Back to resultsThe Role of High Density Surface ECG in the Diagnosis of Arrhythmogenic Right Ventricular Cardiomyopathy (ARVC)
Primary Purpose
Arrhythmogenic Right Ventricular Cardiomyopathy
Status
Completed
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
80 lead ECG
Sponsored by
About this trial
This is an interventional diagnostic trial for Arrhythmogenic Right Ventricular Cardiomyopathy
Eligibility Criteria
Inclusion Criteria:
- Patients with a confirmed diagnosis of arrhythmogenic right ventricular cardiomyopathy who are being followed up in the cardiology clinic
Exclusion Criteria:
- Inability to consent
- Pacing dependent patients
- Other concomitant cardiag disease e.g. coronary artery disease
- Atrial fibrillation
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm Type
Other
Other
Arm Label
Patient
Healthy volunteers
Arm Description
Patients with previously confirmed Arrhythmogenic Right Ventricular Cardiomyopathy (ARVC)
Aged and gender matched healthy controls.
Outcomes
Primary Outcome Measures
QRS wave dispersion in an ECG
The difference in QRS wave dispersion between the right and left ventricular leads
Secondary Outcome Measures
Full Information
NCT ID
NCT02291393
First Posted
November 11, 2014
Last Updated
May 18, 2015
Sponsor
The Leeds Teaching Hospitals NHS Trust
1. Study Identification
Unique Protocol Identification Number
NCT02291393
Brief Title
The Role of High Density Surface ECG in the Diagnosis of Arrhythmogenic Right Ventricular Cardiomyopathy (ARVC)
Official Title
The Role of High Density Surface Cardiac Electrographic Mapping in the Diagnosis of Arrhythmogenic Right Ventricular Cardiomyopathy :A Pilot Study
Study Type
Interventional
2. Study Status
Record Verification Date
May 2015
Overall Recruitment Status
Completed
Study Start Date
August 2012 (undefined)
Primary Completion Date
October 2012 (Actual)
Study Completion Date
October 2012 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
The Leeds Teaching Hospitals NHS Trust
4. Oversight
5. Study Description
Brief Summary
The diagnosis of Arrhythmogenic right ventricular cardiomyopathy can be difficult. The 80 lead ECG may increase the specificity and sensitivity in diagnosing this potentially life threatening inherited cardiac condition. This pilot would form the basis of a much larger clinical trial to test the utility of this novel diagnostic tool.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Arrhythmogenic Right Ventricular Cardiomyopathy
7. Study Design
Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
20 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Patient
Arm Type
Other
Arm Description
Patients with previously confirmed Arrhythmogenic Right Ventricular Cardiomyopathy (ARVC)
Arm Title
Healthy volunteers
Arm Type
Other
Arm Description
Aged and gender matched healthy controls.
Intervention Type
Device
Intervention Name(s)
80 lead ECG
Primary Outcome Measure Information:
Title
QRS wave dispersion in an ECG
Description
The difference in QRS wave dispersion between the right and left ventricular leads
Time Frame
5 minutes
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
Patients with a confirmed diagnosis of arrhythmogenic right ventricular cardiomyopathy who are being followed up in the cardiology clinic
Exclusion Criteria:
Inability to consent
Pacing dependent patients
Other concomitant cardiag disease e.g. coronary artery disease
Atrial fibrillation
12. IPD Sharing Statement
Learn more about this trial
The Role of High Density Surface ECG in the Diagnosis of Arrhythmogenic Right Ventricular Cardiomyopathy (ARVC)
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