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

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.

Study Overview

• Status: Enrolling by invitation
• Conditions: Transthyretin Amyloid Cardiomyopathy ("ATTR-CM")
• Intervention / Treatment: Device: CA-4F

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 patients suitable for follow-up investigations.

The algorithm will be used to screen electronic health records of participating cardiologists for patients suitable for PYP scans to investigate potential ATTR-CM and determine its positive predictive value.

Input parameters to the algorithm will be extracted from the pseudonymized electronic health records of patients who visited participating cardiologists in the 12 months preceding their enrolment.

The records of patients with elevated pre-test likelihood of ATTR-CM will be queried for Canadian Heart Failure Society red flag symptoms to facilitate clinical review. Participating cardiologists will review the red flag symptoms and electronic health records of patients with elevated pre-test likelihoods and document whether further investigation with PYP is clinically justified with supporting rationale.

Patients for which further investigation is clinically justified will be referred for confirmatory testing and the results of additional investigations will be documented. The positive predictive values of "moderate", "high" and "very high" CA-4F Risk Scores will be calculated by determining the percentage of those patients for which further investigations were performed and resulted in diagnosis of ATTR-CM.

• Study Type: Interventional
• Enrollment (Anticipated): 8
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Canada
  • British Columbia
    • North Vancouver, British Columbia, Canada
      • Site 85237
  • Ontario
    • Oakville, Ontario, Canada
      • Site 26174
    • Scarborough, Ontario, Canada
      • Site 47844

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 30 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• 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 Criteria:

• 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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Screening
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

Other: Algorithm; All participating cardiologists.

Device: CA-4F; 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).

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Clinical utility of CA-4F	Positive predictive value of "moderate" or greater CA-4F Risk Score as confirmed by PYP scan	Six months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Optimal threshold for clinical use	Positive predictive values of "moderate," "high," "very high," and "high" or greater CA-4F Risk Scores as confirmed by PYP scan	Six months

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Impacts of CA-4F on age at first diagnosis	Difference in age at diagnosis of patients diagnosed through the study and patients of participating cardiologists previously diagnosed with ATTR-CM	Six months
Impacts of CA-4F on rate of diagnosis in priority subgroups	Difference in biological sex distribution and left ventricular wall thickness measurements of patients diagnosed through the study and patients of participating cardiologists previously diagnosed with ATTR-CM	Six months

Collaborators and Investigators

• Sponsor: Ensho Health Intelligent Systems Inc.
• Investigators: Principal Investigator: Taha Bandukwala, MD, Chief Medical Officer

Study record dates

Study Major Dates

• Study Start (Actual): November 1, 2021
• Primary Completion (Anticipated): May 31, 2022
• Study Completion (Anticipated): May 31, 2022

Study Registration Dates

• First Submitted: December 30, 2021
• First Submitted That Met QC Criteria: January 13, 2022
• First Posted (Actual): January 27, 2022

Study Record Updates

• Last Update Posted (Actual): January 27, 2022
• Last Update Submitted That Met QC Criteria: January 13, 2022
• Last Verified: January 1, 2022

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Heart Diseases; Cardiovascular Diseases; Cardiomyopathies
• Other Study ID Numbers: SA001401001

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No