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AI Screening

AI-Driven EKG Screening for Dilated Cardiomyopathy (DCM-DETECT Trial)

N/A

Waitlist Available

Led By Roy Small, MD

Research Sponsored by Lancaster General Hospital

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Proband: Male or female age ≥ 18 years

Proband: Confirmed diagnosis of non-ischemic DCM with LVEF ≤ 45%

Must not have

Proband: Congenital structural heart disease

Proband: Cardiomyopathy due to acute or reversible conditions

Timeline

Screening 3 weeks

Treatment Varies

Follow Up assessed at 3 months post enrollment check-in or 6 months post enrollment check-in if not completed by 3 months.

Awards & highlights

No Placebo-Only Group

Summary

This trial will invite family members of patients with dilated cardiomyopathy to undergo a screening test for heart conditions using a mobile device.

Who is the study for?

This trial is for people with dilated cardiomyopathy who will invite their close family members to participate in mobile heart screening using an AI-enhanced electrocardiogram (EKG).

What is being tested?

The study is testing a new way to detect heart conditions using a portable device that records the electrical activity of the heart, enhanced by artificial intelligence.

What are the potential side effects?

Since this trial involves non-invasive EKG screening, there are minimal risks involved. Participants may experience minor discomfort from the adhesive electrodes or anxiety about test results.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I am 18 years old or older.

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I have been diagnosed with a type of heart failure not caused by blocked arteries and my heart's pumping ability is reduced.

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I have at least one living adult close family member.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I was born with a heart defect.

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My heart condition is due to a sudden or treatable cause.

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I have a significant heart valve problem not caused by heart muscle disease.

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My low heart pumping function is due to a blockage.

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I have severe high blood pressure that hasn't been treated or can't be treated.

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I have a condition that has caused my heart's pumping ability to decrease.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ assessed at 3 months post enrollment check-in or 6 months post enrollment check-in if not completed by 3 months.

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~assessed at 3 months post enrollment check-in or 6 months post enrollment check-in if not completed by 3 months.

This trial's timeline: 3 weeks for screening, Varies for treatment, and assessed at 3 months post enrollment check-in or 6 months post enrollment check-in if not completed by 3 months. for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

This study's primary endpoint is to assess the feasibility of performing AI-EKG test and the subsequent uptake of cardiac screening in FDR of DCM patients.

Secondary study objectives

To detect LVEF ≤ 45% by AI-EKG among FDR of DCM probands.

Other study objectives

Identify barriers to adoption of AI technology, variables that contribute to the reluctance to participate, and logistical barriers to research utilizing "decline to participate" surveys.

To assess the concordance of 6-Lead (6L) Kardia AI EKG with 12-Lead (12L) EKG, if available, to detect reduced LVEF in DCM probands.

To detect LVEF ≤ 45% by subsequent cardiac screening among FDR of DCM probands.

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

1Treatment groups

Experimental Treatment

Group I: DCM ScreeningExperimental Treatment1 Intervention

Participants with dilated cardiomyopathy will invite their first-degree relatives to participate in DCM screening to examine the impact of an "Artificial Intelligent" (AI) enhanced 6lead (6L) mobile EKG in encouraging first degree relatives (FDR) of probands with a dilated cardiomyopathy (DCM) to obtain appropriate cardiac screening.

0 / 9Eligibility criteria met