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Normal Values of High Frequency ECG (HyperQ™) in Apparently Healthy Individuals and in Young and Masters Athletes

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ClinicalTrials.gov Identifier: NCT00847353
Recruitment Status : Unknown
Verified February 2010 by BSP Biological Signal Processing Ltd..
Recruitment status was:  Recruiting
First Posted : February 19, 2009
Last Update Posted : February 4, 2010
Sponsor:
Information provided by:
BSP Biological Signal Processing Ltd.

Brief 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. 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.

Condition or disease
Healthy Asymptomatic Obesity

Study Type : Observational
Estimated Enrollment : 300 participants
Time Perspective: Prospective
Official Title: Normal Values of High Frequency ECG (HyperQ™) in Asymptomatic, Apparently Healthy Normal Weight vs. Obese Individuals and in Young and Masters Athletes
Study Start Date : February 2009
Estimated Primary Completion Date : February 2010
Estimated Study Completion Date : June 2010



Primary Outcome Measures :
  1. Normal values for depolarization characteristics will be established for study groups [ Time Frame: end of data collection ]


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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population
community sample referred or self referred to stress testing
Criteria

Inclusion Criteria:

  • An asymptomatic, apparently healthy patient performing a maximal exercise stress test

Exclusion Criteria:

  • 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

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): NCT00847353


Contacts
Contact: • Irena Imanuel, MD 09-8639420
Contact: Eyal Shargal, PhD 09-8639420 Eyal@wingate.org

Locations
Israel
The Ribstein Center for Sports Medicine and Research Recruiting
Netanya, Israel
Contact: Eyal Shargal, PhD       eyal@wingate.org   
Principal Investigator: Dr Irena Imanuel, MD         
Sub-Investigator: Rutie Pilz-Burstein, PhD         
Sponsors and Collaborators
BSP Biological Signal Processing Ltd.

Responsible Party: Prinicipal Investigator, The Ribstein Center for Sports Medicine and Research, Wingate
ClinicalTrials.gov Identifier: NCT00847353     History of Changes
Other Study ID Numbers: WIN_01
First Posted: February 19, 2009    Key Record Dates
Last Update Posted: February 4, 2010
Last Verified: February 2010

Keywords provided by BSP Biological Signal Processing Ltd.:
high frequency ECG
normal values
asymptomatic
obese