Addressing Under-treatment and Health Equity in AS and MR Using an Integrated EHR Platform

Launched by TEMPUS AI · Oct 19, 2023

Keywords

ClinConnect Summary

This clinical trial is studying how automated alerts can help doctors identify and treat patients with severe aortic stenosis (narrowing of the heart's aortic valve) and severe mitral regurgitation (leakage of the heart's mitral valve). The goal is to see if these alerts lead to more patients receiving the necessary procedures or evaluations from a specialized heart care team. The trial will compare two groups: one that receives these alerts and another that does not, to see which group has better follow-up care and treatment for their heart conditions.

To be eligible for this study, participants should be adults aged 65 and older with specific findings related to their heart valves based on an echocardiogram (a special ultrasound of the heart). For instance, they might have severe narrowing of the aortic valve or significant leakage of the mitral valve. Participants will be recruited from multiple centers, and they can expect to have their care closely monitored throughout the study. This research aims to improve treatment access and health equity, considering factors like race, ethnicity, and geography. If you or someone you know might be interested in participating, it’s a good idea to discuss this with a healthcare provider.

Gender

ALL

Eligibility criteria

• At least one of the following three options for aortic stenosis and/or the single option for mitral regurgitation are determined from echocardiogram findings:
• • 1. AVA or DI (Patients with either Aortic valve area (AVA) or Dimensionless Index (DI) measured in their echo as well as at least one hemodynamic measure above the minimum threshold)
• • a. Either: i. Aortic Valve Area ≤ 1.0 cm2 ii. Dimensionless Index ≤ 0.25 b. AND ANY of i. Aortic Mean Gradient ≥ 15 mmHg ii. Aortic Peak Gradient ≥ 30 mmHg iii. Aortic Jet Velocity ≥ 2.75 m/s
• • 2. AVA + OTHER (Patients with AVA and at least 1 other echo measurement in their echo above the threshold)
• • 1. 1.0 cm2 \< Aortic Valve Area ≤ 1.2 cm2
• 2. AND ANY of:
• • i. Aortic Mean Gradient ≥ 40 mmHg ii. Aortic Peak Gradient ≥ 64 mmHg iii. Aortic Jet Velocity ≥ 4.0 m/s
• • 3. POSSIBLE (Possible Aortic Stenosis but requires human review) a. Aortic Valve Area is NULL OR \>1.2 cm2 b. AND ANY of: i. Aortic Mean Gradient ≥ 40 mmHg ii. Aortic Peak Gradient ≥ 64 mmHg iii. Aortic Jet Velocity ≥ 4.0 m/s OR a. EITHER i. Aortic Valve Area ≤ 1.0 cm2 ii. Dimensionless Index ≤ 0.25 b. AND ALL are: i. Aortic Mean Gradient \< 15 mmHg ii. Aortic Peak Gradient \< 30 mmHg iii. Aortic Peak Velocity \< 2.75 m/s
• • ALERT Study Clinical Investigation Plan Version 2.1 page 12 of 54
• • Any patient flagged for "POSSIBLE" does not result in automatically alerting the provider, instead a notification is sent to the Tempus research team for manual review in conjunction with the site Principal Investigator (PI) and if requested by Tempus or site PI, a Steering Committee member. If clinical confirmation is received for severe aortic stenosis from the site PI, an alert is sent to the provider. 1. Mitral Regurgitation
• • a. Mention of severe mitral regurgitation or moderate- severe mitral regurgitation
• • Any patient mentioned with only moderate MR or a lesser severity will be excluded.
• Exclusion Criteria:
• • 1. Age \< 18 years
• • 2. Patient had evidence of a prior transcatheter or surgical repair or replacement of the target valve
• • 3. The echocardiogram was ordered by a cardiologist on the MHT or a cardiac surgeon
• • 4. Patient already has a scheduled clinic visit with a member of the MHT or a recent (since the start of the study at that site ) clinic visit with the MHT, or a scheduled transcatheter or surgical VI in the future.