Thrombus Aspiration in ThrOmbus Containing culpRiT Lesions in Non-ST-Elevation Myocardial Infarction (TATORT-NSTEMI)
1 de mayo de 2017 actualizado por: Holger Thiele, University of Leipzig
Whereas thrombus aspiration in patients with ST-elevation myocardial infarction (STEMI) is recommended by current guidelines, there are insufficient data to unequivocally support thrombectomy in patients with non-STEMI (NSTEMI).
The Thrombus Aspiration in ThrOmbus containing culpRiT lesions in Non-ST-Elevation Myocardial Infarction (TATORT-NSTEMI) trial is a 400 patient, prospective, controlled, multicenter, randomized, open-label trial.
The hypothesis is that under the background of early revascularization, adjunctive thrombectomy in comparison to conventional percutaneous coronary intervention (PCI) alone leads to less microvascular obstruction (MO) assessed by cardiac magnetic resonance imaging (CMR) in patients with NSTEMI.
Patients will be randomized in a 1:1 fashion to one of the two treatment arms.
The primary endpoint is the extent of MO assessed by CMR.
Secondary endpoints include infarct size and myocardial salvage assessed by CMR, enzymatic infarct size as well as angiographic parameters, such as Thrombolysis in Myocardial Infarction-flow post-PCI and myocardial blush grade.
Furthermore, clinical endpoints including death, myocardial reinfarction, target vessel revascularization and new congestive heart failure will be recorded at 6 and 12 months.
Safety will be assessed by bleeding and stroke.
In summary, the TATORT-NSTEMI trial has been designed to test the hypothesis that thrombectomy will improve myocardial perfusion in patients with NSTEMI and relevant thrombus burden in the culprit vessel reperfused by early PCI.
Descripción general del estudio
Estado
Terminado
Intervención / Tratamiento
Tipo de estudio
Intervencionista
Inscripción (Anticipado)
400
Fase
- Fase 4
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
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Bad Berka, Alemania
- Zentralklinik Bad Berka
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Berlin, Alemania
- Unfallkrankenhaus Berlin
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Frankfurt/Oder, Alemania
- Klinikum Frankfurt/Oder
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Homburg, Alemania
- University of Saarland, Campus Homburg/Saar
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Leipzig, Alemania
- University of Leipzig
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Ludwigshafen, Alemania
- Institut für Herzinfarktforschung
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Tübingen, Alemania
- University of Tubingen
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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 90 años (Adulto, Adulto Mayor)
Acepta Voluntarios Saludables
No
Géneros elegibles para el estudio
Todos
Descripción
Inclusion Criteria:
- ischemic symptoms such as angina pectoris >20 minutes
- occurrence of last symptoms <72 h before randomization
- cardiac troponin T or I levels above the 99th percentile
- culprit lesion containing thrombus (TIMI-thrombus grade 2-5 within the lesion) and intended early PCI
Exclusion Criteria:
- cardiogenic shock
- STEMI
- no identifiable culprit lesion or a TIMI-thrombus grade <2
- coronary morphology ineligible for thrombectomy (e.g. very tortuous vessels, severe calcification)
- indication for acute bypass surgery
- age <18 and >90 years
- contraindications for treatment with heparin, aspirin or thienopyridines
- pregnancy
- current participation in another clinical study
- co-morbidity with limited life expectancy <6 months
- contraindications to CMR at study entry
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: Único
Armas e Intervenciones
Grupo de participantes/brazo |
Intervención / Tratamiento |
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Comparador activo: Trombectomía
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Manual thrombectomy will be performed in the thrombus aspiration group using an aspiration catheter utilized in daily clinical routine (Eliminate, Terumo Europe, Leuven, Belgium).
In the standard PCI group, patients will be treated by conventional PCI according to local practice without thrombectomy.
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Otro: Standard percutaneous coronary intervention
In the standard percutaneous coronary intervention (PCI) group, patients will be treated by conventional PCI according to local practice without thrombectomy.
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In the standard percutaneous coronary intervention (PCI) group, patients will be treated by conventional PCI according to local practice without thrombectomy.
