Sudden DeathAthleteNCT00469794
The Significance of Arrhythmias in Athletes
An observational study of Sudden Death, run by Assaf-Harofeh Medical Center at 1 site in Israel.
Trial summary
Athletes with complex ventricular arrhythmias are potentially at risk of sudden death. The aim of the study is to investigate the relevance of ventricular tachyarrhythmias induced by an exercise test in a retrospectively evaluated athletic population. Read more about this study
- Who is it for?
- Ages 10 to 35 years
- Conditions the study is for
- Sudden Death
- What is being tested?
- stress test
- Type of treatment
- Surgery or procedure
- How many people
- 300 participants
- Where
- 1 siteIsrael
- Study dates
- May 2006to May 2008
- 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 10 to 35 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- Competitive athletes less than 35 YO
- Competitive athletes with ventricular arrhythmias on baseline or recovery in a stress test
- Competitive athletes with ventricular arrhythmia during exercise
Who cannot join
- Athletes who don't meet the exclusion criteria.
Trial locations and contacts
1 site in 1 country.
Israel1 site, 1 recruiting
- Recruiting
Wingate Institute
Netanya
Therese Fuchs, MD, 972-8-977-9730, therese@fuchs.org
Rutie Plitz-Burstein, Ph.D.
About this study
Official title: The Long Term Significance of Exercise Induced Ventricular Arrhythmias in Trained Athletes
Athletes with complex ventricular arrhythmias are potentially at risk of sudden death. The aim of the study is to investigate the relevance of ventricular tachyarrhythmias induced by an exercise test in a retrospectively evaluated athletic population.
Read the detailed description
Athletes with complex ventricular arrhythmias are potentially at risk of sudden death. The risk is increased when the athletes are engaged in competitive activities.
Ventricular premature beats (VPB's) are a common finding in the athletic heart. In the majority of cases these arrhythmias are part of the "athlete's heart syndrome" and do not increase the risk of sudden death in the athletes with an apparently normal heart. The data available in the literature deal with ventricular arrhythmias assessed only by 24-h ambulatory electrocardiograms.
To date, there are no guidelines concerning athletes who develop ventricular arrhythmias during a stress test. It is unclear whether they should be allowed to continue with their competitive activity or they should be denied to do so. A study looking at the long term follow-up of these athletes will help us determine whether the development of ventricular arrhythmia during a stress test imposes any risk on the athletes.
- Conditions
- Sudden Death
- Being tested
- stress test
- Keywords
- arrhythmias, Athletes, exercise
- Medical subject headings
- Death, Sudden, Arrhythmias, Cardiac, Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
stress testProcedure or surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 May 2007 (estimated)
- Study startMay 2006
- Study completionMay 2008 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Sudden DeathStudies 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
- Case-control
- Time perspective
- Retrospective
- Enrolment
- 300 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Assaf-Harofeh Medical Center
- Sponsor type
- Other government
- Collaborators
- Institute of Physical Education and Sports Sciences
- Investigators
- Therese Fuchs, MD, Principal investigator, Assaf-Harofeh Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00469794
- Sponsor's protocol ID
- 50/06
- Acronym
- Athlete
- Status last verified
- May 2007
- First submitted
- 4 May 2007
- Last updated
- 7 May 2007
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 May 2007. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Long Term Significance of Exercise Induced Ventricular Arrhythmias in Trained Athletes
- ClinicalTrials.gov ID
- NCT00469794
- Acronym / sponsor ID
- Athlete / 50/06
- Conditions
- Sudden Death
- Keywords
- arrhythmias, Athletes, exercise
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 300 participants (estimated)
- Lead sponsor
- Assaf-Harofeh Medical CenterOther government
- Collaborators
- Institute of Physical Education and Sports Sciences
- Study start
- May 2006
- Study completion
- May 2008 (estimated)
- First posted
- 7 May 2007 (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.
Athletes with complex ventricular arrhythmias are potentially at risk of sudden death. The aim of the study is to investigate the relevance of ventricular tachyarrhythmias induced by an exercise test in a retrospectively evaluated athletic population.
Detailed description
Athletes with complex ventricular arrhythmias are potentially at risk of sudden death. The risk is increased when the athletes are engaged in competitive activities.
Ventricular premature beats (VPB's) are a common finding in the athletic heart. In the majority of cases these arrhythmias are part of the "athlete's heart syndrome" and do not increase the risk of sudden death in the athletes with an apparently normal heart. The data available in the literature deal with ventricular arrhythmias assessed only by 24-h ambulatory electrocardiograms.
To date, there are no guidelines concerning athletes who develop ventricular arrhythmias during a stress test. It is unclear whether they should be allowed to continue with their competitive activity or they should be denied to do so. A study looking at the long term follow-up of these athletes will help us determine whether the development of ventricular arrhythmia during a stress test imposes any risk on the athletes.
Study design
- Observational model
- Case-control
- Time perspective
- Retrospective
Who may qualify
- Ages
- 10 to 35 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (3 listed)
- Competitive athletes less than 35 YO
- Competitive athletes with ventricular arrhythmias on baseline or recovery in a stress test
- Competitive athletes with ventricular arrhythmia during exercise
Key exclusion criteria (1 listed)
- Athletes who don't meet the exclusion criteria.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| stress test | Procedure or surgery | – |
Primary outcome
Not reported in the source record.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 May 2007.
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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.
Therese Fuchs, MD principal investigator
Assaf-Harofeh Medical Center
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 Sudden Death, run by Assaf-Harofeh Medical Center at 1 site in Israel.
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 3 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 7 May 2007. 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 Israel. 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 Therese Fuchs, MD (972-8-977-9730, therese@fuchs.org), or a site near the patient. AzTrials does not enrol participants or take referrals.
Where can I read the original study information?
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 7 May 2007.