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

NCT05210010 · Status: UNKNOWN · Phase: NA · Type: INTERVENTIONAL · Enrollment: 8

Last updated 2022-01-27

No results posted yet for this study

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")

Interventions

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).

Sponsors & Collaborators

  • Ensho Health Intelligent Systems Inc.

    lead INDUSTRY

Principal Investigators

  • Taha Bandukwala, MD · Chief Medical Officer

Study Design

Allocation
NA
Purpose
SCREENING
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
30 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2021-11-01
Primary Completion
2022-05-31
Completion
2022-05-31

Countries

  • Canada

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05210010 on ClinicalTrials.gov