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¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Periodo de tiempo |
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Extent of late microvascular obstruction assessed by cardiac magnetic resonance imaging (CMR)
Periodo de tiempo: CMR performed within day 1 to 4 after randomization
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CMR performed within day 1 to 4 after randomization
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Medidas de resultado secundarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
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Infarct size assessed by cardiac magnetic resonance imaging (CMR)
Periodo de tiempo: CMR performed within day 1 to 4 after randomization
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CMR performed within day 1 to 4 after randomization
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Myocardial salvage assessed by cardiac magnetic resonance imaging (CMR)
Periodo de tiempo: CMR performed within day 1 to 4 after randomization
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CMR performed within day 1 to 4 after randomization
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Left ventricular ejection fraction assessed by cardiac magnetic resonance imaging (CMR)
Periodo de tiempo: CMR performed within day 1 to 4 after randomization
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CMR performed within day 1 to 4 after randomization
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Thrombolysis in Myocardial Infarction (TIMI)-flow post-PCI
Periodo de tiempo: Immediately after percutaneous coronary intervention
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Immediately after percutaneous coronary intervention
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Myocardial blush grade
Periodo de tiempo: Immediately after percutaneous coronary intervention
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Immediately after percutaneous coronary intervention
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Troponin T
Periodo de tiempo: 24 and 48 hours after randomization
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24 and 48 hours after randomization
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Combined clinical endpoint
Periodo de tiempo: Follow-up performed at 6, 12 and approximately 60 months after randomization
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Occurence of a combined clinical endpoint including death, re-infarction, target vessel revascularization and congestive heart failure will be recorded.
Clinical outcome will be assessed by a telephone interview at 6 and 12 months.
Any clinical event will be verified by hospital or general practitioner records.
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Follow-up performed at 6, 12 and approximately 60 months after randomization
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Assessment of quality of life
Periodo de tiempo: 6, 12 and approximately 60 months after randomization
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6, 12 and approximately 60 months after randomization
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Stroke and bleeding
Periodo de tiempo: Participants will be followed for the duration of hospital stay (an expected average of 5 days)
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Participants will be followed for the duration of hospital stay (an expected average of 5 days)
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Colaboradores e Investigadores
Aquí es donde encontrará personas y organizaciones involucradas en este estudio.
Patrocinador
Investigadores
- Investigador principal: Holger Thiele, MD, Heart Center Leipzig, University of Leipzig, Germany
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
- Backhaus SJ, Rosel SF, Stiermaier T, Schmidt-Rimpler J, Evertz R, Schulz A, Lange T, Kowallick JT, Kutty S, Bigalke B, Gutberlet M, Hasenfuss G, Thiele H, Eitel I, Schuster A. Left-atrial long-axis shortening allows effective quantification of atrial function and optimized risk prediction following acute myocardial infarction. Eur Heart J Open. 2022 Aug 12;2(5):oeac053. doi: 10.1093/ehjopen/oeac053. eCollection 2022 Sep.
- Backhaus SJ, Aldehayat H, Kowallick JT, Evertz R, Lange T, Kutty S, Bigalke B, Gutberlet M, Hasenfuss G, Thiele H, Stiermaier T, Eitel I, Schuster A. Artificial intelligence fully automated myocardial strain quantification for risk stratification following acute myocardial infarction. Sci Rep. 2022 Jul 18;12(1):12220. doi: 10.1038/s41598-022-16228-w.
- Lange T, Stiermaier T, Backhaus SJ, Boom PC, Kowallick JT, de Waha-Thiele S, Lotz J, Kutty S, Bigalke B, Gutberlet M, Feistritzer HJ, Desch S, Hasenfuss G, Thiele H, Eitel I, Schuster A. Functional and prognostic implications of cardiac magnetic resonance feature tracking-derived remote myocardial strain analyses in patients following acute myocardial infarction. Clin Res Cardiol. 2021 Feb;110(2):270-280. doi: 10.1007/s00392-020-01747-1. Epub 2020 Oct 20.
- Schuster A, Lange T, Backhaus SJ, Strohmeyer C, Boom PC, Matz J, Kowallick JT, Lotz J, Steinmetz M, Kutty S, Bigalke B, Gutberlet M, de Waha-Thiele S, Desch S, Hasenfuss G, Thiele H, Stiermaier T, Eitel I. Fully Automated Cardiac Assessment for Diagnostic and Prognostic Stratification Following Myocardial Infarction. J Am Heart Assoc. 2020 Sep 15;9(18):e016612. doi: 10.1161/JAHA.120.016612. Epub 2020 Sep 2.
