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

Ventricular Tachycardia Clinical Trial

— RACE-IT  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02982473
• Other study ID #: 2016-612N-MA
• Status: Recruiting
• Start date: April 2016
• Est. completion date: July 2022

Study information

• Verified date: August 2020
• Source: Universitätsmedizin Mannheim
• Contact: Ibrahim Akin, Prof. Dr.
• Phone: +49 621 383 5229
• Email: ibrahim.akin[@]umm.de
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 3200
• Est. completion date: July 2022
• Est. primary completion date: December 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

Hospitalization due to:

• ventricular tachycardia

• ventricular fibrillation

• sudden cardiac death

Exclusion Criteria:

• not diagnosed with one or more of the above

Related Conditions & MeSH terms

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

Locations

Country	Name	City	State
Germany	First Department of Medicine, University Medical Centre Mannheim	Mannheim

Sponsors (1)

Lead Sponsor	Collaborator
Universitätsmedizin Mannheim

Country where clinical trial is conducted

Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	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
Secondary	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
Secondary	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