Aortic Stenosis
Conditions
Keywords
aortic stenosis, artificial intelligence
Brief summary
The DETECT-AS Diagnostic Study will assess the performance of artificial intelligence (AI) risk predictions to detect aortic stenosis using results from portable electrocardiogram (ECG) and cardiac ultrasound devices.
Interventions
DIAGNOSTIC_TESTPortable 1-lead electrocardiogram
Portable 1-lead electrocardiogram (ECG) performed with the FDA-approved AliveCor KardiaMobile device.
DIAGNOSTIC_TESTPoint-of-care ultrasound
Point-of-care ultrasound performed with the FDA-approved VScan Air device.
OTHERAI-ECG risk algorithm
Artificial intelligence (AI) risk algorithm for aortic stenosis using a 1-lead electrocardiogram
OTHERAI-POCUS
Artificial intelligence (AI) risk algorithm for aortic stenosis using cardiac ultrasound plax videos.
Sponsors
National Institute on Aging (NIA)
Icahn School of Medicine at Mount Sinai
The Methodist Hospital Research Institute
Yale University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
DIAGNOSTIC
Masking
TRIPLE (Subject, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
70 Years to No maximum
Healthy volunteers
Yes
Inclusion criteria
* Age 70 years or older * Attending a routine outpatient primary care clinic at one of the three enrollment sites
Exclusion criteria
* Opted out of research studies * Non-English speaking * Urgent or emergent visits, defined as a visit for an illness or injury that needs attention quickly or is life-threatening * Any echocardiogram within 12 months of clinic visit * Prior history of moderate or severe AS * Prior history of aortic valve replacement or repair, including transcatheter and surgical AVR with either a bioprosthetic or mechanical valve * Presence of implantable cardiac devices, including permanent cardiac pacer, implantable cardioverter-defibrillator, or left ventricular assist device * Prior heart transplant * History of dementia * Documented life expectancy of \<1 year or current participation in hospice services.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of participants diagnosed with advanced aortic stenosis (AS) by transthoracic echocardiogram (TTE) | Until 12 months from the baseline visit | The number of participants diagnosed with advanced AS by TTE at 12 months. Diagnosis of advanced AS is defined as diagnosis of moderate or severe AS as documented in the participant's electronic health record (EHR) at 12 months and adjudication of outcome via review of echocardiographic reports and videos performed by blinded members of the echocardiographic lab at the coordinating center. |
Countries
United States
Outcome results
None listed