Registry of Malignant Arrhythmias and Sudden Cardiac Death - Influence of Diagnostics and Interventions (RACE-IT)

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.

Study Overview

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

• Study Type: Observational
• Enrollment (Anticipated): 3200

Contacts and Locations

• Study Contact: Name: Ibrahim Akin, Prof. Dr.; Phone Number: +49 621 383 5229; Email: ibrahim.akin@umm.de
• Study Contact Backup: Name: Michael Behnes, Dr. med.; Phone Number: +49 621 383 6239; Email: michael.behnes@umm.de

Study Locations

• Germany
  • Mannheim, Germany, 68167
    • Recruiting
    • First Department of Medicine, University Medical Centre Mannheim
    • Contact: Ibrahim Akin, MD, PhD; Email: ibrahim.akin@umm.de
    • Contact: Michael Behnes, MD; Email: michael.behnes@umm.de

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• 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.

Description

Inclusion Criteria:

Hospitalization due to:

• ventricular tachycardia
• ventricular fibrillation
• sudden cardiac death

Exclusion Criteria:

• not diagnosed with one or more of the above

Study Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
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

Outcome Measure	Time Frame
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
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
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
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

Collaborators and Investigators

• Sponsor: Universitätsmedizin Mannheim
• Investigators: Principal Investigator: Ibrahim Akin, Prof. Dr., First Deparment of Medicine, University Medical Centre Mannheim (UMM), Germany; Theodor-Kutzer-Ufer 1-3; 61867 Mannheim, Germany

Publications and helpful links

General Publications

• 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.
• 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.
• 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.

Study record dates

Study Major Dates

• Study Start (Actual): April 1, 2016
• Primary Completion (Anticipated): December 1, 2021
• Study Completion (Anticipated): July 1, 2022

Study Registration Dates

• First Submitted: November 29, 2016
• First Submitted That Met QC Criteria: November 30, 2016
• First Posted (Estimate): December 5, 2016

Study Record Updates

• Last Update Posted (Actual): August 27, 2020
• Last Update Submitted That Met QC Criteria: August 26, 2020
• Last Verified: August 1, 2020

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Heart Diseases; Cardiovascular Diseases; Death, Sudden; Arrhythmias, Cardiac; Cardiac Conduction System Disease; Heart Arrest; Death; Ventricular Fibrillation; Tachycardia; Tachycardia, Ventricular; Death, Sudden, Cardiac
• Other Study ID Numbers: 2016-612N-MA

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO