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Clinical Trials/NCT02982473
NCT02982473
Unknown
Not Applicable

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

Universitätsmedizin Mannheim1 site in 1 country3,200 target enrollmentApril 2016

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Ventricular Tachycardia
Sponsor
Universitätsmedizin Mannheim
Enrollment
3200
Locations
1
Primary Endpoint
Incidence of ventricular arrythmias (i.e. ventricular fibrillation, ventricular tachykardia, asystole, SCD)
Last Updated
5 years ago

Overview

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.

Registry
clinicaltrials.gov
Start Date
April 2016
End Date
July 2022
Last Updated
5 years ago
Study Type
Observational
Sex
All

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Michael Behnes

Sub-PI

Universitätsmedizin Mannheim

Eligibility Criteria

Inclusion Criteria

  • Hospitalization due to:
  • ventricular tachycardia
  • ventricular fibrillation
  • sudden cardiac death

Exclusion Criteria

  • not diagnosed with one or more of the above

Outcomes

Primary Outcomes

Incidence of ventricular arrythmias (i.e. ventricular fibrillation, ventricular tachykardia, asystole, SCD)

Time Frame: Through study completion, potentially up to 12 years, depending on patient inclusion/first event and patients lifetime

Secondary Outcomes

  • 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)

Study Sites (1)

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