We updated the design of this site on September 25th. Learn more.
Show more
ClinicalTrials.gov
ClinicalTrials.gov Menu

A Comparative Trial of Standard 12 Lead ECG to the 12 Lead ECG Glove to Assess Cardiac Electrical Function (HandEKG)

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01218334
First Posted: October 11, 2010
Last Update Posted: April 8, 2013
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborator:
ineedMD
Information provided by (Responsible Party):
New York University School of Medicine
  Purpose

The proposed study is a two-arm, randomized, single-blinded, cross-over Phase III clinical trial in which patients in 3 distinct clinical scenarios will receive the 12LEG, followed by the standard ECG, or vice-versa. Each participant will then apply the Hand ECG themselves. The 3 clinical scenarios will be: 1. patients at preoperative assessment for elective cardiac catheterization or electrophysiology procedures; 2. patients coming for outpatient cardiology appointments; 3. Inpatients admitted with a cardiac diagnosis.

The electrophysiologists reviewing ECGs will be blinded to the equipment utilized to obtain the ECG.


Condition Intervention
Cardiac Electrical Function Device: 12 Lead Glove

Study Type: Observational
Study Design: Observational Model: Case-Only
Time Perspective: Prospective
Official Title: A Randomized, Single Blind, Comparative Trial of Standardized 12 Lead ECG to the 12 Lead ECG Glove for the Assessmant of Cardiac Electrical Function

Further study details as provided by New York University School of Medicine:

Primary Outcome Measures:
  • comparison of Hand ECG to standard ECG with physician over-read [ Time Frame: 1 year ]

Enrollment: 300
Study Start Date: June 2008
Study Completion Date: February 2012
Primary Completion Date: February 2012 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
1
Cardiac Inpatient
2
Cardiac Outpatient
3
Cardiac Clinic Patient
Device: 12 Lead Glove
Comparison of EKG's derived from the 12 Lead Glove vs. the Gold Standard EKG machine

  Eligibility

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population
Cardiology Patients
Criteria

Inclusion Criteria:

  1. Preop assessment for elective cardiac catheterization or EP procedure.
  2. Outpatient cardiology appointments.
  3. Inpatients admitted with a cardiac diagnosis

Exclusion Criteria:

  1. Age less than 18.
  2. Skin breakdown.
  Contacts and Locations
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): NCT01218334


Locations
United States, New York
New York University Medical Center
NYC, New York, United States, 10016
Sponsors and Collaborators
New York University School of Medicine
ineedMD
  More Information

Responsible Party: New York University School of Medicine
ClinicalTrials.gov Identifier: NCT01218334     History of Changes
Other Study ID Numbers: ineedMD 06-777
First Submitted: October 7, 2010
First Posted: October 11, 2010
Last Update Posted: April 8, 2013
Last Verified: April 2013