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

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ClinicalTrials.gov Identifier: NCT02982473
Recruitment Status : Unknown
Verified November 2016 by Michael Behnes, Universitätsmedizin Mannheim.
Recruitment status was:  Recruiting
First Posted : December 5, 2016
Last Update Posted : December 5, 2016
Sponsor:
Information provided by (Responsible Party):
Michael Behnes, Universitätsmedizin Mannheim

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.


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

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Study Type : Observational
Estimated Enrollment : 3200 participants
Observational Model: Cohort
Time Perspective: Retrospective
Official Title: Registry of Malignant Arrhythmias and Sudden Cardiac Death - Influence of Diagnostics and Interventions
Study Start Date : April 2016
Estimated Primary Completion Date : January 2017
Estimated Study Completion Date : July 2017

Resource links provided by the National Library of Medicine





Primary Outcome Measures :
  1. Incidence of ventricular arrythmias (i.e. ventricular fibrillation, ventricular tachykardia, asystole, SCD) [ Time Frame: Through study completion, potentially up to 12 years, depending on patient inclusion/first event and patients lifetime ]

Secondary Outcome Measures :
  1. Incidence of coronary artery disease (CAD) and PCI in patients with VF/VT/SCD [ Time Frame: Through study completion, potentially up to 12 years, depending on patient inclusion/first event and patients lifetime ]
  2. Incidence of invasive electrophysiologic testing (EP) and catheter ablation [ Time Frame: Through study completion, potentially up to 12 years, depending on patient inclusion/first event and patients lifetime ]
  3. Incidence of treatment with cardiac devices (i.e. ICD, CCM, CRT-D) [ Time Frame: Through study completion, potentially up to 12 years, depending on patient inclusion/first event and patients lifetime ]
  4. Incidences of recurrent malignant tachycardias, all-cause mortality, arrhythmia-related death, re-PCI/ACVB, re-ablation, further therapy with cardiac devices [ Time Frame: Through study completion, potentially up to 12 years, depending on patient inclusion/first event and patients lifetime ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.
Criteria

Inclusion Criteria:

Hospitalization due to:

  • ventricular tachycardia
  • ventricular fibrillation
  • sudden cardiac death

Exclusion Criteria:

  • not diagnosed with one or more of the above

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02982473


Contacts
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Contact: Ibrahim Akin, Prof. Dr. +49 621 383 5229 ibrahim.akin@umm.de
Contact: Michael Behnes, Dr. med. +49 621 383 6239 michael.behnes@umm.de

Locations
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Germany
First Department of Medicine, University Medical Centre Mannheim Recruiting
Mannheim, Germany, 68167
Contact: Ibrahim Akin, MD, PhD       ibrahim.akin@umm.de   
Contact: Michael Behnes, MD       michael.behnes@umm.de   
Sponsors and Collaborators
Universitätsmedizin Mannheim
Investigators
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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 automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Michael Behnes, Sub-PI, Universitätsmedizin Mannheim
ClinicalTrials.gov Identifier: NCT02982473     History of Changes
Other Study ID Numbers: 2016-612N-MA
First Posted: December 5, 2016    Key Record Dates
Last Update Posted: December 5, 2016
Last Verified: November 2016
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Additional relevant MeSH terms:
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Tachycardia
Tachycardia, Ventricular
Death, Sudden, Cardiac
Ventricular Fibrillation
Death
Pathologic Processes
Arrhythmias, Cardiac
Heart Diseases
Cardiovascular Diseases
Cardiac Conduction System Disease
Heart Arrest
Death, Sudden