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- Registro de ensayos clínicos de EE. UU.
- Ensayo clínico NCT00279175
REPAIR-AMI: Intracoronary Progenitor Cells in Acute Myocardial Infarction (AMI)
Reinfusion of Enriched Progenitor Cells And Infarct Remodeling in Acute Myocardial Infarction (REPAIR - AMI)
Impaired contractile function after a heart attack of the heart is a major cause of "heart failure" limiting quality of life and prognosis, which cannot be prevented even with optimal standard therapy, including immediate balloon/stent dilation of the infarct vessel.
The aim of the REPAIR-AMI trial is to investigate whether infusion of progenitor cells into the infarct vessel (after successful reperfusion therapy) may improve left ventricular contractile function compared to placebo therapy. After bone marrow aspiration progenitor cells are enriched via a centrifugation method.
Descripción general del estudio
Estado
Condiciones
Descripción detallada
- The study is a double-blind, placebo-controlled, randomized, multicenter trial.
- Patients after an acute myocardial infarction, undergoing successful reperfusion therapy are included.
- All patients undergo bone marrow aspiration 3 to 6 days after the infarction.
- After cell processing, enriched bone marrow-derived progenitor cells or placebo medium is infused direct into the infarct related artery during stop-flow. In addition, a left ventricular angiography is performed.
- After 4 months left ventricular angiography is repeated. The primary endpoint is the difference in change of left ventricular ejection fraction between the two groups.
Tipo de estudio
Inscripción (Actual)
Fase
- Fase 3
Contactos y Ubicaciones
Ubicaciones de estudio
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Bad Berka, Alemania, 99437
- Zentralklinik Bad Berka
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Bad Nauheim, Alemania, 61231
- Kerckhoff Klinik
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Bad Oeynhausen, Alemania, 32545
- Herz- und Diabeteszentrum NRW
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Bochum, Alemania, 44789
- BG Kliniken Bergmannsheil
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Detmold, Alemania, 32756
- Klinikum Lippe
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Frankfurt, Alemania, 60590
- J. W. Goethe University Hospitals
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Frankfurt, Alemania, 60316
- Rotes-Kreuz Krankenhaus - Kardiologisches Centrum
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Giessen, Alemania, 35392
- Universitätsklinkum Giessen
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Hamburg, Alemania, 22763
- Parxis Schofer, Mathey und Partner
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Homburg/Saar, Alemania, 66421
- Universitätsklikum Homburg
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Kassel, Alemania, 34125
- Klinikum Kassel
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Leipzig, Alemania, 04289
- Herzzentrum - Universität Leipzig
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Ludwigshafen, Alemania, 67073
- Herzzentrum Ludwigshafen
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Mainz, Alemania, 55131
- Universitatsklinik Mainz
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Mannheim, Alemania, 68167
- Universitätsklinikum Mannheim
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Suhl, Alemania, 98527
- Zentralklinikum Suhl
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Zürich, Suiza, 8091
- Universitätsspital Zürich
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Criterios de participación
Criterio de elegibilidad
Edades elegibles para estudiar
Acepta Voluntarios Saludables
Géneros elegibles para el estudio
Descripción
Inclusion Criteria:
Patients with acute myocardial infarction (ST elevation in at least 2 leads >= 0.2 mV in V1,V2 or V3 or >= 0.1 mV in other leads), treated by one of the following procedures
- Either acute PCI with stent implantation within 24 hours after symptom onset or
- treatment with thrombolysis within 12 hours of symptom onset followed by PCI with stent implantation within 24 hours after thrombolysis.
- Acute PCI / stent implantation has been successful (residual stenosis visually < 30% and TIMI flow >= 2).
- At the time of inclusion patient does no longer require i.v. catecholamines or mechanical hemodynamic support (aortic balloon pump)
- Significant regional wall motion abnormality in LV angiogram at the time of acute PCI (ejection fraction <= 45% on visual estimation).
- Maximal CK elevation >= 400 U/l (measured at 37° C) with significant MB fraction > 6%
- Age 18 - 80 Years
- Written informed consent
Exclusion Criteria:
- Regional wall motion abnormality outside the area involved in the index acute myocardial infarction.
- Need to revascularize additional vessels, outside the infarct artery.
