Athlete's HeartNCT00634335
Echocardiographic Characteristics of High Endurance Israeli Athletes
An observational study of Athlete's Heart, run by Soroka University Medical Center at 1 site in Israel.
Trial summary
The purpose of this study is to characterize the cardiac adaptive changes of professional Israeli bicyclists by using echocardiography. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Athlete's Heart
- How many people
- 81 participants
- Where
- 1 siteIsrael
- Study dates
- Mar 2008to Jun 2009
- 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
- Healthy volunteers accepted
- Adult, Older adult
Study population: professional bicyclists in Israel
Who may be able to join
- Known athletes of the bicyclists organization of Israel or any other known organization for 2 year at least.
- Participated in at least one contest recognized by the bicyclists organization of Israel.
- Had been in training for the last 3 months at least, which included minimum of 8 hours a week in average
Who cannot join
- Do not suffer any known cardiac disease
- Had declared that they are not using drugs which are forbidden by the Olympic committee
Trial locations and contacts
1 site in 1 country.
Israel1 site, 1 recruiting
- Recruiting
Soroka University Medical Center
Beersheba
KOBAL SERGIO, MD, 972-8-6400133, kobal@bgu.ac.il
SERGIO KOBAL, MD
About this study
The purpose of this study is to characterize the cardiac adaptive changes of professional Israeli bicyclists by using echocardiography.
Read the detailed description
Adaptive cardiac changes, such as enlargement of left ventricle mass and enlargement of left ventricular wall was observed in athletes. The physiological limit of remodeling changes in accordance to sex, type of activity, intensity of activity, genetics and race.
Although many studies were conducted on this subject, it is still impossible to predict if an athlete from a certain sport will develop cardiac changes and their what will those changes characteristics will be.
Sudden cardiac death is the leading cause of death among young athletes, this is because of high physical activity in the presence of a hidden heart disease, therefore there is much debate about the needed screening tests for athletes.
In Israel, there is only one study in this subject that showed no significant cardiac changes in Olympic athletes of various types of sports. the study didn't focused on high endurance sport athletes such as professional bicyclists although cardiac endurance is a main factor in cardiac changes.
- Conditions
- Athlete's Heart
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| sk | professional Israeli bicyclists |
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Mar 2008 (estimated)
- Study startMar 2008
- Primary completionMar 2009 (estimated)
- Study completionJun 2009 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Athlete's HeartStudies 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
- Cross-sectional
- Enrolment
- 81 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Soroka University Medical Center
- Sponsor type
- University, hospital or other
- Investigators
- Sergio Kobal, MD, Principal investigator, Soroka medical center, Israel
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00634335
- Sponsor's protocol ID
- sor465808ctil
- Status last verified
- Feb 2008
- First submitted
- 4 Mar 2008
- Last updated
- 30 Dec 2008
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 30 Dec 2008. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Echocardiographic Characteristics of High Endurance Israeli Athletes
- ClinicalTrials.gov ID
- NCT00634335
- Acronym / sponsor ID
- sor465808ctil
- Conditions
- Athlete's Heart
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 81 participants (estimated)
- Lead sponsor
- Soroka University Medical CenterUniversity, hospital or other
- Study start
- Mar 2008
- Primary completion
- Mar 2009 (estimated)
- Study completion
- Jun 2009 (estimated)
- First posted
- 13 Mar 2008 (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 purpose of this study is to characterize the cardiac adaptive changes of professional Israeli bicyclists by using echocardiography.
Detailed description
Adaptive cardiac changes, such as enlargement of left ventricle mass and enlargement of left ventricular wall was observed in athletes. The physiological limit of remodeling changes in accordance to sex, type of activity, intensity of activity, genetics and race.
Although many studies were conducted on this subject, it is still impossible to predict if an athlete from a certain sport will develop cardiac changes and their what will those changes characteristics will be.
Sudden cardiac death is the leading cause of death among young athletes, this is because of high physical activity in the presence of a hidden heart disease, therefore there is much debate about the needed screening tests for athletes.
In Israel, there is only one study in this subject that showed no significant cardiac changes in Olympic athletes of various types of sports. the study didn't focused on high endurance sport athletes such as professional bicyclists although cardiac endurance is a main factor in cardiac changes.
Study design
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| sk | – | –professional Israeli bicyclists |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- professional bicyclists in Israel
Key inclusion criteria (3 listed)
- Known athletes of the bicyclists organization of Israel or any other known organization for 2 year at least.
- Participated in at least one contest recognized by the bicyclists organization of Israel.
- Had been in training for the last 3 months at least, which included minimum of 8 hours a week in average
Key exclusion criteria (2 listed)
- Do not suffer any known cardiac disease
- Had declared that they are not using drugs which are forbidden by the Olympic committee
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
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 30 Dec 2008.
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Hypertrophic Cardiomyopathy
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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.
Sergio Kobal, MD principal investigator
Soroka medical center, Israel
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 Athlete's Heart, run by Soroka University 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 2 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 30 Dec 2008. 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 Sergio Kobal, MD (972-8-6400133, kobal@bgu.ac.il), 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 30 Dec 2008.