invasive
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>1. target genes/cardiac: SCN5A, SCN1B, PLN, HRC, HSP20, NCX, CSQ, HAX-1, JCN,<br /><br>RyR, Dystrophin, Troponin, KCNQ1, KCNH2, ANK2, DRB1 (19 genes).<br /><br>Metabolic/diabetes: INS + INS receptor (two genes). Metabolic/obesity: MC4R<br /><br>(one gene). Analysis of new unknown genes is possible.<br /><br>2. digital resting ECG<br /><br>3. signal averaging ECG<br /><br>4. T-wave-alternans-test<br /><br>5. electrophysiological study<br /><br>6. 24h ECG</p><br>

Secondary Outcome Measures

Name	Time	Method
<p>NA</p><br>