A Comparative Trial of Standard 12 Lead ECG to the 12 Lead ECG Glove to Assess Cardiac Electrical Function
Completed
- Conditions
- Cardiac Electrical Function
- 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
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 300
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 18.
- Skin breakdown.
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method comparison of Hand ECG to standard ECG with physician over-read 1 year
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (1)
New York University Medical Center
🇺🇸New York, New York, United States
New York University Medical Center🇺🇸New York, New York, United States