Computed Tomography Derived Fractional Flow Reserve for Coronary Hemodynamic Ischemia Noninvasive Assessment (CT-FFR-CHINA)
Computed Tomography Derived Fractional Flow Reserve for Coronary Hemodynamic Ischemia Noninvasive Assessment (CT-FFR-CHINA)
Studieoversikt
Status
Forhold
Detaljert beskrivelse
Numerous studies have demonstrated high diagnostic accuracy of CCTA to detect and exclude coronary artery disease (CAD). One main limitation of CCTA, however, is a tendency to overestimate the severity of coronary artery stenosis against invasive coronary angiography (ICA). On the other hand, FFR, invasively measured under ICA, is recognized as the current gold standard in determination of coronary artery lesions due to improved long-term clinical outcomes when revascularization is guided by FFR instead of ICA. Moreover, prior studies indicated unreliable relationships between detection of obstructive anatomic coronary artery stenoses defined by CCTA and hemodynamically significant lesions by invasive fractional flow reserve (FFR).
Recent advances in artificial intelligence and computational modeling techniques now permit construction of a 3-dimensional model of coronary arteries visible from CCTA images and computation of FFR anywhere in the entire 3D model noninvasively. Several prior prospective, multicenter studies have reported promising results for the diagnostic performance of CT-FFR using invasive FFR as the reference standard. However, the diagnostic performance of CT-FFR in Chinese population is not clear. Therefore, we hereby designed the CT-FFR-CHINA study to determine the hemodynamically significant lesions, exclusively in Chinese subjects. It is a prospective and multi-center trial with a total of 326 subjects enrolled at 4 Chinese centers.
Studietype
Registrering (Forventet)
Kontakter og plasseringer
Studiesteder
-
-
Beijing
-
Beijing, Beijing, Kina
- Fuwai Hospital
-
Ta kontakt med:
- Bin Lu, MD
-
Beijing, Beijing, Kina
- Chao-Yang Hospital
-
Ta kontakt med:
- Tao Jiang, MD
-
-
Shandong
-
Jinan, Shandong, Kina
- Qi Lu Hospital, Shan Dong University
-
Ta kontakt med:
- Wenqiang Chen, MD
-
-
Zhejiang
-
Hangzhou, Zhejiang, Kina
- Sir Run Run Shaw Hospital, Zhe Jiang University School of Medicine
-
Ta kontakt med:
- Hongjie Hu, MD
-
-
Deltakelseskriterier
Kvalifikasjonskriterier
Alder som er kvalifisert for studier
Tar imot friske frivillige
Kjønn som er kvalifisert for studier
Prøvetakingsmetode
Studiepopulasjon
Beskrivelse
Inclusion Criteria:
General Criteria:
- Stable and unstable angina pectoris or secondary evaluation of stenosis after acute MI
- Age > 18 years
- Able to provide signed informed consent
CCTA inclusion criteria:
- At least one stenosis with diameter stenosis of 30%-90% by visual estimate
- Reference vessel size > 2 mm in stenotic segment by visual estimate
Exclusion Criteria:
General Criteria:
- Ineligible for diagnostic intervention or FFR examination
- Myocardial infarction within 72 hours
- Severe heart failure (NYHA≥III)
- S-creatinine>150µmol/L or GFR<45 ml/kg/1.73m2
- Allergy to contrast agent or adenosine
- Factors that might substantially impact the CCTA image quality, e.g, frequent atrial premature beat or atrial fibrillation
Angiographic exclusion criteria:
- The interrogated stenosis is caused by myocardial bridge
- Ostial lesions less than 3 mm to the aorta
- Poor angiographic image quality precluding contour detection
- Severe overlap of stenotic segments
- Severe tortuosity of target vessel
Studieplan
Hvordan er studiet utformet?
Designdetaljer
Hva måler studien?
