AI-SCREENDCM Decentralized Clinical Trial - Pilot Study

Not Applicable

Recruiting

• Conditions: Cardiomyopathy
• Interventions: Diagnostic Test: KardiaRx ECG Screening

• Registration Number: NCT06609174
• Lead Sponsor: Mayo Clinic

Brief Summary

The purpose of this study is to assess the feasibility and impact of screening FDR of DCM probands using a mobile ECG with the ability to transmit the ECG for cloud-based AI analysis to detect reduced left ventricular ejection fraction (LVEF). This protocol will examine the impact of incorporating the screening AI enhanced ECG into standard of care recommendations.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2024-09-20
• Study First Submitted QC: 2024-09-20
• Study First Posted: 2024-09-24
• Study Start: 2024-10-18
• Status Verified: 2024-11
• Last Update Submitted: 2024-11-21
• Last Update Posted: 2024-11-25
• Primary Completion: 2025-10
• Study Completion: 2025-10

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 250

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SEQUENTIAL

Arm && Interventions

Group	Intervention	Description
First Degree Relative	KardiaRx ECG Screening	Subjects who are first-degree relatives of patients with DCM

Primary Outcome Measures

Name	Time	Method
Number of First-Degree Relatives to complete the AI-ECG	Baseline	Measured by the number of complete transmissions from the Kardia 6-lead device to the AI-ECG algorithm.
Number of First-Degree relatives to complete cardiac screening	Baseline	The following screening procedures will be considered a valid cardiac screening attempt: * Scheduled or Completed TTE; * Scheduled or completed clinician visit for the purposes of generating a cardiac evaluation

Secondary Outcome Measures

Name	Time	Method
Number of subjects with an Left Ventricular Ejection Fraction ≤ 45%	Baseline	Left Ventricular Ejection Fraction will be determined by AI-ECG

Trial Locations

Locations (1)

Mayo Clinic in Rochester; 🇺🇸 Rochester, Minnesota, United States