Your session is about to expire
← Back to Search
AI-Enhanced ECG Screening for Cardiomyopathy
N/A
Recruiting
Led By Naveen Pereira, M.D.
Research Sponsored by Mayo Clinic
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Proband: Confirmed diagnosis of DCM with LVEF ≤ 45%
Proband: Must have at least one living ≥ 18 years first-degree relative
Must not have
Proband: Cardiomyopathy due to acute or reversible conditions
Proband: Moderate or greater primary valvular abnormality not due to underlying cardiomyopathy
Timeline
Screening 3 weeks
Treatment Varies
Follow Up baseline
Awards & highlights
No Placebo-Only Group
Summary
This trial aims to see if using a mobile ECG device to screen family members of individuals with Dilated Cardiomyopathy (DCM) can help detect heart issues. The ECG results will
Who is the study for?
This trial is for first-degree relatives (FDR) of individuals with dilated cardiomyopathy (DCM), aiming to detect early heart function issues using a mobile ECG device. Participants should be willing to use the device and transmit data for analysis.
What is being tested?
The study tests the KardiaRx ECG Screening's effectiveness in identifying reduced left ventricular ejection fraction, an indicator of potential heart problems, compared to standard care which includes screening with an echocardiogram.
What are the potential side effects?
Since this trial involves non-invasive ECG monitoring, there are minimal risks associated. Potential side effects may include discomfort or skin irritation from wearing the ECG device.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I have been diagnosed with dilated cardiomyopathy and my heart's pumping efficiency is 45% or less.
Select...
I have a living relative who is 18 or older and closely related to me.
Select...
I am 18 years old or older.
Exclusion Criteria
You may be eligible for the trial if you check “No” for criteria below:Select...
My heart muscle disease was caused by a sudden or reversible condition.
Select...
My heart valve issue is not caused by a heart muscle disease.
Select...
I was born with a heart defect.
Select...
I have severe high blood pressure that hasn't been treated or can't be treated.
Select...
My low heart function is not due to pregnancy, inflammation, or exposure to toxins.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ baseline
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~baseline
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
Number of First-Degree Relatives to complete the AI-ECG
Number of First-Degree relatives to complete cardiac screening
Secondary study objectives
Number of subjects with an Left Ventricular Ejection Fraction ≤ 45%
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: First degree relativesExperimental Treatment1 Intervention
Subjects who are first-degree relatives of patients with DCM
Group II: DCM (Dilated Cardiomyopathy) PatientsExperimental Treatment1 Intervention
Subjects who are diagnosed with DCM (dilated cardiomyopathy).
Find a Location
Who is running the clinical trial?
Mayo ClinicLead Sponsor
3,362 Previous Clinical Trials
3,065,711 Total Patients Enrolled
5 Trials studying Cardiomyopathy
1,459 Patients Enrolled for Cardiomyopathy
Naveen Pereira, M.D.Principal InvestigatorMayo Clinic
1 Previous Clinical Trials
101 Total Patients Enrolled