Impact of Stress CT Myocardial Perfusion on Downstream Resources and Prognosis (CTP-PRO)
4 de junio de 2019 actualizado por: Gianluca Pontone, MD, PhD, Centro Cardiologico Monzino
Impact of Stress Cardiac Computed Tomography Myocardial Perfusion on Downstream Resources and PROgnosis in Patients With Suspected or Known Coronary Artery Disease: a Multicenter International Study
CT myocardial perfusion imaging (CTP) represents one of the newly developed CT-based techniques but its cost-effectiveness in the clinical pathway is undefined.
The aim of the study is to evaluate the usefulness of combined evaluation of coronary anatomy and myocardial perfusion in intermediate to high-risk patients for suspected CAD or with known disease in terms of clinical decision-making, resource utilization and outcomes in a broad variety of geographic areas and patient subgroups.
Descripción general del estudio
Estado
Desconocido
Descripción detallada
The use of cardiac computed tomography angiography (CCTA) is usually suggested in low to intermediate risk for its diagnostic and prognostic role to rule out CAD with low radiation exposure. In the setting of intermediate to high risk patients, the addition of functional information is prognostically useful and, in patients with previous history of percutaneous coronary intervention (PCI), functional strategy has been shown to be more cost-effective as compared to anatomical assessment CT myocardial perfusion imaging (CTP) represents one of the newly developed CT-based techniques, combining both anatomical and functional evaluation of CAD in a single imaging modality. More recently, stress CTP was shown to provide additional diagnostic value as compared to CCTA alone in intermediate to high risk patients. The purpose of this study will be to evaluate the usefulness and impact of combined evaluation of coronary artery anatomy and myocardial perfusion with CCTA+CTP in intermediate to high risk patients for suspected CAD or with known disease in terms of clinical decision-making, resource utilization, and outcomes in a broad variety of geographic areas and patient subgroups.
CTP-PRO study is a cooperative, international, multicentre, prospective, open-label, randomized controlled study evaluating the cost-effectiveness of a CCTA+CTP strategy versus usual care in intermediate to high risk patients with suspected or known CAD who undergo clinically indicated diagnostic evaluation.
Patients will be screened for study eligibility. Patients meeting all selection criteria will be asked to sign an informed consent document prior to undergoing any study-specific evaluation; then a structured interview will be performed and a clinical history obtained, assessing the presence of common cardiac risk factors, drug therapy (focus on statin, aspirin and/or antiplatelet agent use) and symptoms (typical or atypical angina, to estimate the pre-test likelihood of CAD).
Upon completion of the screening procedure and enrollment, the patients will be randomized 1:1 to the CT-based strategy (Group A) or usual care (Group B). Patient follow-up will be performed at 1 year (± 1 month) and 2 years (± 1 month) by trained interviewers who check medical records or by phone interview collecting the following information: downstream testing; overall radiation exposure; outcomes; cost-effectiveness estimation.
The primary endpoint of the study is the reclassification rate of CCTA in group B due to the addition of CTP. The secondary endpoint will be the comparison between group A and group B in terms of non-invasive and invasive downstream testing, prevalence of obstructive CAD at ICA, revascularization, cumulative ED and overall cost during the follow-up at 1- and 2-years. The tertiary endpoint will be the comparison between each group in terms of MACE and cost-effectiveness at 1- and 2-years.
Tipo de estudio
Intervencionista
Inscripción (Anticipado)
2000
Fase
- No aplica
Contactos y Ubicaciones
Esta sección proporciona los datos de contacto de quienes realizan el estudio e información sobre dónde se lleva a cabo este estudio.
Estudio Contacto
- Nombre: Gianluca Pontone, MD, PhD
- Número de teléfono: 00300258002574
- Correo electrónico: gianluca.pontone@ccfm.it
Criterios de participación
Los investigadores buscan personas que se ajusten a una determinada descripción, denominada criterio de elegibilidad. Algunos ejemplos de estos criterios son el estado de salud general de una persona o tratamientos previos.
Criterio de elegibilidad
Edades elegibles para estudiar
18 años y mayores (Adulto, Adulto Mayor)
Acepta Voluntarios Saludables
No
Géneros elegibles para el estudio
Todos
Descripción
Inclusion Criteria:
- Consecutive patients (age ≥ 18 years) with known or suspected CAD referred for clinically indicated diagnostic evaluation.
