- ICH GCP
- Registro de ensaios clínicos dos EUA
- Ensaio 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.
Visão geral do estudo
Status
Condições
Descrição detalhada
- 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 estudo
Inscrição (Real)
Estágio
- Fase 3
Contactos e Locais
Locais de estudo
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Bad Berka, Alemanha, 99437
- Zentralklinik Bad Berka
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Bad Nauheim, Alemanha, 61231
- Kerckhoff Klinik
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Bad Oeynhausen, Alemanha, 32545
- Herz- und Diabeteszentrum NRW
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Bochum, Alemanha, 44789
- BG Kliniken Bergmannsheil
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Detmold, Alemanha, 32756
- Klinikum Lippe
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Frankfurt, Alemanha, 60590
- J. W. Goethe University Hospitals
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Frankfurt, Alemanha, 60316
- Rotes-Kreuz Krankenhaus - Kardiologisches Centrum
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Giessen, Alemanha, 35392
- Universitätsklinkum Giessen
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Hamburg, Alemanha, 22763
- Parxis Schofer, Mathey und Partner
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Homburg/Saar, Alemanha, 66421
- Universitätsklikum Homburg
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Kassel, Alemanha, 34125
- Klinikum Kassel
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Leipzig, Alemanha, 04289
- Herzzentrum - Universität Leipzig
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Ludwigshafen, Alemanha, 67073
- Herzzentrum Ludwigshafen
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Mainz, Alemanha, 55131
- Universitatsklinik Mainz
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Mannheim, Alemanha, 68167
- Universitätsklinikum Mannheim
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Suhl, Alemanha, 98527
- Zentralklinikum Suhl
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Zürich, Suíça, 8091
- UniversitätsSpital Zürich
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Critérios de participação
Critérios de elegibilidade
Idades elegíveis para estudo
Aceita Voluntários Saudáveis
Gêneros Elegíveis para o Estudo
Descrição
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.
Plano de estudo
Como o estudo é projetado?
Detalhes do projeto
- Finalidade Principal: Tratamento
- Alocação: Randomizado
- Modelo Intervencional: Atribuição Paralela
- Mascaramento: Quadruplicar
Armas e Intervenções
Grupo de Participantes / Braço |
Intervenção / Tratamento |
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Experimental: BMC
Intracoronary infusion of autologous bone marrow derived cells
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Comparador de Placebo: Placebo
Intracoronary infusion of Placebo medium
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O que o estudo está medindo?
Medidas de resultados primários
Medida de resultado |
Descrição da medida |
Prazo |
---|---|---|
Change in global left ventricular function in quantitative LV angiography after 4 months.
Prazo: 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 resultados secundários
Medida de resultado |
Descrição da medida |
Prazo |
---|---|---|
Primary endpoint in patients without restenosis.
Prazo: 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
Prazo: baseline to 4 months
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baseline to 4 months
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Reduction of LV end-systolic volume
Prazo: baseline to 4 months
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baseline to 4 months
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Major adverse cardiac events (MACE)
Prazo: 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.
Prazo: 4, 12, 60 months
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4, 12, 60 months
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NYHA status after 12 months
Prazo: 12 months
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12 months
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Amendment for extended follow up after 2 and 5 years:
Prazo: 24 and 60 months
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24 and 60 months
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outcomes in major adverse cardiac events (MACE)
Prazo: 4, 12, 60 months
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4, 12, 60 months
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Rehospitalization due to heart failure
Prazo: 4, 12, 60 months
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4, 12, 60 months
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NYHA status
Prazo: 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
Prazo: 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
- Diretor de estudo: Volker Schächinger, MD, J. W. Goethe University Hopspitals
Publicações e links úteis
Publicações Gerais
- 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.
Datas de registro do estudo
Datas Principais do Estudo
Início do estudo
Conclusão Primária (Real)
Conclusão do estudo (Real)
Datas de inscrição no estudo
Enviado pela primeira vez
Enviado pela primeira vez que atendeu aos critérios de CQ
Primeira postagem (Estimativa)
Atualizações de registro de estudo
Última Atualização Postada (Estimativa)
Última atualização enviada que atendeu aos critérios de controle de qualidade
Última verificação
Mais Informações
Termos relacionados a este estudo
Palavras-chave
Termos MeSH relevantes adicionais
Outros números de identificação do estudo
- 2/04
- Paul-Ehrlich-Institute 1034/01
- EudraCT 2006-000250-43
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