NCT02291393

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.

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
20

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Aug 2012

Shorter than P25 for not_applicable

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

August 1, 2012

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2012

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2012

Completed
2.1 years until next milestone

First Submitted

Initial submission to the registry

November 11, 2014

Completed
3 days until next milestone

First Posted

Study publicly available on registry

November 14, 2014

Completed
Last Updated

May 19, 2015

Status Verified

May 1, 2015

Enrollment Period

2 months

First QC Date

November 11, 2014

Last Update Submit

May 18, 2015

Conditions

Arrhythmogenic Right Ventricular Cardiomyopathy

Outcome Measures

Primary Outcomes (1)

  • QRS wave dispersion in an ECG

    The difference in QRS wave dispersion between the right and left ventricular leads

    5 minutes

Study Arms (2)

Patient

OTHER

Patients with previously confirmed Arrhythmogenic Right Ventricular Cardiomyopathy (ARVC)

Device: 80 lead ECG

Healthy volunteers

OTHER

Aged and gender matched healthy controls.

Device: 80 lead ECG

Interventions

80 lead ECGDEVICE
Healthy volunteersPatient

Eligibility Criteria

Age18 Years - 80 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Patients with a confirmed diagnosis of arrhythmogenic right ventricular cardiomyopathy who are being followed up in the cardiology clinic

You may not qualify if:

  • Inability to consent
  • Pacing dependent patients
  • Other concomitant cardiag disease e.g. coronary artery disease
  • Atrial fibrillation

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Arrhythmogenic Right Ventricular Dysplasia

Condition Hierarchy (Ancestors)

Heart Defects, CongenitalCardiovascular AbnormalitiesCardiovascular DiseasesCardiomyopathiesHeart DiseasesCongenital AbnormalitiesCongenital, Hereditary, and Neonatal Diseases and Abnormalities

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
DIAGNOSTIC
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 11, 2014

First Posted

November 14, 2014

Study Start

August 1, 2012

Primary Completion

October 1, 2012

Study Completion

October 1, 2012

Last Updated

May 19, 2015

Record last verified: 2015-05