- CCTA has to be performed with the state of art in terms of scanner technology as follow: Revolution CT (GE Healthcare, Milwaukee, WI), CardioGraphe (Arineta, Caesarea, Israel), SOMATOM Force (Siemens, Forchheim, Germany), Brilliance iCT and IQon CT (Philips, Best, Netherlands), Aquilion One Vision (Toshiba Medical Systems Corp., Otawara, Japan).
Exclusion Criteria:
- Performance of any non-invasive diagnostic testing within 90 days before enrollment
- Low to intermediate pre-test likelihood of CAD according to the updated Diamond-Forrester risk model score
- Acute coronary syndrome
- Need for an emergent procedure
- Evidence of clinical instability
- Contra-indication to contrast agent administration and/or impaired renal function
- Inability to sustain a breath hold
- Pregnancy
- Cardiac arrhythmias
- Presence of pace maker or implantable cardioverter defibrillator
- Contra-indications to the administration of sub-lingual nitrates, beta-blockade and adenosine
- Structural cardiomyopathy outside of suspected or know ischemic heart disease
Plan de estudios
Esta sección proporciona detalles del plan de estudio, incluido cómo está diseñado el estudio y qué mide el estudio.
¿Cómo está diseñado el estudio?
Detalles de diseño
- Propósito principal: Investigación de servicios de salud
- Asignación: Aleatorizado
- Modelo Intervencionista: Asignación paralela
- Enmascaramiento: Ninguno (etiqueta abierta)
Armas e Intervenciones
Grupo de participantes/brazo |
Intervención / Tratamiento |
|---|---|
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Experimental: CCTA Strategy
CCTA will be performed with one of the latest generation scanners.
A stenosis > 50% will be considered as significant from an anatomical point of view.
For coronary stents, degree of intrastent restenosis will be evaluated by visual assessment of intraluminal contrast density.
ISR > 50% will be considered as significant from an anatomical point of view.
For CABG, each graft will be visually evaluated and scored as patent, non-significant stenosis ≤ 50%, significant stenosis > 50%, or occluded.
For patients with positive CCTA results, additional stress CTP will be performed subsequently.
If indicated, vasodilatation will be induced with i.v.
adenosine injection or regadenoson.
Static or dynamic CTP will be performed according to local practice and scanner technology available.
For all patients with previous history of MI the presence of reversible ischemia will be obtained by the comparison between rest and stress perfusion.
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When judged indicated, functional assessment with stress CTP perfusion will be performed on top of CCTA.
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Comparador activo: Standard of care Strategy
Patients randomized to this group will be evaluated according to current clinical guidelines with the following approaches: (a) stress ECG, or imaging-based tests such as Stress Echo, Stress CMR, SPECT or PET; (b) direct referral to ICA.
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(a) functional non-invasive tests (stress ECG, or imaging-based tests such as Stress Echo, Stress CMR, SPECT or PET) as a gatekeeper for ICA; (b) direct referral to ICA.
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¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
|
Reclassification rate of CCTA in group B due to the addition of CTP
Periodo de tiempo: 30 days.
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For each enrolled patient in whom both CCTA and stress CTP will be performed, the endpoint review committee will use data from coronary CTA and CTP, along with the clinical data to determine the management plan using the following criteria: (a) optimal medical therapy, (b) more non-invasive information required, (c) invasive evaluation required, (d) revascularization treatment (PCI or CABG or hybrid treatment).
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30 days.
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Medidas de resultado secundarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
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Downstream non-invasive testing
Periodo de tiempo: 1- and 2-years.
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Comparison between group A and group B in terms of number of non-invasive downstream testing (Exercise EKG, Stress-Echo, SPECT, Stress CMR, PET) or invasive testing (invasive coronary angiography) performed after the randomization.
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1- and 2-years.
|
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Downstream invasive testing
Periodo de tiempo: 1- and 2-years.
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Comparison between group A and group B in terms of number of downstream invasive testing (invasive coronary angiography) performed after the randomization.
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1- and 2-years.
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Prevalence of obstructive CAD at ICA
Periodo de tiempo: 1- and 2-years.
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Comparison between group A and group B in terms of number of patients with obstructive CAD at ICA.
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1- and 2-years.
