HealthyNCT00847353
Normal Values of High Frequency ECG (HyperQ™) in Apparently Healthy Individuals and in Young and Masters Athletes
An observational study of Healthy and Asymptomatic, run by BSP Biological Signal Processing Ltd. at 1 site in Israel.
Trial summary
The main objective of this study is to investigate depolarization characteristics represented by changes in HyperQ in asymptomatic, apparently healthy athletic and non-athletic individuals. We also aim to examine a subgroup of obese and non-obese subjects. Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy, Asymptomatic, Obesity
- How many people
- 300 participants
- Where
- 1 siteIsrael
- Study dates
- Feb 2009to Jun 2010
- 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 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: community sample referred or self referred to stress testing
Who may be able to join
- An asymptomatic, apparently healthy patient performing a maximal exercise stress test
Who cannot join
- Contraindications for an exercise test
- Wolff-Parkinson-White (pre-excitation) syndrome
- Atrial Fibrillation or significant ventricular arrhythmia
- Treatment with Digoxin
- Pacemaker
- Pregnancy or suspected pregnancy
- QRS duration>120ms or other conduction delays
Trial locations and contacts
1 site in 1 country.
• Irena Imanuel, MD contact
Israel1 site, 1 recruiting
- Recruiting
The Ribstein Center for Sports Medicine and Research
Netanya
Eyal Shargal, PhD, eyal@wingate.org
Dr Irena Imanuel, MD
About this study
Official title: Normal Values of High Frequency ECG (HyperQ™) in Asymptomatic, Apparently Healthy Normal Weight vs. Obese Individuals and in Young and Masters Athletes
The main objective of this study is to investigate depolarization characteristics represented by changes in HyperQ in asymptomatic, apparently healthy athletic and non-athletic individuals. We also aim to examine a subgroup of obese and non-obese subjects. The goal of the study is to establish normal HyperQ values in these populations and compare HyperQ values of age-matched athletic vs. non-athletic individuals of similar health status.
- Conditions
- Healthy, Asymptomatic, Obesity
- Keywords
- high frequency ECG, normal values, asymptomatic, obese
- Medical subject headings
- Obesity
What is being measured
The primary outcome is the main question the study is designed to answer.
Normal values for depolarization characteristics will be established for study groups
Measured: end of data collection
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Feb 2009 (estimated)
- Study startFeb 2009
- Primary completionFeb 2010 (estimated)
- Study completionJun 2010 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HealthyStudies 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
- Time perspective
- Prospective
- Enrolment
- 300 participants (estimated)
Sponsor and investigators
- Lead sponsor
- BSP Biological Signal Processing Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00847353
- Sponsor's protocol ID
- WIN_01
- Status last verified
- Feb 2010
- First submitted
- 18 Feb 2009
- Last updated
- 4 Feb 2010
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 Feb 2010. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Normal Values of High Frequency ECG (HyperQ™) in Asymptomatic, Apparently Healthy Normal Weight vs. Obese Individuals and in Young and Masters Athletes
- ClinicalTrials.gov ID
- NCT00847353
- Acronym / sponsor ID
- WIN_01
- Conditions
- Healthy, Asymptomatic, Obesity
- Keywords
- high frequency ECG, normal values, asymptomatic, obese
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 300 participants (estimated)
- Lead sponsor
- BSP Biological Signal Processing Ltd.Industry (pharma, biotech, devices)
- Study start
- Feb 2009
- Primary completion
- Feb 2010 (estimated)
- Study completion
- Jun 2010 (estimated)
- First posted
- 19 Feb 2009 (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 main objective of this study is to investigate depolarization characteristics represented by changes in HyperQ in asymptomatic, apparently healthy athletic and non-athletic individuals. We also aim to examine a subgroup of obese and non-obese subjects. The goal of the study is to establish normal HyperQ values in these populations and compare HyperQ values of age-matched athletic vs. non-athletic individuals of similar health status.
Study design
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- community sample referred or self referred to stress testing
Key inclusion criteria (1 listed)
- An asymptomatic, apparently healthy patient performing a maximal exercise stress test
Key exclusion criteria (7 listed)
- Contraindications for an exercise test
- Wolff-Parkinson-White (pre-excitation) syndrome
- Atrial Fibrillation or significant ventricular arrhythmia
- Treatment with Digoxin
- Pacemaker
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
Normal values for depolarization characteristics will be established for study groups
Time frame: end of data collection
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Feb 2010.
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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.
• Irena Imanuel, MD contact
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 Healthy and Asymptomatic, run by BSP Biological Signal Processing Ltd. 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 1 inclusion and 7 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 4 Feb 2010. 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 • Irena Imanuel, MD (09-8639420), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Normal values for depolarization characteristics will be established for study groups (time frame: end of data collection). It is what the study was designed to measure, not a finding.
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 4 Feb 2010.