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

NCT05210010 | Unknown

• 1 other identifier: SA001401001
• Study Type: interventional
• Target: 8
• Locations: 1 country
• Sites: 3

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 investigations.

Conditions

Transthyretin Amyloid Cardiomyopathy ("ATTR-CM")

Outcome Measures

Primary Outcomes (1)

• Clinical utility of CA-4F

  Positive predictive value of "moderate" or greater CA-4F Risk Score as confirmed by PYP scan

  Six months

Secondary Outcomes (1)

• Optimal threshold for clinical use

  Six months

Other Outcomes (2)

• Impacts of CA-4F on age at first diagnosis

  Six months

• Impacts of CA-4F on rate of diagnosis in priority subgroups

  Six months

Study Arms (1)

Algorithm

OTHER

All participating cardiologists.

Device: CA-4F

Interventions

CA-4F DEVICE

The study intervention is the CA-4F algorithm developed by Ensho Health. The algorithm is a process for converting input parameters to a CA-4F Risk Score intended to facilitate clinical prioritization of patients suitable for follow-up investigation for ATTR-CM. The algorithm is applied using the CA-4F Likelihood Estimator which encodes it in software and records its outputs. The CA-4F Likelihood Estimator is controlled through a graphical user interface called the CA-4F Controller. The CA-4F Likelihood Estimator and its Controller are Class I medical devices in Canada registered under the Medical Device Establishment License of Ensho Health (license 16208).

Algorithm

Eligibility Criteria

• Age: 30 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Ensho Health Intelligent Systems Inc.: lead

Study Sites (3)

Site 85237

North Vancouver, British Columbia, Canada

Location

Site 26174

Oakville, Ontario, Canada

Location

Site 47844

Scarborough Village, Ontario, Canada

Location

Study Officials

• Taha Bandukwala, MD

  Chief Medical Officer

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: SCREENING
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 30, 2021
• First Posted: January 27, 2022
• Study Start: November 1, 2021
• Primary Completion: May 31, 2022
• Study Completion: May 31, 2022
• Last Updated: January 27, 2022

Record last verified: 2022-01

Locations

CA (3)