Transthyretin Amyloid Cardiomyopathy ("ATTR-CM")NCT05210010
A Prospective Study to Assess the Utility of CA-4F in a Canadian Cardiology Setting
A study testing CA-4F in people with Transthyretin Amyloid Cardiomyopathy ("ATTR-CM"), run by Ensho Health Intelligent Systems Inc. at 3 sites in Canada.
Trial 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. Read more about this study
- Who is it for?
- Ages 30 years and older
- Conditions the study is for
- Transthyretin Amyloid Cardiomyopathy ("ATTR-CM")
- What is being tested?
- CA-4F
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 8 participants
- Where
- 3 sitesCanada
- Study dates
- 1 Nov 2021to 31 May 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 30 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
3 sites in 1 country.
Canada3 sites
Site 85237
North Vancouver, British Columbia
Site 26174
Oakville, Ontario
Site 47844
Scarborough Village, Ontario
About this study
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.
Read the 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.
- Being tested
- CA-4F
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CA-4FDevice
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).
| Study group | Role | What they receive |
|---|---|---|
| Algorithm | Other | All participating cardiologists. Receives: Device: CA-4F |
What is being measured
The primary outcome is the main question the study is designed to answer.
Clinical utility of CA-4F
Positive predictive value of "moderate" or greater CA-4F Risk Score as confirmed by PYP scan
Measured: Six months
Secondary outcomes (1)
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
Measured: Six months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Jan 2022
- Study start1 Nov 2021
- Primary completion31 May 2022 (estimated)
- Study completion31 May 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Transthyretin Amyloid Cardiomyopathy ("ATTR-CM")Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Screening
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 8 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Ensho Health Intelligent Systems Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Taha Bandukwala, MD, Principal investigator, Chief Medical Officer
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05210010
- Sponsor's protocol ID
- SA001401001
- Status last verified
- Jan 2022
- First submitted
- 30 Dec 2021
- Last updated
- 27 Jan 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Jan 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective Study to Assess the Utility of CA-4F in a Canadian Cardiology Setting
- ClinicalTrials.gov ID
- NCT05210010
- Acronym / sponsor ID
- SA001401001
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 8 participants (estimated)
- Lead sponsor
- Ensho Health Intelligent Systems Inc.Industry (pharma, biotech, devices)
- Study start
- 1 Nov 2021 (actual)
- Primary completion
- 31 May 2022 (estimated)
- Study completion
- 31 May 2022 (estimated)
- First posted
- 27 Jan 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
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 design
- Primary purpose
- Screening
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Algorithm | Other | Device: CA-4FAll participating cardiologists. |
Who may qualify
- Ages
- 30 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 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
Key exclusion criteria (6 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| CA-4FThe 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). | Device | Algorithm |
Primary outcome
Clinical utility of CA-4F
Time frame: Six months
Positive predictive value of "moderate" or greater CA-4F Risk Score as confirmed by PYP scan
1 secondary outcome
Optimal threshold for clinical use
Time frame: Six months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Jan 2022.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Taha Bandukwala, MD principal investigator
Chief Medical Officer
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing CA-4F in people with Transthyretin Amyloid Cardiomyopathy ("ATTR-CM"), run by Ensho Health Intelligent Systems Inc. at 3 sites in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 27 Jan 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Clinical utility of CA-4F (time frame: Six months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Jan 2022.