Deep Learning Enhanced Detection of Aortic Stenosis - The DETECT-AS-Diagnostic Study

Not Applicable

Not yet recruiting

• Conditions: Aortic Stenosis

• Registration Number: NCT06749145
• Lead Sponsor: Yale University

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.

Detailed Description

Not available

Study Timeline

• Status Verified: 2024-12
• Study First Submitted: 2024-12-19
• Study First Submitted QC: 2024-12-19
• Last Update Submitted: 2024-12-19
• Study First Posted: 2024-12-27
• Last Update Posted: 2024-12-27
• Study Start: 2025-03-01
• Primary Completion: 2028-08-31
• Study Completion: 2028-08-31

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 410

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
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.

Trial Locations

Locations (3)

Santa Clara Medical Center - Kaiser Permanente; 🇺🇸 Santa Clara, California, United States

Yale New Haven Health System; 🇺🇸 New Haven, Connecticut, United States

Icahn School of Medicine at Mount Sinai; 🇺🇸 New York, New York, United States