Trial Radar AI | ||
|---|---|---|
De klinische studie NCT07486271 voor Aortic Regurgitation Disease is rekruterend. Bekijk de kaartweergave van de Klinische Studies Radar en de AI-ontdekkingstools voor alle details. Of stel hier een vraag. | ||
Eén studie komt overeen met de filtercriteria
Kaartweergave
Terug naar zoekresultaten
Chinese University of Hong KongArtificial Intelligence in Aortic Regurgitation 540 Gerandomiseerd
Informatie over klinische studies is voornamelijk in het Engels beschikbaar. Trial Radar AI kan echter helpen! Klik op 'Leg studie uit' om de informatie over de studie te bekijken en te bespreken in de taal van uw keuze.
De klinische studie NCT07486271 is een interventioneel studie bij Aortic Regurgitation Disease met de status rekruterend. Het doel is om 540 deelnemers te includeren vanaf 1 december 2025. De studie wordt geleid door Chinese University of Hong Kong en de voltooiing is gepland op 31 maart 2028. Laatste update op ClinicalTrials.gov: 20 maart 2026.
Beknopte samenvatting
This research project aims to develop and validate a tool that uses artificial intelligence (AI) to automatically detect and quantify aortic regurgitation (AR). The clinical efficacy of this tool will be established by comparing it to manual diagnostic methods in a multicenter randomized controlled trial. By leveraging deep learning (DL) techniques, the AI system will automate aortic regurgitation (AR) detection, mea...Toon meer
Officiële titel
Artificial Intelligence in Aortic Regurgitation: A Multicenter Randomised Controlled Trial
Aandoeningen
Aortic Regurgitation DiseaseAndere studie-ID's
- 2024.689-T
NCT-ID
Startdatum (Werkelijk)
2025-12-01
Laatste update geplaatst
2026-03-20
Verwachte einddatum
2028-03-31
Inschrijving (Geschat)
540
Studietype
Interventioneel
FASE
N.v.t.
Status
Rekruterend
Trefwoorden
Aortic Regurgitation
Artificial Intelligence
Echocardiography
Automated Diagnosis
Clinical Efficacy
Artificial Intelligence
Echocardiography
Automated Diagnosis
Clinical Efficacy
Primaire doel
Diagnostisch
Toewijzing
Gerandomiseerd
Interventiemodel
Parallel
Blindering
Dubbelblind
Armen / Interventies
| Deelnemersgroep/Studiearm | Interventie/Behandeling |
|---|---|
Actieve comparatorAI-Assisted Group AR severity will be assessed using an AI tool that evaluates grading and key echocardiographic parameters (e.g., EROA, VC, PISA, jet width, and RegVol), along with the time required for assessments. | AI-Assisted Group Participants in this group will undergo aortic regurgitation assessment using an advanced artificial intelligence tool. |
OverigeManual Measurement Group AR severity will be assessed manually by trained sonographers following standard protocols. Cardiologists (ASE level III or equivalent), blinded to patient history and group assignment, will review both AI-generated and manual outputs to make final diagnoses and treatment decisions based solely on the initial assessments. | Manual measurement group Participants in this group will receive a traditional diagnostic assessment for aortic regurgitation, performed by trained sonographers following standard protocols. |
Primaire uitkomst
Secundaire uitkomst
| Uitkomstmaat | Beschrijving van de uitkomstmaat | Tijdsbestek |
|---|---|---|
Study Outcomes | To compare the accuracy of the AI group and the manual group in distinguishing severe from non-severe AR, using expert cardiologists' (ASE level III or equivalent) assessments as the reference standard. | This will be recorded from baseline to study completion (20 months) |
| Uitkomstmaat | Beschrijving van de uitkomstmaat | Tijdsbestek |
|---|---|---|
Comparing Accuracy in Differentiating AR Severity Levels | To compare the accuracy of the AI group and the manual group in differentiating trace, mild, moderate, and severe aortic regurgitation, using cardiologists' assessments as the reference standard. | This will be recorded from baseline to study completion (20 months) |
Assessing deviations in Effective Regurgitant Orifice Area (EROA) | The Effective Regurgitant Orifice Area (EROA) assesses the size of a valve opening that leads to backward blood flow in the heart. It is an important metric for evaluating valvular regurgitation and will be measured during echocardiography. | This will be recorded from baseline to study completion (20 months) |
Assessing deviations in Vena Contracta (VC) | The Vena Contracta (VC) is an important measurement in echocardiography used to evaluate how severe mitral regurgitation is and will be measured during echocardiography. | This will be recorded from baseline to study completion (20 months) |
Assessing deviations in Proximal Isovelocity Surface Area (PISA) | Proximal Isovelocity Surface Area (PISA) is a method used in echocardiography to evaluate mitral regurgitation and will be measured during echocardiography. | This will be recorded from baseline to study completion (20 months) |
Assessing deviations in jet width | The jet width is a critical measurement used to assess the severity of aortic regurgitation and will be measured during echocardiography. | This will be recorded from baseline to study completion (20 months) |
Assessing deviations in Regurgitant Volume (RegVol) | Regurgitant Volume assesses how much blood leaks back into the left atrium during mitral regurgitation and will be measured using Doppler echocardiography. | This will be recorded from baseline to study completion (20 months) |
Comparing Assessment Completion Time | To compare the time taken by the AI group, the manual group, and the cardiologists to complete their assessments. | The time taken for each method to reach a diagnosis will be recorded from baseline to study completion (20 months) |
Tracking 1-Year Outcomes | To track 1-year all-cause mortality and heart failure hospitalizations (HFH), comparing outcomes for patients with severe aortic regurgitation identified by the AI and manual groups, separately. | Participants will be followed up at 6 and 12 months to monitor outcomes, including 1-year all-cause mortality and HFH. |
Deelname-assistent
Geschiktheidscriteria
Leeftijd van deelnemers
Volwassene, Oudere volwassene
Minimumleeftijd
18 Years
Geslachten die in aanmerking komen voor de studie
Allen
- Confirmed AR diagnosis via TTE and Doppler imaging per guidelines.
- Age ≥ 18 years.
- Adequate acoustic window for AR quantification.
- Prior cardiac transplant or implanted cardiac devices.
- Poor image quality.
- Pregnancy or lactation.
Chinese University of Hong Kong474 actieve klinische studies om te verkennen- 🎓Semmelweis U...
Verantwoordelijke instantie
Dr Alex PW Lee, Hoofdonderzoeker, Professor, Chinese University of Hong Kong
Centraal Contactpersoon
Contact: Xueting Wang, (852) 3505 3840, [email protected]
1 Studielocaties in 1 landen
New Territories
Division of Cardiology, Department of Medicine and Therapeutics Faculty of Medicine, The Chinese University of Hong Kong, Hong Kong, New Territories, Sha Tin, Hong Kong
Xueting PW Wang, Professor, Contact, (852) 3505 3840, [email protected]
Rekruterend