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Comparison Between FFR Guided Revascularization Versus Conventional Strategy in Acute STEMI Patients With MVD. (CompareAcute)

31 de julio de 2020 actualizado por: Maasstad Hospital

Fractional Flow Reserve Guided Primary Multivessel Percutaneous Coronary Intervention to Improve Guideline Indexed Actual Standard of Care for Treatment of ST-elevation Myocardial Infarction in Patients With Multivessel Coronary Disease

The Compare-Acute trial is a prospective randomised trial in patients with multivessel disease, who are admitted into hospital with a ST-elevation Myocardial Infarction. The purpose of the study is to compare a FFR guided multivessel PCI taking place during the primary PCI with a primary PCI of the culprit vessel only.

Patients will be enrolled after successful revascularisation of the culprit vessel. Patients that have at least one lesion with a diameter of stenosis of more than 50% on visual estimation, feasible (operators judgement) for treatment with PCI in a non-infarct related artery, will be randomised either to the FFR guided complete revascularisation arm or staged revascularisation by proven ischemia or persistence of symptoms of angina.

Approximately 885 patients will be entered in the study.

Study hypothesis: FFR-guided complete percutaneous revascularisation of all flow-limiting stenoses in the non-IRA performed within the same procedure as the primary PCI or within the same hospitalisation will improve clinical outcomes compared to the staged revascularisation, guided by prove of ischemia or clinical judgment, as recommended from the guidelines.

Descripción general del estudio

Estado

Terminado

Condiciones

Intervención / Tratamiento

Descripción detallada

Background of the study: At the moment the general opinion is divided over the way the non culprit lesions in patients presenting with STEMI should be treated. While the previous guidelines stead that these lesions should be treated in a second time ( ie not during the primary intervention) the actual guidelines do not touch this argument. The reason is that the studies where the previous guidelines were based are old. Meanwhile small sized randomised trials from EU region have proven favourable outcomes with NON infarct related artery during the primary procedure while registers (non randomised trials) from USA still recommend the staged treatment. For this reason we have decided to perform a randomised study to address this issue incorporating the state of the art diagnosis and treatment, as well as the new medical therapy and PCI techniques.

Objective of the study: FFR-guided complete percutaneous revascularisation of all flow-limiting stenoses in the non-IRA performed within the same procedure as the primary PCI or within the same hospitalisation will improve clinical outcomes compared to the staged revascularisation, guided by prove of ischemia or clinical judgment, as recommended from the guidelines

Study design: Prospective, 1: 2 randomisation. FFR guided revascularisation during primary PCI (1) versus following actual guidelines (2)

Study population: All STEMI patients between 18-85 years who will be treated with primary PCI in < 12 h (more than 12 hr if persisting pain allowed) after the onset of symptoms and have at least one stenosis of >50% in a non-IRA judged feasible for treatment with PCI.

Intervention (if applicable): FFR-guided complete percutaneous revascularisation of all flow-limiting stenoses in the non-IRA performed within the same procedure as the primary PCI or within the same hospitalisation will improve clinical outcomes compared to the staged revascularisation, guided by prove of ischemia or clinical judgment, as recommended from the guidelines

Primary study parameters/outcome of the study: Composite endpoint of all cause mortality non-fatal Myocardial Infarction, any Revascularisation and Stroke (MACCE) at 12 months

Tipo de estudio

Intervencionista

Inscripción (Actual)

885

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.

