Deep Learning-enhanced Personalized Monitoring of Aortic Stenosis - The DETECT-AS Prognostic Study

NCT ID: NCT06749132

Last Updated: 2026-02-06

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

NOT_YET_RECRUITING

Total Enrollment

210 participants

Study Classification

OBSERVATIONAL

Study Start Date

2026-04-01

Study Completion Date

2028-08-31

Brief Summary

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This study will evaluate the validity of a digital biomarker score for precision risk stratification among older adults with aortic sclerosis or mild aortic stenosis (AS) at three US health systems.

Detailed Description

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Conditions

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Aortic Stenosis

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Interventions

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Transthoracic echocardiogram

All study participants will undergo a clinical transthoracic echocardiogram (TTE) performed by certified echocardiography technicians. The TTE includes standard transthoracic examination with acquisition of B-mode, color and spectral Doppler images and videos in line with standard echocardiographic guidelines.

Intervention Type DIAGNOSTIC_TEST

Eligibility Criteria

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Inclusion Criteria

1. Age 65 years or older
2. Prior transthoracic echocardiogram within the past 2-3 years showing aortic sclerosis without stenosis or mild AS

Exclusion Criteria

1. Opted out of research studies
2. Non-English speaking
3. Any echocardiogram within 24 months of medical record review.
4. Prior history of aortic valve replacement or repair, including transcatheter and surgical AVR with either a bioprosthetic or mechanical valve
5. Presence of implantable cardiac devices, including permanent cardiac pacer, implantable cardioverter-defibrillator, or left ventricular assist device
6. Prior heart transplant
7. History of dementia
8. Unable to attend study visit at echocardiogram lab within four years of most recent echocardiogram.
9. Documented life expectancy of \<1 year or current participation in hospice services
Minimum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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National Institute on Aging (NIA)

NIH

Sponsor Role collaborator

Icahn School of Medicine at Mount Sinai

OTHER

Sponsor Role collaborator

The Methodist Hospital Research Institute

OTHER

Sponsor Role collaborator

Yale University

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Rohan Khera, MD, MS

Role: PRINCIPAL_INVESTIGATOR

Yale University

Locations

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Yale New Haven Health System

New Haven, Connecticut, United States

Site Status

Icahn School of Medicine at Mount Sinai

New York, New York, United States

Site Status

The Methodist Hospital Research Institute

Houston, Texas, United States

Site Status

Countries

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United States

Central Contacts

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Rohan Khera, MD, MS

Role: CONTACT

203-764-5885

Facility Contacts

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Rohan Khera, MD, MS

Role: primary

203-764-5885

Ira Hofer, MD

Role: primary

646-901-9237

Sadeer Al-Kindi, MD

Role: primary

713-441-2848

Other Identifiers

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R01AG089981

Identifier Type: NIH

Identifier Source: secondary_id

View Link

2000038730

Identifier Type: -

Identifier Source: org_study_id

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