BefejeződöttFázis nélkül
AI-SCREENDCM Decentralized Clinical Trial - Pilot Study
A legfontosabb adatok
- Ki végzi
- Mayo Clinic
- Hol
- Rochester (Egyesült Államok)A helyszín megnézése
- Azonosító
- Állapot
- Befejeződött
- Résztvevők
- 119 fő vett részt
- Kezdés
- 2024. okt. 18.
- Befejezés
- 2025. szept. 26.
- A vizsgálat típusa
- Beavatkozással járó, 2 csoport
- A vizsgált kezelések
- KardiaRx ECG Screening and AI interpretation of ECG
- A regiszteradat frissítve
- 2026. október 13.
Ki vehet részt
- Életkor
- 18 év felett
- Nem
- Nők és férfiak
- Egészséges önkéntesek
- Nem vehetnek részt
A regiszter feltételei, szó szerint
Mind a 20 feltétel megnézéseKevesebb
Ki vehet részt
- 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
- 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
Ki nem vehet részt
- Proband has previously informed FDR to undergo cardiac screening
- Previously informed about cardiac screening or has completed cardiac screening by TTE
- Congenital structural heart disease
- Severe and untreated or untreatable hypertension
- Cardiomyopathy due to acute or reversible conditions; examples include tachyarrhythmias, thyroid disorders, iron overload
- 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
- Any secondary cause of reduced LVEF such as peripartum cardiomyopathy, myocarditis, amyloidosis, sarcoidosis, exposure to toxins including alcohol, substance abuse or chemotherapeutic drug
- Previously diagnosed with reduced LVEF
- DCM attributed to any other secondary form of cardiomyopathy per the investigator's determination
- Moderate or greater primary valvular abnormality not due to underlying cardiomyopathy
- (CPC Participants only) Home address outside of traveling range
- (CPC Participants only) Home address outside of traveling range
Helyszínek itt: Egyesült Államok
- Mayo Clinic in RochesterRochester, Egyesült ÁllamokNo longer taking part
A vizsgálatról
Mit akar kideríteni a vizsgálat
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.
A vizsgálat 2 csoportja
- First degree relativesA vizsgált kezelés
Subjects who are first-degree relatives of patients with DCM
Kezelés: KardiaRx ECG Screening and AI interpretation of ECG
- DCM (Dilated Cardiomyopathy) PatientsA vizsgált kezelés
Subjects who are diagnosed with DCM (dilated cardiomyopathy).
Kezelés: KardiaRx ECG Screening and AI interpretation of ECG
Adatok és források
- Regiszteradat
- Szerepel a ClinicalTrials.gov-on.
- Hivatalos cím
- Artificial Intelligence Electrocardiogram Enabled Mobile Device in Screening Families for Dilated Cardiomyopathy (The AI-SCREENDCM Decentralized Clinical Trial Pilot Study)
- A regiszteradat frissítve
- 2026. október 13.