Ubicaciones de estudio

  • Alemania
      • Bad Krozingen, Alemania, 79189
        • Herz-Zentrum Bad Krozingen
      • Bad Segeberg, Alemania, 23795
        • Herzzentrum Bad Segeberger Klinik
      • Bremen, Alemania, 28277
        • Klinikum Links der Weser
      • Ingolstadt, Alemania, 85049
        • Medizinische Klinik IV
      • Rostock, Alemania, 18057
        • Medical University Rostock
  • Chequia
      • Brno, Chequia
        • University Hospital Brno
      • Hradec Králové, Chequia
        • University Hospital Hradec Kralove
      • Liberec, Chequia
        • Liberec Regional Hospital
  • Hungría
      • Budapest, Hungría
        • Gottsegen György Országos Kardiológiai Intézet
      • Nyíregyháza, Hungría
        • Szabolcs - Szatmár - Bereg County Hospitals and University Teaching Hospital
      • Szeged, Hungría
        • Szent-Györgyi Albert Klinika
      • Zalaegerszeg, Hungría
        • Zala Megyei Kórház
  • Noruega
      • Oslo, Noruega
        • Oslo University Hospital
  • Países Bajos
      • Arnhem, Países Bajos
        • Rijnstate Hospital
      • Groningen, Países Bajos
        • University Medical Center Groningen
      • Heerlen, Países Bajos
        • Atrium MC Parkstad
      • Maastricht, Países Bajos
        • Maastricht Universitair Medical center
      • Rotterdam, Países Bajos, 3079DZ
        • Maasstadhospital
      • The Hague, Países Bajos, 2512 VA
        • Medisch Centrum Haaglanden
  • Polonia
      • Lubin, Polonia
        • Miedziowe Centrum Zdrowia Lubin
      • Warsaw, Polonia
        • Centralny Szpital Kliniczny MSWiA w Warszawie
      • Warsaw, Polonia
        • Kliniki Kardiologii Allenort
      • Wroclaw, Polonia
        • 4 Wojskowy Szpital Kliniczny z Poliklinika SP ZOZ
  • Singapur
      • Singapore, Singapur, 308433
        • Tan Tock Seng Hospital
      • Singapore, Singapur, 768828
        • Khoo Teck Puat Hospital
  • Suecia
      • Goteborg, Suecia, 41315
        • Sahlgrenska Götheborg University Hospital

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 a 85 años (Adulto, Adulto Mayor)

Acepta Voluntarios Saludables

No

Géneros elegibles para el estudio

Todos

Descripción

Inclusion Criteria:

  • All patients between 18-85 years presenting with STEMI who will be treated with primary PCI in < 12 h after the onset of symptoms* and have at least one stenosis of >50% in a non-IRA on QCA or visual estimation of baseline angiography and judged feasible for treatment with PCI by the operator.

    • Patients with symptoms for more than 12 hr but ongoing angina complaints can be randomised

Exclusion Criteria:

  1. Left main stem disease (stenosis > 50%)
  2. STEMI due to in-stent thrombosis
  3. Chronic total occlusion of a non-IRA
  4. Severe stenosis with TIMI flow ≤ II of the non-IRA artery.
  5. Non-IRA stenosis not amenable for PCI treatment (operators decision)

  6. Complicated IRA treatment, with one or more of the following;

    • Extravasation,
    • Permanent no re-flow after IRA treatment (TIMI flow 0-1),
    • Inability to implant a stent
  7. Known severe cardiac valve dysfunction that will require surgery in the follow-up period.
  8. Killip class III or IV already at presentation or at the completion of culprit lesion treatment.
  9. Life expectancy of < 2 years.
  10. Intolerance to Aspirin, Clopidogrel, Prasugrel, Ticagrelor, Heparin, Bivaluridin, or Everolimus and known true anaphylaxis to prior contrast media of bleeding diathesis or known coagulopathy.
  11. Gastrointestinal or genitourinary bleeding within the prior 3 months,
  12. Planned elective surgical procedure necessitating interruption of thienopyridines during the first 6 months post enrolment.
  13. Patients who are actively participating in another drug or device investigational study, which have not completed the primary endpoint follow-up period.
  14. Pregnancy or planning to become pregnant any time after enrolment into this study.
  15. Inability to obtain informed consent.
  16. Expected lost to follow-up.

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: Tratamiento
  • Asignación: Aleatorizado
  • Modelo Intervencionista: Asignación paralela
  • Enmascaramiento: Ninguno (etiqueta abierta)

Armas e Intervenciones

Grupo de participantes/brazo
Intervención / Tratamiento
Comparador activo: FFR-guided revascularisation strategy
In the FFR-group all flow limiting (FFR≤0.80) lesions will receive treatment by PCI and stenting. The non-IRA PCI should be performed during the same intervention. Exceptions can be made for complex lesions where the operator estimates that the revascularisation procedure will require significant contrast overload which may lead to deterioration of cardiac and renal function of the patient. Such procedures can be performed in a second procedure which should take place within the same hospitalisation. All lesions with a FFR measurement of >0.80 will not be treated.
Procedimiento: FFR-guided revascularisation strategy
FFR-guided revascularisation strategy
Comparador de placebos: randomised to guidelines group
In the randomised to guidelines group the procedure will stop after the FFR measurements and the patient will be referred to his treating cardiologist who will decide whether a staged PCI of the non-IRA artery should take place. The treating cardiologist will be blinded for the FFR measurements (but not angiographic imaging) and must make a decision based on conventional non-invasive ischemia detecting tests or clinical signs and symptoms i.e. very typical angina symptoms in patients with angiographic significant stenosis).
Procedimiento: randomised to guidelines group
Staged revascularisation by proven ischemia or persistence of symptoms of angina

¿Qué mide el estudio?

Medidas de resultado primarias

Medida de resultado
Medida Descripción
Periodo de tiempo
Number of Participants With the Composite Endpoint of MACCE
Periodo de tiempo: 12 months
Number of participants with the composite endpoint of all cause mortality non-fatal Myocardial Infarction, any Revascularisation and Cerebrovascular Events (MACCE) at 12 months between groups
12 months
Number of Participants With Death From Any Cause
Periodo de tiempo: 12 months
Number of participants with all cause mortality at 12 months between groups
12 months
Number of Participants With Cardiac Death
Periodo de tiempo: 12 months
Number of participants with Cardiac mortality at 12 months between groups
12 months
Number of Participants With Spontaneous MI
Periodo de tiempo: 12 months
Number of participants with Spontaneous Myocardial Infarction at 12 months between groups
12 months
Number of Participants With Periprocedural MI
Periodo de tiempo: 12 months
Number of participants with Periprocedural Myocardial Infarction at 12 months between groups
12 months
Number of Participants With Revascularization - PCI
Periodo de tiempo: 12 months
Number of participants with revascularization PCI at 12 months between groups
12 months
Number of Participants With Revascularization - CABG
Periodo de tiempo: 12 months
Number of participants with revascularization CABG at 12 months between groups
12 months
Number of Participants With Cerebrovascular Event
Periodo de tiempo: 12 months
Number of participants with Cerebrovascular event at 12 months between groups
12 months

Medidas de resultado secundarias

Medida de resultado
Medida Descripción
Periodo de tiempo
Number of Participants With Composite Endpoint of NACE (Any First Event)
Periodo de tiempo: 12 months
Number of participants with Composite endpoint of Cardiac death, Myocardial Infarction, any Revascularisation, Stroke and Major bleeding at 12 months (NACE i.e. Net Adverse Clinical Events)
12 months
Number of Participants With Death From Any Cause or MI
Periodo de tiempo: 12 months
Number of participants with Part of composite NACE-Death from any cause or Myocardial Infarction at 12 months
12 months
Number of Participants With Major Bleeding
Periodo de tiempo: 12 months
Number of participants with Major bleeding at 12 months - Part of composite NACE
12 months
Number of Participants With Any Bleeding at 12 Months
Periodo de tiempo: 12 months
Number of participants with any bleeding at 12 months - part of composite endpoint NACE
12 months
Number of Participants With Any Bleeding at 48 Hours
Periodo de tiempo: 48 hours
Number of participants with any bleeding at 48 hours - part of composite endpoint NACE
48 hours
Number of Participants With Hospitalization
Periodo de tiempo: 12 months
Number of participants with hospitalization for heart failure, unstable angina or chest pain
12 months
Number of Participants With Revascularization
Periodo de tiempo: 12 months
Number of participants with any revascularization-Part of composite endpoint NACE
12 months
Number of Participants With Stent Thrombosis
Periodo de tiempo: 12 months
Number of participants with Stent Thrombosis - Part of composite endpoint NACE
12 months
Number of Participants With Primary Endpoint Outcome MACCE (Any First Event) at 3 Year
Periodo de tiempo: 3 year
Number of participants with Composite primary endpoint MACCE (any first event) at 3 year
3 year
Number of Participants With All Cause Death at 3 Year
Periodo de tiempo: 3 year
Number of participants with Composite endpoint MACCE (any first event) at 3 year - all cause death
3 year
Number of Participants With Cardiac Death at 3 Year
Periodo de tiempo: 3 year
Number of participants with Composite endpoint MACCE (any first event) at 3 year - Cardiac death
3 year
Number of Participants With Spontaneous MI at 3 Year
Periodo de tiempo: 3 year
Number of participants with Composite endpoint MACCE (any first event) at 3 year - Spontaneous MI
3 year
Number of Participants With Peri-procedural MI at 3 Year
Periodo de tiempo: 3 year
Number of participants with Composite endpoint MACCE (any first event) at 3 year - Peri-procedural MI
3 year
Number of Participants With Urgent Revascularization at 3 Year
Periodo de tiempo: 3 year
Number of participants with Composite endpoint MACCE (any first event) at 3 year - urgent revascularisation
3 year
Number of Participants With Elective Revascularization at 3 Year
Periodo de tiempo: 3 year
Number of participants with Composite endpoint MACCE (any first event) at 3 year -elective revascularisation
3 year
Number of Participants With Cerebrovascular Event
Periodo de tiempo: 3 year
Number of participants with Composite endpoint MACCE (any first event) at 3 year -Cerebrovascular event
3 year
Number of Participants With Composite Endpoint of NACE (Any First Event) at 3 Year
Periodo de tiempo: 3 years
Number of participants with Composite endpoint of Cardiac death, Myocardial Infarction, any Revascularisation, Stroke and Major bleeding at 3 year (NACE i.e. Net Adverse Clinical Events)
3 years
Number of Participants With Death From Any Cause or MI
Periodo de tiempo: 3 year
Number of participants with Part of composite NACE-Death from any cause or Myocardial Infarction at 3 year
3 year
Number of Participants With Major Bleeding at 3 Year
Periodo de tiempo: 3 year
Number of participants with Part of composite endpoint NACE- Major bleeding at 3 year
3 year
Number of Participants With Hospitalization
Periodo de tiempo: 3 year
Number of participants with Hospitalization for heart failure, unstable angina, MI
3 year
Number of Participants With Hospitalization at 3 Year
Periodo de tiempo: 3 year
Number of participants with Hospitalization for heart failure, unstable angina, MI and/or chest pain
3 year
Number of Participants With Stent Thrombosis at 3 Year
Periodo de tiempo: 3 year
Number of participants with Stent Thrombosis at 3 year - Part of composite endpoint NACE
3 year
Number of Participants With Any Bleeding at 3 Year
Periodo de tiempo: 3 year
Number of participants with any bleeding at 3 year - Part of composite endpoint NACE
3 year