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Revascularization
Periodo de tiempo: 1- and 2-years.
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Comparison between group A and group B in terms of number of patients treated with revascularization (PCI or CABG or hybrid treatment).
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1- and 2-years.
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Effective Dose
Periodo de tiempo: 1- and 2-years.
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Comparison between group A and group B in terms of cumulative Effective Dose (ED), measured in mSv, due to non-invasive or invasive testing performed after randomization.
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1- and 2-years.
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Overall costs related to downstream diagnostic tests.
Periodo de tiempo: 1- and 2-years.
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Comparison between group A and group B in terms of overall costs of downstream diagnostic tests (sum of costs of all diagnostic tests performed after randomization), expressed in Dollars, according to local reimbursement.
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1- and 2-years.
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Otras medidas de resultado
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
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Hospitalization for cardiac reason
Periodo de tiempo: 1- and 2-years.
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Comparison between group A and group B group in terms of number of patients that needed hospitalization for cardiac reason.
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1- and 2-years.
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Unstable angina
Periodo de tiempo: 1- and 2-years.
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Comparison between group A and group B group in terms of number of patients that needed hospitalization for unstable angina (defined according to 2015 ESC Guidelines for the management of acute coronary syndromes in patients presenting without persistent ST-segment elevation.
Eur Heart J 2016:37,267-315).
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1- and 2-years.
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Non-fatal myocardial infarction
Periodo de tiempo: 1- and 2-years.
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Comparison between group A and group B group in terms of number of patients that experienced non-fatal myocardial infarction (defined according to Fourth universal definition of myocardial infarction, 2018.
Eur Heart J 2019:40,237-269).
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1- and 2-years.
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Cardiac death
Periodo de tiempo: 1- and 2-years.
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Comparison between group A and group B group in terms of number of patients that experienced death because of immediate cardiac cause (e.g., MI, low-output failure, fatal arrhythmia) or vascular cause (e.g., cerebrovascular disease, pulmonary embolism, ruptured aortic aneurysm, dissecting aneurysm, or other vascular cause).
Unwitnessed death and death of unknown cause will be classified as cardiovascular death.
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1- and 2-years.
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MACE (Major adverse cardiovascular events)
Periodo de tiempo: 1- and 2-years.
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MACE will be defined as a combined endpoint of unstable angina, nonfatal MI, and cardiac death.
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1- and 2-years.
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Cost-effectiveness ratio
Periodo de tiempo: 1- and 2-years.
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Cost-effectiveness ratio will be calculated according to the following equation: (Index test cost + downstream diagnostic tests cost) / projected remaining life expectancy.
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1- and 2-years.
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Colaboradores e Investigadores
Aquí es donde encontrará personas y organizaciones involucradas en este estudio.
Patrocinador
Colaboradores
Investigadores
- Investigador principal: U. Joseph Schoepf, MD, Medical University of South Carolina
- Investigador principal: Gianluca Pontone, MD, PhD, Centro Cardiologico Monzino, IRCCS
Publicaciones y enlaces útiles
La persona responsable de ingresar información sobre el estudio proporciona voluntariamente estas publicaciones. Estos pueden ser sobre cualquier cosa relacionada con el estudio.
Publicaciones Generales
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- Task Force Members; Montalescot G, Sechtem U, Achenbach S, Andreotti F, Arden C, Budaj A, Bugiardini R, Crea F, Cuisset T, Di Mario C, Ferreira JR, Gersh BJ, Gitt AK, Hulot JS, Marx N, Opie LH, Pfisterer M, Prescott E, Ruschitzka F, Sabate M, Senior R, Taggart DP, van der Wall EE, Vrints CJ; ESC Committee for Practice Guidelines; Zamorano JL, Achenbach S, Baumgartner H, Bax JJ, Bueno H, Dean V, Deaton C, Erol C, Fagard R, Ferrari R, Hasdai D, Hoes AW, Kirchhof P, Knuuti J, Kolh P, Lancellotti P, Linhart A, Nihoyannopoulos P, Piepoli MF, Ponikowski P, Sirnes PA, Tamargo JL, Tendera M, Torbicki A, Wijns W, Windecker S; Document Reviewers; Knuuti J, Valgimigli M, Bueno H, Claeys MJ, Donner-Banzhoff N, Erol C, Frank H, Funck-Brentano C, Gaemperli O, Gonzalez-Juanatey JR, Hamilos M, Hasdai D, Husted S, James SK, Kervinen K, Kolh P, Kristensen SD, Lancellotti P, Maggioni AP, Piepoli MF, Pries AR, Romeo F, Ryden L, Simoons ML, Sirnes PA, Steg PG, Timmis A, Wijns W, Windecker S, Yildirir A, Zamorano JL. 2013 ESC guidelines on the management of stable coronary artery disease: the Task Force on the management of stable coronary artery disease of the European Society of Cardiology. Eur Heart J. 2013 Oct;34(38):2949-3003. doi: 10.1093/eurheartj/eht296. Epub 2013 Aug 30. No abstract available. Erratum In: Eur Heart J. 2014 Sep 1;35(33):2260-1.
