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

NCT ID: NCT01218334

Last Updated: 2017-11-09

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

300 participants

Study Classification

OBSERVATIONAL

Study Start Date

2008-06-30

Study Completion Date

2012-02-29

Brief Summary

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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

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Conditions

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Cardiac Electrical Function

Study Design

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Observational Model Type

CASE_ONLY

Study Time Perspective

PROSPECTIVE

Study Groups

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1

Cardiac Inpatient

No interventions assigned to this group

2

Cardiac Outpatient

No interventions assigned to this group

3

Cardiac Clinic Patient

12 Lead Glove

Intervention Type DEVICE

Comparison of EKG's derived from the 12 Lead Glove vs. the Gold Standard EKG machine

Interventions

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12 Lead Glove

Comparison of EKG's derived from the 12 Lead Glove vs. the Gold Standard EKG machine

Intervention Type DEVICE

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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NYU Langone Health

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Anthony Aizer, MD

Role: PRINCIPAL_INVESTIGATOR

NYU Langone Health

Locations

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New York University Medical Center

New York, New York, United States

Site Status

Countries

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United States

Other Identifiers

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06-777

Identifier Type: -

Identifier Source: org_study_id