Clinical trial NCT05867407: A Multicenter Pragmatic Implementation Study of ECG-AI-Based Clinical Decision Support Software to Identify Low LVEF
Official title: A Prospective Pragmatic Cluster-Randomized Care-as-Usual Controlled Study to Evaluate the Impact of an ECG-Based AI Algorithm to Detect Low Left Ventricular Ejection Fraction on Diagnosis Rates of LVEF ≤40% in the Outpatient Setting
Study type: INTERVENTIONAL
Overall status: ENROLLING_BY_INVITATION
Phase: NA
Conditions: Ventricular Ejection Fraction
Lead sponsor: Anumana, Inc.
Sponsor class: INDUSTRY
Collaborators: name: Mayo Clinic
First posted: 2023-05-22
Enrollment: 50198
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Clinicians in primary care practice groups will be consented for enrollment into the study. Practice groups that decide to participate in the study will be randomized to have the software available or to provide care as usual without the software.
Primary purpose: SCREENING

Brief summary: A prospective, cluster-randomized, care-as-usual controlled trial to evaluate the impact of an ECG-based artificial intelligence (ECG-AI) algorithm to detect low left ventricular ejection fraction (LVEF) on diagnosis rates of LVEF ≤ 40% in the outpatient setting.

The objective of this study is to evaluate the impacts of an ECG-AI algorithm to detect low LVEF and an associated Medical Device Data System when used during routine outpatient care. The study will be conducted in 2 phases: feasibility assessment phase and clinical impact phase.

Detailed description: The study is a prospective, cluster randomized, care-as-usual controlled trial that will be conducted at 6 sites in the USA.

Primary care clinicians and general cardiologists will be invited and consented to participate in the study. For clinicians that accept, practice groups will be randomized to receive access to and education about the Low EF AI-ECG software and encompassing software or to provide care-as-usual in the control group. The study will be conducted in two phases: a feasibility pilot to evaluate integration and usability followed by observational period(s) to evaluate clinical outcomes.

Analyses of the primary and secondary endpoints will be conducted on data from patients that meet the inclusion and exclusion criteria. The expected duration of the study is 12 months, including a feasibility phase (estimated 6 weeks) followed by a 3-month initial observation period with rolling observation count monitoring until the target number of patient encounters is reached, followed by a 90-day follow up period.

At the completion of the feasibility period, we will evaluate quantitative and qualitative outcomes to inform the following observational period(s).

Primary endpoints and exploratory endpoints will be assessed the end of the study.

Eligibility criteria: Inclusion Criteria:

* Males and females 18 years or older (including females who are pregnant, breastfeeding and/or lactating)
* Digital ECG captured or available within site for ECG-AI analysis at point-of-care

Exclusion Criteria:

* Known history of LVEF ≤ 40%
* Known history of systolic heart failure
* Known history of heart failure with reduced ejection fraction
* Opted out of electronic health record-based research

Primary outcomes:
measure: Diagnosis rates of low ejection fraction of less than or equal to 40 percent by echocardiography compared to care-as-usual
timeFrame: 90 days
Secondary outcomes:
Other outcomes:
Locations:
city: Phoenix
country: United States
facility: Mayo Clinic Arizona
state: Arizona
city: Jacksonville
country: United States
facility: Mayo Clinic Florida
state: Florida
city: Rochester
country: United States
facility: Mayo Clinic Rochester
state: Minnesota
city: Durham
country: United States
facility: Duke Health
state: North Carolina
city: Dallas
country: United States
facility: University of Texas Southwestern
state: Texas
Study officials:
affiliation: Mayo Clinic
name: Francisco Lopez-Jimenez, MD, MSc, MBA
role: PRINCIPAL_INVESTIGATOR
References: