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AI-Enhanced ECG for Cardiac Amyloidosis
N/A
Waitlist Available
Led By Angela Dispenzieri, MD
Research Sponsored by Mayo Clinic
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 1 year
Awards & highlights
No Placebo-Only Group
Summary
This trial assesses whether a new AI-based tool can improve the diagnosis of cardiac amyloidosis, a heart condition.
Who is the study for?
This trial is for Mayo Clinic providers who agree to participate and are involved in caring for adult patients within cardiology or hematology departments. There are no specific exclusion criteria, making it broadly accessible to these healthcare professionals.
What is being tested?
The study is evaluating an innovative AI-powered tool that analyzes ECG readings to help detect cardiac amyloidosis more effectively. This could potentially improve diagnosis rates of this heart condition.
What are the potential side effects?
Since the intervention involves using an AI algorithm on ECG data rather than a medical treatment or drug, there are no direct side effects associated with its use in this trial.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 1 year
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~1 year
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
To determine if AI ECG algorithm and enhanced algorithms and education enable earlier diagnosis of cardiac amyloidosisProtocol for a Pragmatic Cluster Randomized Clinical Trial (PREDICT-AMY)
Secondary study objectives
To assess differential costs between the intervention arm and the standard of care arm
Electrocardiogram
Electrocardiogram
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
Active Control
Group I: Notification of the AI ECG algorithm and the A3E scoresExperimental Treatment1 Intervention
Provider-facing recommendation report that alerts to provider for positive AI ECG Amyloid Score, standardized amyloid order set, diagnostic algorithm and reminders
Group II: Usual CareActive Control1 Intervention
No alerts to provider for positive AI ECG Amyloid Score, standardized amyloid order set, diagnostic algorithm and reminders
Find a Location
Who is running the clinical trial?
Mayo ClinicLead Sponsor
3,351 Previous Clinical Trials
3,040,814 Total Patients Enrolled
1 Trials studying Cardiac Amyloidosis
100 Patients Enrolled for Cardiac Amyloidosis
Angela Dispenzieri, MDPrincipal InvestigatorMayo Clinic
3 Previous Clinical Trials
156 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I am under the care of a Mayo Clinic cardiologist or hematologist.N/A
Research Study Groups:
This trial has the following groups:- Group 1: Notification of the AI ECG algorithm and the A3E scores
- Group 2: Usual Care
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.