Status:

UNKNOWN

A Prospective Study to Assess the Utility of CA-4F in a Canadian Cardiology Setting

Lead Sponsor:

Ensho Health Intelligent Systems Inc.

Conditions:

Transthyretin Amyloid Cardiomyopathy ("ATTR-CM")

Eligibility:

All Genders

30+ years

Phase:

NA

Brief Summary

This study will assess whether CA-4F can improve diagnosis of ATTR-CM in a community cardiology setting when used to screen electronic medical record data for patients suitable for follow-up investiga...

Detailed Description

This is a prospective multicentre observational study to assess whether CA-4F can improve diagnosis of ATTR-CM in a community cardiology setting when used to screen electronic medical record data for ...

Eligibility Criteria

Inclusion

  • Licensed cardiologist in the Canadian provinces of Ontario, Saskatchewan or British Columbia
  • Outpatient cardiology practice with ≥1,200 unique patients annually
  • Have used an electronic medical record system for ≥36 months from enrollment
  • Currently subscribed to the Advanced Computing Platform by Ensho Health or using a cloud-hosted electronic medical record system compatible with the Apollo Electronic Data Capture System
  • Experience with the clinical management of ATTR-CM
  • Access to PYP scanning for follow-up investigations
  • Previous participation in clinical studies

Exclusion

  • Predominantly hospital-based cardiology practice
  • Have used an electronic medical record system for \<36 months from enrollment
  • Electronic medical record system incompatible with the Apollo Electronic Data Capture system
  • No prior experience with the clinical management of ATTR-CM
  • No access to PYP scanning for follow-on investigations
  • No prior participation in clinical studies

Key Trial Info

Start Date :

November 1 2021

Trial Type :

INTERVENTIONAL

Allocation :

ESTIMATED

End Date :

May 31 2022

Estimated Enrollment :

8 Patients enrolled

Trial Details

Trial ID

NCT05210010

Start Date

November 1 2021

End Date

May 31 2022

Last Update

January 27 2022

Active Locations (3)

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Page 1 of 1 (3 locations)

1

Site 85237

North Vancouver, British Columbia, Canada

2

Site 26174

Oakville, Ontario, Canada

3

Site 47844

Scarborough Village, Ontario, Canada