Otras medidas de resultado

Medida de resultado
Medida Descripción
Periodo de tiempo
A Comparison of the Number of Patients in Both Groups With Treated Lesions With FFR ≤ 0.80 Versus Patients With Untreated Lesions With FFR ≤ 0.80;
Periodo de tiempo: 3 year
FFR+/PCI+ vs FFR+/PCI- Comparison of patients having FFR positive lesions that underwent revascularization during index procedure or in staged procedures within 45 days (groups A+C, n=202 patients) with patients having FFR positive lesions that did not undergo revascularization (group D, n=231 patients),
3 year
Comparison of Acute Versus Staged PCI for Lesions With FFR ≤ 0.80
Periodo de tiempo: 3 year
Comparison of acute versus staged PCI treatment for lesions with FFR
3 year
Comparison of PCI vs Medical Therapy in FFR Negative Lesions
Periodo de tiempo: 3 year
comparison of patients receiving staged PCI treatment of FFR-negative lesions in the non-IRA (decision made by referring physician who was blinded to FFR results) and patients receiving medical therapy for FFR-negative lesions in the non-IRA
3 year

Colaboradores e Investigadores

Aquí es donde encontrará personas y organizaciones involucradas en este estudio.

Patrocinador

Maasstad Hospital

Colaboradores

Abbott Medical Devices

Investigadores

  • Investigador principal: Peter Smits, MD. PHD, Maastadhospital / MCR
  • Silla de estudio: Elmir Omerovic, MD PhD, Sahlgrenska Hospital Götheborg
  • Silla de estudio: Gert Richardt, MD PhD, Herzzentrum Segeberger Kliniken
  • Silla de estudio: Franz-Josef Neumann, MD PhD, Herz-Zentrum Bad Krozingen

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

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

1 de julio de 2011

Finalización primaria (Actual)

31 de octubre de 2016

Finalización del estudio (Actual)

31 de octubre de 2018

Fechas de registro del estudio

Enviado por primera vez

20 de julio de 2011

Primero enviado que cumplió con los criterios de control de calidad

21 de julio de 2011

Publicado por primera vez (Estimar)

22 de julio de 2011

Actualizaciones de registros de estudio

Última actualización publicada (Actual)

11 de agosto de 2020

Última actualización enviada que cumplió con los criterios de control de calidad

31 de julio de 2020

Última verificación

1 de mayo de 2020

Más información

Términos relacionados con este estudio

Palabras clave

Términos MeSH relevantes adicionales

Otros números de identificación del estudio

  • Compare-Acute

Plan de datos de participantes individuales (IPD)

¿Planea compartir datos de participantes individuales (IPD)?

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. .

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