- ICH GCP
- US Clinical Trials Registry
- Klinisk forsøg NCT03731936
Artificial Intelligence to Assess the Association Between Facial Characteristics and Coronary Artery Diseases
Studieoversigt
Detaljeret beskrivelse
Several age-related appearance factors were described associated with increased risk of coronary artery diseases (CAD). However, several limitations made these facial risk factors hard to be utilized in clinical practice, including 1) low prevalence in CAD patients, 2) lack of specific definition, 3) poor reproducibility in artificial recognition.
Thus, the investigators designed a multi-center, cross-sectional study to explore the association between facial characteristics and CAD and evaluate the diagnostic efficacy of appearance factors for CAD. The investigators will recruit patients undergoing coronary angiography or coronary computer tomography angiography. Patients' baseline information and facial images will be collected. First, the investigators will explore the facial factors associated with CAD by using artificial intelligence technology to compare facial photographs between patients with CAD and without CAD. Secondary, the investigators will evaluate the dose-response relationship between facial characteristics and CAD. Third, the investigators will establish a CAD risk model based on facial factors, and evaluate the diagnostic effect of the model.
Undersøgelsestype
Tilmelding (Faktiske)
Kontakter og lokationer
Studiesteder
-
-
Beijing
-
Beijing, Beijing, Kina, 100032
- Fuwai Hospital
-
Beijing, Beijing, Kina, 100032
- Beijing Anzhen Hospital
-
Beijing, Beijing, Kina, 100032
- Guanganmen Hospital, Chinese Academy of Traditional Chinese Medicine
-
-
Hubei
-
Wuhan, Hubei, Kina, 430000
- Wuhan Union Hospital
-
-
Jiangsu
-
Xuzhou, Jiangsu, Kina, 221000
- Xuzhou Third People's Hospital
-
-
Liangning
-
Dalian, Liangning, Kina, 116000
- The First Affiliated Hospital of Dalian Medical University
-
-
Shanghai
-
Shanghai, Shanghai, Kina, 200000
- Shanghai East Hospital
-
Shanghai, Shanghai, Kina, 200000
- Shanghai Renji Hospital
-
-
Zhejiang
-
Wenzhou, Zhejiang, Kina, 325000
- The fisrt affiliated hospital of Wenzhou medical university
-
-
Deltagelseskriterier
Berettigelseskriterier
Aldre berettiget til at studere
Tager imod sunde frivillige
Køn, der er berettiget til at studere
Prøveudtagningsmetode
Studiebefolkning
Beskrivelse
Inclusion Criteria:
- Undergoing coronary angiography or coronary computer tomography angiography
- Written informed consent
Exclusion Criteria:
- Prior percutaneous coronary intervention (PCI)
- Prior coronary artery bypass graft (CABG)
- Screening coronary artery disease before treating other heart diseases
- Without blood biochemistry outcome
- With artificially facial alteration (i.e. cosmetic surgery, facial trauma or make-up)
- Other situations which make patients fail to be photographed
Studieplan
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
Kohorter og interventioner
Gruppe / kohorte |
Intervention / Behandling |
|---|---|
|
Model establishment and test group
Patients undergoing coronary angiography or coronary computer tomography angiography will be enrolled.
Patients data will be used to establish the facial based diagnostic model of coronary artery diseases, and to prospectively validate the diagnostic effectiveness of the model.
|
Ingen indgriben
|
Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
|
Sensitivity of diagnostic model
Tidsramme: at the end of enrollment (6 months)
|
The sensitivity of coronary artery diagnostic model assessed in model test group
|
at the end of enrollment (6 months)
|
Sekundære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
|
Specificity of diagnostic model
Tidsramme: at the end of enrollment (6 months)
|
The specificity of coronary artery diagnostic model assessed in model test group
|
at the end of enrollment (6 months)
|
|
Specificity of diagnostic model
Tidsramme: at the end of enrollment (6 months)
|
Area under receiver operating curve (AUC) of diagnostic model assessed in model test group
|
at the end of enrollment (6 months)
|
|
Positive predictive value (PPV)
Tidsramme: at the end of enrollment (6 months)
|
PPV of diagnostic model assessed in model test group
|
at the end of enrollment (6 months)
|
|
Negative predictive value (NPV)
Tidsramme: at the end of enrollment (6 months)
|
NPV of diagnostic model assessed in model test group
|
at the end of enrollment (6 months)
|
|
Diagnostic accuracy rate
Tidsramme: at the end of enrollment (6 months)
|
Diagnostic accuracy rate of diagnostic model assessed in model test group
|
at the end of enrollment (6 months)
|
Samarbejdspartnere og efterforskere
Datoer for undersøgelser
Studer store datoer
Studiestart (Faktiske)
Primær færdiggørelse (Faktiske)
Studieafslutning (Faktiske)
Datoer for studieregistrering
Først indsendt
Først indsendt, der opfyldte QC-kriterier
Først opslået (Faktiske)
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Faktiske)
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
Sidst verificeret
Mere information
Begreber relateret til denne undersøgelse
Yderligere relevante MeSH-vilkår
Andre undersøgelses-id-numre
- 20181104-2017-907
Plan for individuelle deltagerdata (IPD)
Planlægger du at dele individuelle deltagerdata (IPD)?
Lægemiddel- og udstyrsoplysninger, undersøgelsesdokumenter
Studerer et amerikansk FDA-reguleret lægemiddelprodukt
Studerer et amerikansk FDA-reguleret enhedsprodukt
Disse oplysninger blev hentet direkte fra webstedet clinicaltrials.gov uden ændringer. Hvis du har nogen anmodninger om at ændre, fjerne eller opdatere dine undersøgelsesoplysninger, bedes du kontakte register@clinicaltrials.gov. Så snart en ændring er implementeret på clinicaltrials.gov, vil denne også blive opdateret automatisk på vores hjemmeside .