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

A Randomized, Single Blind, Comparative Trial of Standardized 12 Lead ECG to the 12 Lead ECG Glove for the Assessmant of Cardiac Electrical Function

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.

Study Overview

• Status: Completed
• Conditions: Cardiac Electrical Function
• Intervention / Treatment: Device: 12 Lead Glove

• Study Type: Observational
• Enrollment (Actual): 300

Contacts and Locations

Study Locations

• United States
  • New York
    • New York, New York, United States, 10016
      • New York University Medical Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 14 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

Cardiology Patients

Description

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.

Study Plan

How is the study designed?

Design Details

• Observational Models: Case-Only
• Time Perspectives: Prospective

Number of groups / cohorts

3

Cohorts and Interventions

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
comparison of Hand ECG to standard ECG with physician over-read	1 year

Collaborators and Investigators

• Sponsor: NYU Langone Health
• Investigators: Principal Investigator: Anthony Aizer, MD, NYU Langone Health

Study record dates

Study Major Dates

• Study Start: June 1, 2008
• Primary Completion (Actual): February 1, 2012
• Study Completion (Actual): February 1, 2012

Study Registration Dates

• First Submitted: October 7, 2010
• First Submitted That Met QC Criteria: October 8, 2010
• First Posted (Estimate): October 11, 2010

Study Record Updates

• Last Update Posted (Actual): November 9, 2017
• Last Update Submitted That Met QC Criteria: November 7, 2017
• Last Verified: November 1, 2017

More Information

Terms related to this study

• Other Study ID Numbers: 06-777

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No