Registry of Malignant Arrhythmias and Sudden Cardiac Death - Influence of Diagnostics and Interventions

• Conditions: Coronary Angiography; Sudden Cardiac Death; Ventricular Tachycardia; Ventricular Fibrillation; Internal Cardioverter Defibrillator (ICD); Electrophysiologic Testing (EP); Catheter Ablation; Percutaneous Coronary Intervention (PCI)

• Registration Number: NCT02982473
• Lead Sponsor: Universitätsmedizin Mannheim

Brief Summary

The "Registry of Malignant Arrhythmias and Sudden Cardiac Death - Influence of Diagnostics and Interventions (RACE-IT)" represents a mono-centric registry of patients being hospitalized suffering from malignant arrythmias (ventricular tachycardia or fibrillation) and sudden cardiac death (SCD).

Detailed findings of patients' clinical outcome regarding mortality and co-morbidities related to the presence of invasive diagnostics or therapies including coronary angiography, percutaneous coronary intervention (PCI), electrophysiological testing (EP), catheter ablation and implanted cardiac devices (e.g. implantable cardioverter-defibrillators) will be documented. Patients will be included when being hospitalized from the year 2004 until today.

Detailed Description

Not available

Study Timeline

• Study Start: 2016-04
• Study First Submitted: 2016-11-29
• Study First Submitted QC: 2016-11-30
• Study First Posted: 2016-12-05
• Status Verified: 2020-08
• Last Update Submitted: 2020-08-26
• Last Update Posted: 2020-08-27
• Primary Completion: 2021-12
• Study Completion: 2022-07

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 3200

Inclusion Criteria

Hospitalization due to:

• ventricular tachycardia
• ventricular fibrillation
• sudden cardiac death

Exclusion Criteria

• not diagnosed with one or more of the above

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Incidence of ventricular arrythmias (i.e. ventricular fibrillation, ventricular tachykardia, asystole, SCD)	Through study completion, potentially up to 12 years, depending on patient inclusion/first event and patients lifetime

Secondary Outcome Measures

Name	Time	Method
Incidence of coronary artery disease (CAD) and PCI in patients with VF/VT/SCD	Through study completion, potentially up to 12 years, depending on patient inclusion/first event and patients lifetime
Incidences of recurrent malignant tachycardias, all-cause mortality, arrhythmia-related death, re-PCI/ACVB, re-ablation, further therapy with cardiac devices	Through study completion, potentially up to 12 years, depending on patient inclusion/first event and patients lifetime
Incidence of treatment with cardiac devices (i.e. ICD, CCM, CRT-D)	Through study completion, potentially up to 12 years, depending on patient inclusion/first event and patients lifetime
Incidence of invasive electrophysiologic testing (EP) and catheter ablation	Through study completion, potentially up to 12 years, depending on patient inclusion/first event and patients lifetime

Trial Locations

Locations (1)

First Department of Medicine, University Medical Centre Mannheim; 🇩🇪 Mannheim, Germany