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

NCT02982473 | Unknown

• 1 other identifier: 2016-612N-MA
• Study Type: observational
• Target: 3,200
• Locations: 1 country
• Sites: 1

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.

Conditions

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

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (4)

• 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

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

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

You may not qualify if:

• not diagnosed with one or more of the above

Sponsors & Collaborators

• Universitätsmedizin Mannheim: lead

Study Sites (1)

First Department of Medicine, University Medical Centre Mannheim

Mannheim, 68167, Germany

RECRUITING

Related Publications (3)

• 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.

  PMID: 35361107 DERIVED

• 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.

  PMID: 31122256 DERIVED

• 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.

  PMID: 30074111 DERIVED

MeSH Terms

Conditions

Tachycardia, Ventricular; Ventricular Fibrillation; Death, Sudden, Cardiac

Condition Hierarchy (Ancestors)

Tachycardia; Arrhythmias, Cardiac; Heart Diseases; Cardiovascular Diseases; Cardiac Conduction System Disease; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Heart Arrest; Death, Sudden; Death

Study Officials

• Ibrahim Akin, Prof. Dr.

  First Deparment of Medicine, University Medical Centre Mannheim (UMM), Germany; Theodor-Kutzer-Ufer 1-3; 61867 Mannheim, Germany

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Ibrahim Akin, Prof. Dr.

CONTACT

+49 621 383 5229; ibrahim.akin@umm.de

Michael Behnes, Dr. med.

CONTACT

+49 621 383 6239; michael.behnes@umm.de

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Sub-PI

Study Record Dates

• First Submitted: November 29, 2016
• First Posted: December 5, 2016
• Study Start: April 1, 2016
• Primary Completion: December 1, 2021
• Study Completion: July 1, 2022
• Last Updated: August 27, 2020

Record last verified: 2020-08

Data Sharing

• IPD Sharing: Will not share

Locations

DE (1)