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

Completed

• Conditions: Cardiac Electrical Function
• Interventions: Device: 12 Lead Glove

• Registration Number: NCT01218334
• Lead Sponsor: NYU Langone Health

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2008-06
• Study First Submitted: 2010-10-07
• Study First Submitted QC: 2010-10-08
• Study First Posted: 2010-10-11
• Primary Completion: 2012-02
• Study Completion: 2012-02
• Status Verified: 2017-11
• Last Update Submitted: 2017-11-07
• Last Update Posted: 2017-11-09

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 300

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
3	12 Lead Glove	Cardiac Clinic Patient

Primary Outcome Measures

Name	Time	Method
comparison of Hand ECG to standard ECG with physician over-read	1 year

Trial Locations

Locations (1)

New York University Medical Center; 🇺🇸 New York, New York, United States