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NCT00847353 Clinical Trial

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

Healthy Clinical Trial

Official title:
Normal Values of High Frequency ECG (HyperQ™) in Asymptomatic, Apparently Healthy Normal Weight vs. Obese Individuals and in Young and Masters Athletes

Clinical Trial Details — Status: Recruiting

Administrative data
NCT number NCT00847353
Other study ID # WIN_01
Secondary ID
Status Recruiting
Phase N/A
First received February 18, 2009
Last updated February 3, 2010
Start date February 2009
Est. completion date June 2010

Study information
Verified date February 2010
Source BSP Biological Signal Processing Ltd.
Contact • Irena Imanuel, MD
Phone 09-8639420
Is FDA regulated No
Health authority Israel: Ethics Commission
Study type Observational

Clinical 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. 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.

Recruitment information / eligibility
Status Recruiting
Enrollment 300
Est. completion date June 2010
Est. primary completion date February 2010
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Both
Age group 18 Years to 65 Years
Eligibility 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

Study Design

Time Perspective: Prospective

Related Conditions & MeSH terms

Locations
Country Name City State
Israel The Ribstein Center for Sports Medicine and Research Netanya

Sponsors (1)
Lead Sponsor Collaborator
BSP Biological Signal Processing Ltd.

Country where clinical trial is conducted

Israel, 

Outcome
Type Measure Description Time frame Safety issue
Primary Normal values for depolarization characteristics will be established for study groups end of data collection No
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