- Arteriovenous malformations or aneurysms
- Active infection (CRP > 10 mg/dl) now, or fever or diarrhea within last 4 weeks.
- Chronic inflammatory disease
- HIV infection or active hepatitis
- Neoplastic disease without documented remission within the past 5 years.
- Cerebrovascular insult within 3 months
- Impaired renal function (creatinine > 2 mg/dl) at the time of cell therapy
- Significant liver disease (GOT > 2x upper limit) or spontaneous INR > 1,5)
- Anemia (hemoglobin < 8.5 mg/dl)
- Platelet count < 100.000/µl
- Hypersplenism
- Known allergy or intolerance to clopidogrel, heparin or abciximab.
- History of bleeding disorder
- Gastrointestinal bleeding within 3 months
- Major surgical procedure or traumata within 2 months
- Uncontrolled hypertension
- Pregnancy
- Mental retardation
- Previously performed stem / progenitor cell therapy
- Participation in another clinical trial within the last 30 days.
Plan de estudios
¿Cómo está diseñado el estudio?
Detalles de diseño
- Propósito principal: Tratamiento
- Asignación: Aleatorizado
- Modelo Intervencionista: Asignación paralela
- Enmascaramiento: Cuadruplicar
Armas e Intervenciones
Grupo de participantes/brazo |
Intervención / Tratamiento |
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Experimental: BMC
Intracoronary infusion of autologous bone marrow derived cells
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Comparador de placebos: Placebo
Intracoronary infusion of Placebo medium
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¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
---|---|---|
Change in global left ventricular function in quantitative LV angiography after 4 months.
Periodo de tiempo: baseline to 4 months
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absolute delta LVEF (%)
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baseline to 4 months
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Medidas de resultado secundarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
---|---|---|
Primary endpoint in patients without restenosis.
Periodo de tiempo: baseline to 4 months
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absolute delta LVEF (%)
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baseline to 4 months
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Improvement of regional wall motion in infarct area
Periodo de tiempo: baseline to 4 months
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baseline to 4 months
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Reduction of LV end-systolic volume
Periodo de tiempo: baseline to 4 months
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baseline to 4 months
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Major adverse cardiac events (MACE)
Periodo de tiempo: at 4, 12 and 60 months
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at 4, 12 and 60 months
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Rehospitalization due to heart failure.
Periodo de tiempo: 4, 12, 60 months
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4, 12, 60 months
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NYHA status after 12 months
Periodo de tiempo: 12 months
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12 months
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Amendment for extended follow up after 2 and 5 years:
Periodo de tiempo: 24 and 60 months
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24 and 60 months
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outcomes in major adverse cardiac events (MACE)
Periodo de tiempo: 4, 12, 60 months
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4, 12, 60 months
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Rehospitalization due to heart failure
Periodo de tiempo: 4, 12, 60 months
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4, 12, 60 months
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NYHA status
Periodo de tiempo: 4, 12, 60 months
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4, 12, 60 months
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patients in MRI subgroup: improvement in left ventricular function
Periodo de tiempo: 4, 12, 60 months
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4, 12, 60 months
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Colaboradores e Investigadores
Patrocinador
Colaboradores
Investigadores
- Investigador principal: Andreas M Zeiher, MD, J. W. Goethe University Hospitals
- Director de estudio: Volker Schächinger, MD, J. W. Goethe University Hopspitals
Publicaciones y enlaces útiles
Publicaciones Generales
- Schachinger V, Tonn T, Dimmeler S, Zeiher AM. Bone-marrow-derived progenitor cell therapy in need of proof of concept: design of the REPAIR-AMI trial. Nat Clin Pract Cardiovasc Med. 2006 Mar;3 Suppl 1:S23-8. doi: 10.1038/ncpcardio0441.
- Schachinger V, Erbs S, Elsasser A, Haberbosch W, Hambrecht R, Holschermann H, Yu J, Corti R, Mathey DG, Hamm CW, Suselbeck T, Assmus B, Tonn T, Dimmeler S, Zeiher AM; REPAIR-AMI Investigators. Intracoronary bone marrow-derived progenitor cells in acute myocardial infarction. N Engl J Med. 2006 Sep 21;355(12):1210-21. doi: 10.1056/NEJMoa060186.
