Clinical trial NCT02982473: Registry of Malignant Arrhythmias and Sudden Cardiac Death - Influence of Diagnostics and Interventions
Official title: Registry of Malignant Arrhythmias and Sudden Cardiac Death - Influence of Diagnostics and Interventions
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Ventricular Tachycardia
Ventricular Fibrillation
Sudden Cardiac Death
Coronary Angiography
Electrophysiologic Testing (EP)
Catheter Ablation
Percutaneous Coronary Intervention (PCI)
Internal Cardioverter Defibrillator (ICD)
Lead sponsor: Universitätsmedizin Mannheim
Sponsor class: OTHER
First posted: 2016-12-05
Enrollment: 3200
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients being hospitalized with diagnoses of ventricular tachycardia, ventricular fibrillation and/or sudden cardiac death at the First Department of Medicine, University Medical Centre Mannheim, Germany.

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.


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

Primary outcomes:
measure: Incidence of ventricular arrythmias (i.e. ventricular fibrillation, ventricular tachykardia, asystole, SCD)
timeFrame: Through study completion, potentially up to 12 years, depending on patient inclusion/first event and patients lifetime
Secondary outcomes:
measure: Incidence of coronary artery disease (CAD) and PCI in patients with VF/VT/SCD
timeFrame: Through study completion, potentially up to 12 years, depending on patient inclusion/first event and patients lifetime
measure: Incidence of invasive electrophysiologic testing (EP) and catheter ablation
timeFrame: Through study completion, potentially up to 12 years, depending on patient inclusion/first event and patients lifetime
measure: Incidence of treatment with cardiac devices (i.e. ICD, CCM, CRT-D)
timeFrame: Through study completion, potentially up to 12 years, depending on patient inclusion/first event and patients lifetime
measure: Incidences of recurrent malignant tachycardias, all-cause mortality, arrhythmia-related death, re-PCI/ACVB, re-ablation, further therapy with cardiac devices
timeFrame: Through study completion, potentially up to 12 years, depending on patient inclusion/first event and patients lifetime
Other outcomes:
Locations:
city: Mannheim
country: Germany
facility: First Department of Medicine, University Medical Centre Mannheim
Study officials:
affiliation: First Deparment of Medicine, University Medical Centre Mannheim (UMM), Germany; Theodor-Kutzer-Ufer 1-3; 61867 Mannheim, Germany
name: Ibrahim Akin, Prof. Dr.
role: PRINCIPAL_INVESTIGATOR
References:
citation: Weidner K, Behnes M, Schupp T, Hoppner J, El-Battrawy I, Ansari U, Saleh A, Taton G, Reiser L, Bollow A, Reichelt T, Ellguth D, Engelke N, Bertsch T, Grosse Meininghaus D, Hoffmann U, Akin I. Cardiac disease and prognosis associated with ventricular tachyarrhythmias in young adults and adults. BMC Cardiovasc Disord. 2022 Mar 31;22(1):136. doi: 10.1186/s12872-022-02552-6.
citation: Rusnak J, Behnes M, Schupp T, Lang S, Reiser L, Taton G, Bollow A, Reichelt T, Ellguth D, Engelke N, Ansari U, El-Battrawy I, Bertsch T, Nienaber CA, Akin M, Mashayekhi K, Weiss C, Borggrefe M, Akin I. Statin therapy is associated with improved survival in patients with ventricular tachyarrhythmias. Lipids Health Dis. 2019 May 24;18(1):119. doi: 10.1186/s12944-019-1011-x.
citation: Schupp T, Behnes M, Weiss C, Nienaber C, Lang S, Reiser L, Bollow A, Taton G, Reichelt T, Ellguth D, Engelke N, Ansari U, El-Battrawy I, Bertsch T, Akin M, Mashayekhi K, Borggrefe M, Akin I. Beta-Blockers and ACE Inhibitors Are Associated with Improved Survival Secondary to Ventricular Tachyarrhythmia. Cardiovasc Drugs Ther. 2018 Aug;32(4):353-363. doi: 10.1007/s10557-018-6812-z.