- Backhaus SJ, Kowallick JT, Stiermaier T, Lange T, Navarra JL, Koschalka A, Evertz R, Lotz J, Kutty S, Hasenfuss G, Gutberlet M, Thiele H, Eitel I, Schuster A. Cardiac Magnetic Resonance Myocardial Feature Tracking for Optimized Risk Assessment After Acute Myocardial Infarction in Patients With Type 2 Diabetes. Diabetes. 2020 Jul;69(7):1540-1548. doi: 10.2337/db20-0001. Epub 2020 Apr 24.
- Schuster A, Backhaus SJ, Stiermaier T, Kowallick JT, Stulle A, Koschalka A, Lotz J, Kutty S, Bigalke B, Gutberlet M, Hasenfuss G, Thiele H, Eitel I. Fast manual long-axis strain assessment provides optimized cardiovascular event prediction following myocardial infarction. Eur Heart J Cardiovasc Imaging. 2019 Nov 1;20(11):1262-1270. doi: 10.1093/ehjci/jez077.
- Backhaus SJ, Kowallick JT, Stiermaier T, Lange T, Koschalka A, Navarra JL, Lotz J, Kutty S, Bigalke B, Gutberlet M, Feistritzer HJ, Hasenfuss G, Thiele H, Schuster A, Eitel I. Culprit vessel-related myocardial mechanics and prognostic implications following acute myocardial infarction. Clin Res Cardiol. 2020 Mar;109(3):339-349. doi: 10.1007/s00392-019-01514-x. Epub 2019 Jul 5.
- Feistritzer HJ, Meyer-Saraei R, Lober C, Bohm M, Scheller B, Lauer B, Geisler T, Gawaz M, Bruch L, Klein N, Zeymer U, Eitel I, Jobs A, Freund A, Desch S, de Waha-Thiele S, Thiele H. Long-term outcome after thrombus aspiration in non-ST-elevation myocardial infarction: results from the TATORT-NSTEMI trial : Thrombus aspiration in acute myocardial infarction. Clin Res Cardiol. 2020 Oct;109(10):1223-1231. doi: 10.1007/s00392-020-01613-0. Epub 2020 Feb 6.
- Thiele H, de Waha S, Zeymer U, Desch S, Scheller B, Lauer B, Geisler T, Gawaz M, Gunkel O, Bruch L, Klein N, Pfeiffer D, Schuler G, Eitel I. Effect of aspiration thrombectomy on microvascular obstruction in NSTEMI patients: the TATORT-NSTEMI trial. J Am Coll Cardiol. 2014 Sep 16;64(11):1117-24. doi: 10.1016/j.jacc.2014.05.064.
- de Waha S, Eitel I, Desch S, Scheller B, Bohm M, Lauer B, Gawaz M, Geisler T, Gunkel O, Bruch L, Klein N, Pfeiffer D, Schuler G, Zeymer U, Thiele H. Thrombus Aspiration in ThrOmbus containing culpRiT lesions in Non-ST-Elevation Myocardial Infarction (TATORT-NSTEMI): study protocol for a randomized controlled trial. Trials. 2013 Apr 25;14:110. doi: 10.1186/1745-6215-14-110.
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 marzo de 2011
Finalización primaria (Actual)
1 de junio de 2013
Finalización del estudio (Actual)
1 de octubre de 2016
Fechas de registro del estudio
Enviado por primera vez
30 de mayo de 2012
Primero enviado que cumplió con los criterios de control de calidad
1 de junio de 2012
Publicado por primera vez (Estimar)
5 de junio de 2012
Actualizaciones de registros de estudio
Última actualización publicada (Actual)
2 de mayo de 2017
Última actualización enviada que cumplió con los criterios de control de calidad
1 de mayo de 2017
Última verificación
1 de mayo de 2017
Más información
Términos relacionados con este estudio
Palabras clave
Términos MeSH relevantes adicionales
Otros números de identificación del estudio
- 070-11-07032011
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. .