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| ID | Type | Description | Link |
|---|---|---|---|
| R01AG089981 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| National Institute on Aging (NIA) | NIH |
| Icahn School of Medicine at Mount Sinai | OTHER |
| The Methodist Hospital Research Institute | OTHER |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Intervention | Experimental | The intervention arm will undergo sequential screening for aortic stenosis using portable 1-lead electrocardiograms (ECGs), followed by point-of-care ultrasound (POCUS), if indicated, by artificial intelligence (AI)-based risk algorithms. |
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| Control | Sham Comparator | The control arm will undergo a portable 1-lead electrocardiogram (ECG), with 10% randomly assigned to undergo point-of-care ultrasound (POCUS). |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Portable 1-lead electrocardiogram | Diagnostic Test | Portable 1-lead electrocardiogram (ECG) performed with the FDA-approved AliveCor KardiaMobile device. |
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| Measure | Description | Time Frame |
|---|---|---|
| Number of participants diagnosed with advanced aortic stenosis (AS) by transthoracic echocardiogram (TTE) | 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. | Until 12 months from the baseline visit |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Rohan Khera, MD, MS | Yale University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Yale New Haven Health System | New Haven | Connecticut | 06519 | United States | ||
| Icahn School of Medicine at Mount Sinai |
A de-identified dataset will be made available following publication of primary results.
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| ID | Term |
|---|---|
| D001024 | Aortic Valve Stenosis |
| ID | Term |
|---|---|
| D000082862 | Aortic Valve Disease |
| D006349 | Heart Valve Diseases |
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
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| Point-of-care ultrasound | Diagnostic Test | Point-of-care ultrasound performed with the FDA-approved VScan Air device. |
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| AI-ECG risk algorithm | Other | Artificial intelligence (AI) risk algorithm for aortic stenosis using a 1-lead electrocardiogram |
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| AI-POCUS | Other | Artificial intelligence (AI) risk algorithm for aortic stenosis using cardiac ultrasound plax videos. |
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| New York |
| New York |
| 10029 |
| United States |
| The Methodist Hospital Research Institute | Houston | Texas | 77030 | United States |
| D014694 |
| Ventricular Outflow Obstruction |