Hypertrophic Cardiomyopathy
Conditions
Keywords
Artificial Intelligence, HCM
Brief summary
To describe the clinical, economic, and population characteristics of newly diagnosed, previously diagnosed, and suspected patients evaluated by Viz HCM. HCM is underdiagnosed in the community and AI algorithms have been developed as screening tools. However, it is not well understood how to best integrate AI screening tools and their potential impact.
Interventions
DEVICEViz HCM
Viz HCM is a Software as a Medical Device (SaMD) intended to receive 12-lead ECG recordings collected as part of a routine clinical assessment and analyze them in parallel to the standard of care. The device uses a machine learning based algorithm to analyze 12-lead ECGs and identify ECGs with suspected HCM.
Sponsors
Viz.ai, Inc.
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
All Cohorts * Patients aged 18+ years at time of arrival to healthcare facility * Patients with a resting 12-lead digital electrocardiogram (ECG) that is flagged by Viz HCM for HCM suspicion Additional cohort-specific criteria: Cohort 1 - Newly Diagnosed Patients * Patients have been diagnosed with HCM after the Viz HCM implementation * Written informed consent is obtained prior to data collection Cohort 2 - Previously Diagnosed Patients ● Prior diagnosis of HCM as evidenced by clinical diagnosis documentation prior to Viz HCM implementation Cohort 3 - Suspected and Not Diagnosed Patients ● Patients did not receive sufficient clinical workup for HCM diagnosis confirmation Cohort 4 - Unlikely HCM ● Patient ECG moved to 'Unlikely HCM' group within Viz by site study staff following HCM alert review Cohort 5 - Alerts Not Reviewed ● HCM alert not reviewed by site study staff during study enrollment period
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Health economics outcome as captured by ICD placement data | Up to 3 years | To describe healthcare utilization and economic outcomes as captured by ICD placement for primary and secondary prevention for sudden cardiac death. |
| Healthcare utilization and health economic outcomes- medical clinic visits | Up to 3 years | To describe healthcare utilization and economic outcomes as captured by medical clinic visits, associated testing (e.g., echocardiogram, cardiac MRI, laboratory and genetic screening), hospitalization, and ICD placement for primary and secondary prevention for sudden cardiac death. |
| Health economics outcome as captured by associated testing modalities | Up to 3 years | To describe healthcare utilization and economic outcomes as captured by associated testing |
| Health economics outcome as captured by hospitalization data | Up to 3 years | To describe healthcare utilization and economic outcomes as captured by hospitalization data |
| Clinical characteristics of Viz HCM AI screening on HCM diagnosis | Up to 3 years | To describe the clinical characteristics of patients who were alerted for suspected HCM by an AI-based ECG tool and newly diagnosed, previously diagnosed, or suspected for HCM. |
| Clinical characteristics of Viz HCM AI screening on medical workup. | Up to 3 years | To describe the clinical characteristics of medical workup for patients who were alerted for suspected HCM by an AI-based ECG tool and newly diagnosed, previously diagnosed, or suspected for HCM. |
| Clinical characteristics of Viz HCM AI screening on treatment plans. | Up to 3 years | To describe the clinical characteristics of treatment plans for patients who were alerted for suspected HCM by an AI-based ECG tool and newly diagnosed, previously diagnosed, or suspected for HCM. |
| Clinical characteristics of Viz HCM AI screening on closed care pathways | Up to 3 years | To describe the clinical characteristics of closed care pathways (patients diagnosed who receive treatment) for patients who were alerted for suspected HCM by an AI-based ECG tool and newly diagnosed, previously diagnosed, or suspected for HCM. |
| Population evaluation for access to care by socioeconomic status at the time of diagnosis. | Up to 3 years | To describe HCM access to care by socioeconomic status at the time of diagnosis. |
| Population evaluation for access to care by clinical stage of HCM at time of diagnosis. | Up to 3 years | Population evaluation for access to care by clinical stage of HCM at time of diagnosis. |
Secondary
| Measure | Time frame |
|---|---|
| Implementation science - number of active users over time | Up to 2 years |
| Implementation science - reasons for user-indicated actions, where documented | Up to 2 years |
| Implementation science - percentage of alerts viewed | Up to 2 years |
Countries
United States
Contacts
Primary ContactSloane Smith-Saunders, MBA, MPH
Backup ContactEthan Carter, BSN
Outcome results
None listed