AI-SCREENDCM Decentralized Clinical Trial - Pilot Study (NCT06609174) | Clinical Trial Compass
CompletedNot Applicable
AI-SCREENDCM Decentralized Clinical Trial - Pilot Study
United States119 participantsStarted 2024-10-18
Plain-language 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.
Who can participate
Age range18 Years
SexALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria (Proband)
* Male or female age ≥ 18 years
* Confirmed diagnosis of DCM determined at the discretion of the treating physician and defined as LVEF ≤ 45% at any time during the clinical course of the patient
* Must have at least one living ≥ 18 years FDR
* Able to provide informed consent
Inclusion Criteria (FDR)
* Male or female age ≥ 18 years who are first-degree relatives of patients with DCM
* Proband has provided informed consent
* FDR able to provide informed consent
* Access to a smartphone or digital tablet with cellular data or Wi-Fi access
Exclusion Criteria (Proband)
* DCM attributed to any other secondary form of cardiomyopathy per the investigator's determination
* Proband has previously informed FDR to undergo cardiac screening
* Ischemic cause of reduced LVEF
* evidence of myocardial infarction, inducible ischemia or chest pain on stress testing in absence of coronary angiogram to rule out ischemic disease
* history of acute coronary syndromes (STEMI, NSTEMI or unstable angina) revascularization or ≥75% stenosis of either left main or LAD or ≥75% stenosis of 2 major epicardial vessels on angiogram
* Moderate or greater primary valvular abnormality not due to underlying cardiomyopathy
* Congenital structural heart disease
* Severe and untreated or untreatable hypertension
* Cardiomyopathy due to acute or reversible conditions; examples include tachyarrhythmias, thyroid disorders, iron overload
* Any secondary cause of reduced LVEF such…
What they're measuring
1
Number of First-Degree Relatives to complete the AI-ECG
Timeframe: Baseline
2
Number of First-Degree relatives to complete cardiac screening