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- Registre américain des essais cliniques
- Essai clinique NCT02499679
Assessing Diagnostic Value of Non-invasive FFRCT in Coronary Care (ADVANCE)
Assessing Diagnostic Value of Non-invasive FFRCT in Coronary CarE (ADVANCE)
Aperçu de l'étude
Statut
Les conditions
Description détaillée
REGISTRY OBJECTIVE
The objective of the HeartFlow ADVANCE Registry is to evaluate utility, clinical outcomes and resource utilization of FFRCT-guided evaluation in clinically stable, symptomatic patients with CAD in order to further inform patients, health care providers, and other stakeholders about which technologies are most effective and efficient in the diagnosis and management of CAD.
SPECIFIC OBJECTIVES:
- To determine if the availability of FFRCT, in addition to coronary anatomy from the cCTA, will lead to a significant change in the coronary management plan.
- To assess the real world outcomes of utilizing FFRCT to guide invasive management and/or medical treatment.
- To assess resource utilization, following standard practice for diagnostic and treatment pathways incorporating FFRCT as the preferred CAD diagnostic test.
- To provide society including patients, health care providers, and other stakeholders with information about which diagnostic technologies are most effective and efficient in managing patients with CAD.
Type d'étude
Inscription (Réel)
Critères de participation
Critère d'éligibilité
Âges éligibles pour étudier
Accepte les volontaires sains
Sexes éligibles pour l'étude
Méthode d'échantillonnage
Population étudiée
La description
Inclusion Criteria:
- Provide written informed consent
- Clinically stable, symptomatic patients who undergo cCTA and are diagnosed with CAD and meet eligibility criteria for FFRCT.
Exclusion Criteria:
- cCTA showing no CAD
- Uninterpretable cCTA by site assessment, in which severe artifacts prevent angiographic evaluation
- Any active, serious, life-threatening disease with a life expectancy of less than 1 year
- Inability to comply with follow-up requirements
Plan d'étude
Comment l'étude est-elle conçue ?
Détails de conception
- Modèles d'observation: Cas uniquement
- Perspectives temporelles: Éventuel
Cohortes et interventions
Groupe / Cohorte |
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Patients diagnosed with CAD by cCTA
All clinically stable, symptomatic patients diagnosed with CAD by coronary computed tomography angiography (cCTA), that meet eligibility criteria, and are able and willing to participate are candidates for the ADVANCE Registry.
Those patients that meet all inclusion/exclusion criteria and who sign the ethics committee (EC)/institutional review board (IRB) approved informed consent will be enrolled in the registry.
FFRCT shall be used in accordance with the current Instructions for Use (IFU) document.
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Que mesure l'étude ?
Principaux critères de jugement
Mesure des résultats |
Délai |
---|---|
Reclassification rate between the coronary management plan based on the review of the cCTA compared to the management plan based on FFRCT when obtained, as assessed by an independent review committee.
Délai: n/a: reclassification rate of management plan
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n/a: reclassification rate of management plan
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Mesures de résultats secondaires
Mesure des résultats |
Description de la mesure |
Délai |
---|---|---|
Rate of reclassification between Investigator management plan based on cCTA alone compared to actual clinical management
Délai: 90 days
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90 days
|
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Rate of invasive catheterization without obstructive disease
Délai: 90 days
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90 days
|
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Percent of patients undergoing revascularization within 90 days for whom functional data are available prior to revascularization
Délai: 90 days
|
90 days
|
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Major Adverse Coronary Event (MACE) rates at 90 days, 180 days and 1 - 3 years
Délai: 3 years
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MACE is defined as the composite rate of all cause death, non-fatal myocardial infarction (MI) and unplanned hospitalization for acute coronary syndrome (ACS) leading to urgent revascularization.
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3 years
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Individual components of MACE at 90 days, 180 days, 1 - 3 years
Délai: 3 years
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Individual components of MACE defined as all cause death, non-fatal MI, unplanned hospitalization for ACS leading to urgent revascularization
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3 years
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Estimated cumulative medical radiation exposure
Délai: 1 year
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1 year
|
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Resource Utilization at 90 days, 180 days, 1 - 3 years
Délai: 3 years
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Resource utilization composite defined as the composite of invasive diagnostic and therapeutic coronary procedures, treatment of MACE events, and noninvasive cardiac testing
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3 years
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Collaborateurs et enquêteurs
Parrainer
Les enquêteurs
- Chercheur principal: Manesh Patel, MD, Duke Health
- Chercheur principal: Jonathon Leipsic, MD, Providence Health & Services
- Chercheur principal: Koen Nieman, MD, Erasmus Medical Center
- Chercheur principal: Takashi Akasaka, MD, Wakayama Medical University
Publications et liens utiles
Publications générales
- Fairbairn TA, Dobson R, Hurwitz-Koweek L, Matsuo H, Norgaard BL, Ronnow Sand NP, Nieman K, Bax JJ, Pontone G, Raff G, Chinnaiyan KM, Rabbat M, Amano T, Kawasaki T, Akasaka T, Kitabata H, Binukrishnan S, Rogers C, Berman D, Patel MR, Douglas PS, Leipsic J. Sex Differences in Coronary Computed Tomography Angiography-Derived Fractional Flow Reserve: Lessons From ADVANCE. JACC Cardiovasc Imaging. 2020 Dec;13(12):2576-2587. doi: 10.1016/j.jcmg.2020.07.008. Epub 2020 Aug 26.
- Pontone G, Weir-McCall JR, Baggiano A, Del Torto A, Fusini L, Guglielmo M, Muscogiuri G, Guaricci AI, Andreini D, Patel M, Nieman K, Akasaka T, Rogers C, Norgaard BL, Bax J, Raff GL, Chinnaiyan K, Berman D, Fairbairn T, Koweek LH, Leipsic J. Determinants of Rejection Rate for Coronary CT Angiography Fractional Flow Reserve Analysis. Radiology. 2019 Sep;292(3):597-605. doi: 10.1148/radiol.2019182673. Epub 2019 Jul 23.
- Patel MR, Norgaard BL, Fairbairn TA, Nieman K, Akasaka T, Berman DS, Raff GL, Hurwitz Koweek LM, Pontone G, Kawasaki T, Sand NPR, Jensen JM, Amano T, Poon M, Ovrehus KA, Sonck J, Rabbat MG, Mullen S, De Bruyne B, Rogers C, Matsuo H, Bax JJ, Leipsic J. 1-Year Impact on Medical Practice and Clinical Outcomes of FFRCT: The ADVANCE Registry. JACC Cardiovasc Imaging. 2020 Jan;13(1 Pt 1):97-105. doi: 10.1016/j.jcmg.2019.03.003. Epub 2019 Mar 17.
Dates d'enregistrement des études
Dates principales de l'étude
Début de l'étude (Réel)
Achèvement primaire (Réel)
Achèvement de l'étude (Réel)
Dates d'inscription aux études
Première soumission
Première soumission répondant aux critères de contrôle qualité
Première publication (Estimation)
Mises à jour des dossiers d'étude
Dernière mise à jour publiée (Réel)
Dernière mise à jour soumise répondant aux critères de contrôle qualité
Dernière vérification
Plus d'information
Termes liés à cette étude
Termes MeSH pertinents supplémentaires
Autres numéros d'identification d'étude
- CP-905-001
Informations sur les médicaments et les dispositifs, documents d'étude
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