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

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ClinicalTrials.gov Identifier: NCT01218334
Recruitment Status : Completed
First Posted : October 11, 2010
Last Update Posted : November 9, 2017
Sponsor:
Information provided by (Responsible Party):
New York University School of Medicine

Brief Summary:

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 or disease Intervention/treatment
Cardiac Electrical Function Device: 12 Lead Glove

Study Type : Observational
Actual Enrollment : 300 participants
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
Study Start Date : June 2008
Primary Completion Date : February 2012
Study Completion Date : February 2012

Group/Cohort Intervention/treatment
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



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


Information from the National Library of Medicine

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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.

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
New York, New York, United States, 10016
Sponsors and Collaborators
New York University School of Medicine
Investigators
Principal Investigator: Anthony Aizer, MD New York University School of Medicine

Responsible Party: New York University School of Medicine
ClinicalTrials.gov Identifier: NCT01218334     History of Changes
Other Study ID Numbers: 06-777
First Posted: October 11, 2010    Key Record Dates
Last Update Posted: November 9, 2017
Last Verified: November 2017

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No