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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 weeks
Treatment ~ Varies
Follow Up ~1 year
This trial's timeline: 3 weeks for screening, Varies for treatment, and 1 year for reporting.

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
3,339 Previous Clinical Trials
3,042,002 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

Notification of the AI ECG algorithm and the A3E scores Clinical Trial Eligibility Overview. Trial Name: NCT05557162 — N/A
Cardiac Amyloidosis Research Study Groups: Notification of the AI ECG algorithm and the A3E scores, Usual Care
Cardiac Amyloidosis Clinical Trial 2023: Notification of the AI ECG algorithm and the A3E scores Highlights & Side Effects. Trial Name: NCT05557162 — N/A
Notification of the AI ECG algorithm and the A3E scores 2023 Treatment Timeline for Medical Study. Trial Name: NCT05557162 — N/A
~8335 spots leftby Dec 2025
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