Ventricular TachycardiaRACE-ITNCT02982473
Registry of Malignant Arrhythmias and Sudden Cardiac Death - Influence of Diagnostics and Interventions
An observational study of Ventricular Tachycardia and Ventricular Fibrillation, run by Universitätsmedizin Mannheim at 1 site in Germany.
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). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Ventricular Tachycardia, Ventricular Fibrillation, Sudden Cardiac Death
- How many people
- 3,200 participants
- Where
- 1 siteGermany
- Study dates
- Apr 2016to Jul 2022
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
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.
Who may be able to join
- Hospitalization due to:
- ventricular tachycardia
- ventricular fibrillation
- sudden cardiac death
Who cannot join
- not diagnosed with one or more of the above
Trial locations and contacts
1 site in 1 country.
Germany1 site, 1 recruiting
- Recruiting
First Department of Medicine, University Medical Centre Mannheim
Mannheim, 68167
Ibrahim Akin, MD, PhD, ibrahim.akin@umm.de
Michael Behnes, MD, michael.behnes@umm.de
About this study
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
- Medical subject headings
- Tachycardia, Ventricular, Ventricular Fibrillation, Death, Sudden, Cardiac
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of ventricular arrythmias (i.e. ventricular fibrillation, ventricular tachykardia, asystole, SCD)
Measured: 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
Measured: 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
Measured: 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)
Measured: 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
Measured: Through study completion, potentially up to 12 years, depending on patient inclusion/first event and patients lifetime
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Dec 2016 (estimated)
- Study startApr 2016
- Primary completionDec 2021 (estimated)
- Study completionJul 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Ventricular TachycardiaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 3,200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Universitätsmedizin Mannheim
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Michael Behnes, Universitätsmedizin Mannheim
- Investigators
- Ibrahim Akin, Prof. Dr., Principal investigator, First Deparment of Medicine, University Medical Centre Mannheim (UMM), Germany; Theodor-Kutzer-Ufer 1-3; 61867 Mannheim, Germany
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02982473
- Sponsor's protocol ID
- 2016-612N-MA
- Acronym
- RACE-IT
- Status last verified
- Aug 2020
- First submitted
- 29 Nov 2016
- Last updated
- 27 Aug 2020
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
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.
PubMed 35361107Rusnak 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.
PubMed 31122256Schupp 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.
PubMed 30074111
Study at a glance
From the registry record, last updated by the sponsor on 27 Aug 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Registry of Malignant Arrhythmias and Sudden Cardiac Death - Influence of Diagnostics and Interventions
- ClinicalTrials.gov ID
- NCT02982473
- Acronym / sponsor ID
- RACE-IT / 2016-612N-MA
- Conditions
- Ventricular Tachycardia, Ventricular Fibrillation, Sudden Cardiac Death, Coronary Angiography, Electrophysiologic Testing (EP), Catheter Ablation
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 3,200 participants (estimated)
- Lead sponsor
- Universitätsmedizin MannheimUniversity, hospital or other
- Study start
- Apr 2016 (actual)
- Primary completion
- Dec 2021 (estimated)
- Study completion
- Jul 2022 (estimated)
- First posted
- 5 Dec 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Retrospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (4 listed)
- ventricular tachycardia
- ventricular fibrillation
- sudden cardiac death
Key exclusion criteria (1 listed)
- not diagnosed with one or more of the above
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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
4 secondary outcomes
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
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
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
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
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Aug 2020.
- Derived from this study: PubMed 35361107Weidner 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.
- Derived from this study: PubMed 31122256Rusnak 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.
- Derived from this study: PubMed 30074111Schupp 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.
- Individual participant dataSharing planned: No
Related trials for Ventricular Tachycardia
Enrolling by invitation
VINTAGE (Ventricular Intramyocardial Navigation for Tachycardia Ablation Guided by Electrograms) Using Commercial Off-The-Shelf (COTS) Catheters
Ventricular Arrhythmia
Active, not recruiting
Assessment of Combined CCM and ICD Device in HFrEF
Heart Failure, Heart Failure With Reduced Ejection Fraction
Recruiting
A Study Assessing Arrhythmia Mapping With a Multi-Electrode Mapping Catheter
Scar-related Atrial Tachycardia, Persistent Atrial Fibrillation
RecruitingObservational study
Genetic Markers of Cardiovascular Disease in Epilepsy
Epilepsy, Seizures
Recruiting
Cardiac RADIoablation Versus Repeat Catheter Ablation: a Pivotal Randomized Clinical Trial Evaluating Safety and Efficacy for Patients With High-risk Refractory Ventricular Tachycardia (RADIATE-VT)
Tachycardia, Ventricular
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Ibrahim Akin, Prof. Dr. principal investigator
First Deparment of Medicine, University Medical Centre Mannheim (UMM), Germany; Theodor-Kutzer-Ufer 1-3; 61867 Mannheim, Germany
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Ventricular Tachycardia and Ventricular Fibrillation, run by Universitätsmedizin Mannheim at 1 site in Germany.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 27 Aug 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Ibrahim Akin, Prof. Dr. (+49 621 383 5229, ibrahim.akin@umm.de), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02982473, which also lists 3 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Aug 2020.