- Schachinger V, Erbs S, Elsasser A, Haberbosch W, Hambrecht R, Holschermann H, Yu J, Corti R, Mathey DG, Hamm CW, Suselbeck T, Werner N, Haase J, Neuzner J, Germing A, Mark B, Assmus B, Tonn T, Dimmeler S, Zeiher AM; REPAIR-AMI Investigators. Improved clinical outcome after intracoronary administration of bone-marrow-derived progenitor cells in acute myocardial infarction: final 1-year results of the REPAIR-AMI trial. Eur Heart J. 2006 Dec;27(23):2775-83. doi: 10.1093/eurheartj/ehl388. Epub 2006 Nov 10.
- Dill T, Schachinger V, Rolf A, Mollmann S, Thiele H, Tillmanns H, Assmus B, Dimmeler S, Zeiher AM, Hamm C. Intracoronary administration of bone marrow-derived progenitor cells improves left ventricular function in patients at risk for adverse remodeling after acute ST-segment elevation myocardial infarction: results of the Reinfusion of Enriched Progenitor cells And Infarct Remodeling in Acute Myocardial Infarction study (REPAIR-AMI) cardiac magnetic resonance imaging substudy. Am Heart J. 2009 Mar;157(3):541-7. doi: 10.1016/j.ahj.2008.11.011. Epub 2009 Jan 31.
- Erbs S, Linke A, Schachinger V, Assmus B, Thiele H, Diederich KW, Hoffmann C, Dimmeler S, Tonn T, Hambrecht R, Zeiher AM, Schuler G. Restoration of microvascular function in the infarct-related artery by intracoronary transplantation of bone marrow progenitor cells in patients with acute myocardial infarction: the Doppler Substudy of the Reinfusion of Enriched Progenitor Cells and Infarct Remodeling in Acute Myocardial Infarction (REPAIR-AMI) trial. Circulation. 2007 Jul 24;116(4):366-74. doi: 10.1161/CIRCULATIONAHA.106.671545. Epub 2007 Jul 9.
- Assmus B, Rolf A, Erbs S, Elsasser A, Haberbosch W, Hambrecht R, Tillmanns H, Yu J, Corti R, Mathey DG, Hamm CW, Suselbeck T, Tonn T, Dimmeler S, Dill T, Zeiher AM, Schachinger V; REPAIR-AMI Investigators. Clinical outcome 2 years after intracoronary administration of bone marrow-derived progenitor cells in acute myocardial infarction. Circ Heart Fail. 2010 Jan;3(1):89-96. doi: 10.1161/CIRCHEARTFAILURE.108.843243. Epub 2009 Dec 8.
- Rolf A, Assmus B, Schachinger V, Rixe J, Mollmann S, Mollmann H, Dimmeler S, Zeiher AM, Hamm CW, Dill T. Maladaptive hypertrophy after acute myocardial infarction positive effect of bone marrow-derived stem cell therapy on regional remodeling measured by cardiac MRI. Clin Res Cardiol. 2011 Nov;100(11):983-92. doi: 10.1007/s00392-011-0330-3. Epub 2011 Jun 17.
- Assmus B, Tonn T, Seeger FH, Yoon CH, Leistner D, Klotsche J, Schachinger V, Seifried E, Zeiher AM, Dimmeler S. Red blood cell contamination of the final cell product impairs the efficacy of autologous bone marrow mononuclear cell therapy. J Am Coll Cardiol. 2010 Mar 30;55(13):1385-94. doi: 10.1016/j.jacc.2009.10.059.
Fechas de registro del estudio
Fechas importantes del estudio
Inicio del estudio
Finalización primaria (Actual)
Finalización del estudio (Actual)
Fechas de registro del estudio
Enviado por primera vez
Primero enviado que cumplió con los criterios de control de calidad
Publicado por primera vez (Estimar)
Actualizaciones de registros de estudio
Última actualización publicada (Estimar)
Última actualización enviada que cumplió con los criterios de control de calidad
Última verificación
Más información
Términos relacionados con este estudio
Palabras clave
Términos MeSH relevantes adicionales
Otros números de identificación del estudio
- 2/04
- Paul-Ehrlich-Institute 1034/01
- EudraCT 2006-000250-43
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