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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT02982473
Other study ID # 2016-612N-MA
Secondary ID
Status Recruiting
Phase
First received
Last updated
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
Health authority
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

Study Design


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
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