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

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

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

Conditions
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Transthyretin Amyloid Cardiomyopathy (ATTR-CM)

Intervention / Treatment
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* Device: CA-4F


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 30 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Screening
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: Algorithm<br>All participating cardiologists. | Device: CA-4F<br>* 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).<br>|

What is the study measuring?
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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 |