A Randomized, Single Blind, Comparative Trial of Standardized 12 Lead ECG to the 12 Lead ECG Glove for the Assessmant of Cardiac Electrical Function
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Cardiac Electrical Function
- Sponsor
- NYU Langone Health
- Enrollment
- 300
- Locations
- 1
- Primary Endpoint
- comparison of Hand ECG to standard ECG with physician over-read
- Status
- Completed
- Last Updated
- 8 years ago
Overview
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.
Investigators
Eligibility Criteria
Inclusion Criteria
- •Preop assessment for elective cardiac catheterization or EP procedure.
- •Outpatient cardiology appointments.
- •Inpatients admitted with a cardiac diagnosis
Exclusion Criteria
- •Age less than
- •Skin breakdown.
Outcomes
Primary Outcomes
comparison of Hand ECG to standard ECG with physician over-read
Time Frame: 1 year