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- Pontone G, Bertella E, Mushtaq S, Loguercio M, Cortinovis S, Baggiano A, Conte E, Annoni A, Formenti A, Beltrama V, Guaricci AI, Andreini D. Coronary artery disease: diagnostic accuracy of CT coronary angiography--a comparison of high and standard spatial resolution scanning. Radiology. 2014 Jun;271(3):688-94. doi: 10.1148/radiol.13130909. Epub 2014 Feb 8.
- Pontone G, Andreini D, Bartorelli AL, Bertella E, Cortinovis S, Mushtaq S, Foti C, Annoni A, Formenti A, Baggiano A, Conte E, Bovis F, Veglia F, Ballerini G, Fiorentini C, Agostoni P, Pepi M. A long-term prognostic value of CT angiography and exercise ECG in patients with suspected CAD. JACC Cardiovasc Imaging. 2013 Jun;6(6):641-50. doi: 10.1016/j.jcmg.2013.01.015.
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- Mudrick D, Kaltenbach LA, Shah B, Lytle B, Masoudi FA, Mark DB, Federspiel JJ, Cowper PA, Green C, Douglas PS. Downstream testing and subsequent procedures after coronary computed tomographic angiography following coronary stenting in patients >/=65 years of age. Am J Cardiol. 2012 Sep 15;110(6):776-83. doi: 10.1016/j.amjcard.2012.05.004. Epub 2012 May 30.
- Thygesen K, Alpert JS, Jaffe AS, Chaitman BR, Bax JJ, Morrow DA, White HD; ESC Scientific Document Group. Fourth universal definition of myocardial infarction (2018). Eur Heart J. 2019 Jan 14;40(3):237-269. doi: 10.1093/eurheartj/ehy462. No abstract available.
Fechas de registro del estudio
Estas fechas rastrean el progreso del registro del estudio y los envíos de resultados resumidos a ClinicalTrials.gov. Los registros del estudio y los resultados informados son revisados por la Biblioteca Nacional de Medicina (NLM) para asegurarse de que cumplan con los estándares de control de calidad específicos antes de publicarlos en el sitio web público.
Fechas importantes del estudio
Inicio del estudio (Anticipado)
1 de junio de 2019
Finalización primaria (Anticipado)
1 de junio de 2022
Finalización del estudio (Anticipado)
1 de octubre de 2022
Fechas de registro del estudio
Enviado por primera vez
30 de mayo de 2019
Primero enviado que cumplió con los criterios de control de calidad
4 de junio de 2019
Publicado por primera vez (Actual)
6 de junio de 2019
Actualizaciones de registros de estudio
Última actualización publicada (Actual)
6 de junio de 2019
Última actualización enviada que cumplió con los criterios de control de calidad
4 de junio de 2019
Última verificación
1 de junio de 2019
Más información
Términos relacionados con este estudio
Términos MeSH relevantes adicionales
Otros números de identificación del estudio
- R993/19-CCM 1044
Información sobre medicamentos y dispositivos, documentos del estudio
Estudia un producto farmacéutico regulado por la FDA de EE. UU.
No
Estudia un producto de dispositivo regulado por la FDA de EE. UU.
No
Esta información se obtuvo directamente del sitio web clinicaltrials.gov sin cambios. Si tiene alguna solicitud para cambiar, eliminar o actualizar los detalles de su estudio, comuníquese con register@clinicaltrials.gov. Tan pronto como se implemente un cambio en clinicaltrials.gov, también se actualizará automáticamente en nuestro sitio web. .