NCT00847353

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
300

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Feb 2009

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 1, 2009

Completed
17 days until next milestone

First Submitted

Initial submission to the registry

February 18, 2009

Completed
1 day until next milestone

First Posted

Study publicly available on registry

February 19, 2009

Completed
12 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2010

Completed
4 months until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2010

Completed
Last Updated

February 4, 2010

Status Verified

February 1, 2010

Enrollment Period

1 year

First QC Date

February 18, 2009

Last Update Submit

February 3, 2010

Conditions

Keywords

high frequency ECGnormal valuesasymptomaticobese

Outcome Measures

Primary Outcomes (1)

  • Normal values for depolarization characteristics will be established for study groups

    end of data collection

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

community sample referred or self referred to stress testing

You may qualify if:

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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

The Ribstein Center for Sports Medicine and Research

Netanya, Israel

RECRUITING

MeSH Terms

Conditions

Obesity

Condition Hierarchy (Ancestors)

OverweightOvernutritionNutrition DisordersNutritional and Metabolic DiseasesBody WeightSigns and SymptomsPathological Conditions, Signs and Symptoms

Central Study Contacts

• Irena Imanuel, MD

CONTACT

Eyal Shargal, PhD

CONTACT

Study Design

Study Type
observational
Time Perspective
PROSPECTIVE
Sponsor Type
INDUSTRY

Study Record Dates

First Submitted

February 18, 2009

First Posted

February 19, 2009

Study Start

February 1, 2009

Primary Completion

February 1, 2010

Study Completion

June 1, 2010

Last Updated

February 4, 2010

Record last verified: 2010-02

Locations