New York University Medical Center
New York, 10016, United States
Completed
NCT Number: NCT01218334
A Comparative Trial of Standard 12 Lead ECG to the 12 Lead ECG Glove to Assess 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.
Completed
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Notify MeKey information
Conditions
Age range
18 year and older
Sex eligibility
All sexes
Study type
Observational
Primary location
Who can participate
Healthy volunteers accepted: Yes
Only the study team can determine whether someone qualifies for participation.
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.
Treatment and study plan
12 Lead Glove
DeviceComparison of EKG's derived from the 12 Lead Glove vs. the Gold Standard EKG machine
Primary outcomes
-
comparison of Hand ECG to standard ECG with physician over-read
Time frame: 1 year
Sponsors and collaborators
Lead sponsor
NYU Langone Health
Other
Registry information
Official study 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
Acronym: HandEKG
Important dates
- Study start
- 2008
- Primary completion
- 2012
- Study completion
- 2012
- First posted
- Oct 11, 2010
- Registry last updated
- Nov 9, 2017
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.