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:
Collaborator:
ineedMD
Information provided by (Responsible Party):
New York University School of Medicine
ClinicalTrials.gov Identifier:
NCT01218334
First received: October 7, 2010
Last updated: April 5, 2013
Last verified: April 2013
  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 ] [ Designated as safety issue: No ]

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

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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
Please refer to this study by its ClinicalTrials.gov identifier: 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

No publications provided

Responsible Party: New York University School of Medicine
ClinicalTrials.gov Identifier: NCT01218334     History of Changes
Other Study ID Numbers: ineedMD 06-777
Study First Received: October 7, 2010
Last Updated: April 5, 2013
Health Authority: United States: Food and Drug Administration

ClinicalTrials.gov processed this record on April 15, 2014