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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.

Tracking Information
First Submitted Date February 18, 2009
First Posted Date February 19, 2009
Last Update Posted Date February 4, 2010
Study Start Date February 2009
Estimated Primary Completion Date February 2010   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: February 18, 2009)
Normal values for depolarization characteristics will be established for study groups [ Time Frame: end of data collection ]
Original Primary Outcome Measures Same as current
Change History Complete list of historical versions of study NCT00847353 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures Not Provided
Original Secondary Outcome Measures Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title Normal Values of High Frequency ECG (HyperQ™) in Apparently Healthy Individuals and in Young and Masters Athletes
Official Title Normal Values of High Frequency ECG (HyperQ™) in Asymptomatic, Apparently Healthy Normal Weight vs. Obese Individuals and in Young and Masters Athletes
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.
Detailed Description Not Provided
Study Type Observational
Study Design Time Perspective: Prospective
Target Follow-Up Duration Not Provided
Biospecimen Not Provided
Sampling Method Non-Probability Sample
Study Population community sample referred or self referred to stress testing
Condition
  • Healthy
  • Asymptomatic
  • Obesity
Intervention Not Provided
Study Groups/Cohorts Not Provided
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Unknown status
Estimated Enrollment
 (submitted: February 18, 2009)
300
Original Estimated Enrollment Same as current
Estimated Study Completion Date June 2010
Estimated Primary Completion Date February 2010   (Final data collection date for primary outcome measure)
Eligibility 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
Sex/Gender
Sexes Eligible for Study: All
Ages 18 Years to 65 Years   (Adult, Older Adult)
Accepts Healthy Volunteers Yes
Contacts Contact information is only displayed when the study is recruiting subjects
Listed Location Countries Israel
Removed Location Countries  
 
Administrative Information
NCT Number NCT00847353
Other Study ID Numbers WIN_01
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement Not Provided
Responsible Party Prinicipal Investigator, The Ribstein Center for Sports Medicine and Research, Wingate
Study Sponsor BSP Biological Signal Processing Ltd.
Collaborators Not Provided
Investigators Not Provided
PRS Account BSP Biological Signal Processing Ltd.
Verification Date February 2010