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AI-Assisted Heart Monitoring for Heart Disease (ECG-AID Trial)
N/A
Waitlist Available
Led By John Pfeifer, MD
Research Sponsored by Tempus AI
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 18 months
Awards & highlights
No Placebo-Only Group
Summary
This trial is testing two devices that predict who has or may develop atrial fibrillation or structural heart disease, based on an electrocardiogram.
Who is the study for?
This trial is for adults aged 40 or older who have had an ECG during routine care. For the atrial fibrillation group, participants must be 65 or older and able to identify a healthcare provider to receive patch monitor results. For structural heart disease, they need to be at least 40 and can't have severe valve issues or poor heart pump function.
What is being tested?
The study tests two devices: an echocardiogram and Zio Patch Monitor, which may help predict atrial fibrillation or structural heart disease using electrocardiogram results. It includes looking back at past patient data as well as monitoring new patients.
What are the potential side effects?
Potential side effects include skin irritation from the adhesive used in the Zio Patch Monitor and allergic reactions to ultrasound gel used during echocardiograms.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 18 months
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~18 months
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
Positive-predictive value (PPV) of the AF device at six months
Positive-predictive value (PPV) of the SHD device at six months
Secondary study objectives
Positive-predictive value (PPV) of the AF device at 12 months
Positive-predictive value (PPV) of the SHD device at 12 months
Awards & Highlights
No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.
Trial Design
2Treatment groups
Experimental Treatment
Group I: SHD CohortExperimental Treatment1 Intervention
Will be comprised 500 participants at increased risk for Structural Heart Disease (SHD) will be referred for a single echocardiogram.
Group II: AF CohortExperimental Treatment1 Intervention
Will be comprised of 500 participants predicted to be increased risk for Atrial Fibrillation (AF) will receive a 2-week ECG patch monitor to wear (up to 3 times over 12 months),
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Echocardiogram
2016
Completed Phase 2
~1910
Find a Location
Who is running the clinical trial?
Tempus AILead Sponsor
16 Previous Clinical Trials
18,472 Total Patients Enrolled
Tempus LabsLead Sponsor
16 Previous Clinical Trials
18,972 Total Patients Enrolled
John Pfeifer, MDPrincipal InvestigatorTempus AI, Inc.
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Eligibility Criteria:
This trial includes the following eligibility criteria:- I am over 40 and had an ECG for care between the study dates. I can name a healthcare provider for my echocardiogram results.You cannot finish the follow-up studies on time, are currently in the hospital, have a permanent pacemaker or implanted cardiac defibrillator, have a history of certain heart conditions, had recent or planned heart surgery, or are allergic to adhesive.I can follow the study schedule and am not currently hospitalized. I don't have severe heart valve issues, weak heart muscle, thick heart walls, or an allergy to ultrasound gel.I am 65 or older and can name a healthcare provider to get my heart monitor results.I am 40 or older and have had an ECG as part of my regular health care.
Research Study Groups:
This trial has the following groups:- Group 1: SHD Cohort
- Group 2: AF Cohort
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
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