Primære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
|
sensitivity and specificity of CT-FFR compared with CCTA
Tidsramme: 7days
|
In comparison to CCTA, sensitivity and specificity of CT-FFR determine whether a subject has hemodynamically-significant coronary artery lesions using binary outcomes when compared to invasive FFR as the reference standard.
|
7days
|
Sekundære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
|
accuracy, positive predictive value, negative predictive value of CT-FFR compared with CCTA
Tidsramme: 7days
|
In comparison to CCTA, accuracy, positive predictive value, negative predictive value of CT-FFR to determine whether a subject has hemodynamically-significant coronary artery lesions using binary outcomes when compared to invasive FFR as the reference standard
|
7days
|
|
the area under the receiver operating characteristic curve of CT-FFR compared with CCTA
Tidsramme: 7days
|
In comparison to CCTA, the area under the receiver operating characteristic curve of CT-FFR in determining whether a subject has hemodynamically-significant coronary artery lesions using binary outcomes when compared to invasive FFR as the reference standard
|
7days
|
Samarbeidspartnere og etterforskere
Samarbeidspartnere
Publikasjoner og nyttige lenker
Generelle publikasjoner
- Gao Y, Zhao N, Song L, Hu H, Jiang T, Chen W, Zhang F, Dou K, Mu C, Yang W, Fu G, Xu L, Li D, Fan L, An Y, Wang Y, Li W, Xu B, Lu B. Diagnostic Performance of CT FFR With a New Parameter Optimized Computational Fluid Dynamics Algorithm From the CT-FFR-CHINA Trial: Characteristic Analysis of Gray Zone Lesions and Misdiagnosed Lesions. Front Cardiovasc Med. 2022 Mar 22;9:819460. doi: 10.3389/fcvm.2022.819460. eCollection 2022.
- Gao Y, Zhao N, Song L, Hu F, Mu C, Gao L, Cui J, Yin D, Yang W, Xu B, Lu B. Diastolic versus systolic coronary computed tomography angiography derived fractional flow reserve for the identification of lesion-specific ischemia. Eur J Radiol. 2022 Feb;147:110098. doi: 10.1016/j.ejrad.2021.110098. Epub 2021 Dec 14.
Studierekorddatoer
Studer hoveddatoer
Studiestart (Forventet)
Primær fullføring (Forventet)
Studiet fullført (Forventet)
Datoer for studieregistrering
Først innsendt
Først innsendt som oppfylte QC-kriteriene
Først lagt ut (Faktiske)
Oppdateringer av studieposter
Sist oppdatering lagt ut (Faktiske)
Siste oppdatering sendt inn som oppfylte QC-kriteriene
Sist bekreftet
Mer informasjon
Begreper knyttet til denne studien
Ytterligere relevante MeSH-vilkår
Andre studie-ID-numre
- CNCCD
Legemiddel- og utstyrsinformasjon, studiedokumenter
Studerer et amerikansk FDA-regulert medikamentprodukt
Studerer et amerikansk FDA-regulert enhetsprodukt
Denne informasjonen ble hentet direkte fra nettstedet clinicaltrials.gov uten noen endringer. Hvis du har noen forespørsler om å endre, fjerne eller oppdatere studiedetaljene dine, vennligst kontakt register@clinicaltrials.gov. Så snart en endring er implementert på clinicaltrials.gov, vil denne også bli oppdatert automatisk på nettstedet vårt. .
Kliniske studier på Koronararteriesykdom
-
IRCCS Policlinico S. DonatoRekrutteringAnomalous aortic origin of the coronary artery (AAOCA)Italia
-
Medtronic CardiovascularFullførtArteriosclerosis of coronary artery bypass graftCanada, Forente stater
-
Lawson Health Research InstituteFullførtArteriosclerosis of arterial coronary artery bypass graftCanada
-
Deutsches Herzzentrum MuenchenFullførtArteriosclerosis of arterial coronary artery bypass graftTyskland
-
William Beaumont HospitalsFullførtKoronararteriesykdom | Arteriosclerosis of coronary artery bypass graftForente stater
-
Izmir Bakircay UniversityFullførtMyocardial Bridge of Coronary ArteryTyrkia
-
ITAB - Institute for Advanced Biomedical TechnologiesAzienda Ospedaliero, Universitaria Ospedali RiunitiFullførtMyocardial Bridge of Coronary ArteryItalia
-
University Hospital OstravaRekrutteringIn-Stent Carotis Artery RestenosisTsjekkia
-
Sohag UniversityHar ikke rekruttert ennåUmblical artery Doppler under termin graviditetEgypt
-
Baylor College of MedicineFullførtLungeblødning | MAPCA - Major Aortopulmonary Collateral ArteryForente stater