Design and rationale for the Myocardial Stem Cell Administration After Acute Myocardial Infarction (MYSTAR) Study: A multicenter, prospective, randomized, single-blind trial comparing early and late intracoronary or combined (percutaneous intramyocardial and intracoronary) administration of nonselected autologous bone marrow cells to patients after acute myocardial infarction
Background Previous data suggest that bone marrow–derived stem cells (BM-SCs) decrease the infarct size and beneficially affect the postinfarction remodeling. Methods The Myocardial Stem Cell Administration After Acute Myocardial Infarction Study is a multicenter, prospective, randomized, single-bli...
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| Veröffentlicht in: | The American heart journal 2007-02, Vol.153 (2), p.212.e1-212.e7 |
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| creator | Nyolczas, Noémi, MD, FESC Gyöngyösi, Mariann, MD Beran, Gilbert, MD Dettke, Markus, MD Graf, Senta, MD Sochor, Heinz, MD, FESC Christ, Günther, MD Édes, István, MD, PhD, FESC Balogh, László, MD Krause, Korff T., MD Jaquet, Kai, MD Kuck, Karl-Heinz, MD Benedek, Imre, MD Hintea, Theodora, MD Kiss, Róbert, MD, PhD Préda, István, MD, PhD, FESC Kotevski, Vladimir, MD, FESC Pejkov, Hristo, MD Dudek, Darius, MD Heba, Grzegorz, MD Sylven, Christer, MD Charwat, Silvia, MD Jacob, Ronaldo, MD Maurer, Gerald, MD, FACC Lang, Irene, MD Glogar, Dietmar, MD, FESC |
| description | Background Previous data suggest that bone marrow–derived stem cells (BM-SCs) decrease the infarct size and beneficially affect the postinfarction remodeling. Methods The Myocardial Stem Cell Administration After Acute Myocardial Infarction Study is a multicenter, prospective, randomized, single-blind clinical trial designed to compare the early and late intracoronary or combined (percutaneous intramyocardial and intracoronary) administration of BM-SCs to patients after acute myocardial infarction (AMI) with reopened infarct-related artery. The primary end points are the changes in resting myocardial perfusion defect size and left ventricular ejection fraction (gated single photon emission computed tomography [SPECT] scintigraphy) 3 months after BM-SCs therapy. The secondary end points relate to evaluation of (1) the safety and feasibility of the application modes, (2) the changes in left ventricular wall motion score index (transthoracic echocardiography), (3) myocardial voltage and segmental wall motion (NOGA mapping), (4) left ventricular end-diastolic and end-systolic volumes (contrast ventriculography), and (5) the clinical symptoms (Canadian Cardiovascular Society [CCS] anina score and New York Heart Association [NYHA] functional class) at follow-up. Three hundred sixty patients are randomly assigned into 1 of 4 groups: group A, early treatment (21-42 days after AMI) with intracoronary injection; group B, early treatment with combined application; group C, late treatment (3 months after AMI) with intracoronary delivery; and group D, late treatment with combined administration of BM-SCs. Besides the BM-SCs therapy, the standardized treatment of AMI is applied in all patients. Conclusions The Myocardial Stem Cell Administration After Acute Myocardial Infarction Trial is the first randomized trial to investigate the effects of the combined (intramyocardial and intracoronary) and the intracoronary mode of delivery of BM-SCs therapy in the early and late periods after AMI. |
| doi_str_mv | 10.1016/j.ahj.2006.10.027 |
| format | Article |
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Methods The Myocardial Stem Cell Administration After Acute Myocardial Infarction Study is a multicenter, prospective, randomized, single-blind clinical trial designed to compare the early and late intracoronary or combined (percutaneous intramyocardial and intracoronary) administration of BM-SCs to patients after acute myocardial infarction (AMI) with reopened infarct-related artery. The primary end points are the changes in resting myocardial perfusion defect size and left ventricular ejection fraction (gated single photon emission computed tomography [SPECT] scintigraphy) 3 months after BM-SCs therapy. The secondary end points relate to evaluation of (1) the safety and feasibility of the application modes, (2) the changes in left ventricular wall motion score index (transthoracic echocardiography), (3) myocardial voltage and segmental wall motion (NOGA mapping), (4) left ventricular end-diastolic and end-systolic volumes (contrast ventriculography), and (5) the clinical symptoms (Canadian Cardiovascular Society [CCS] anina score and New York Heart Association [NYHA] functional class) at follow-up. Three hundred sixty patients are randomly assigned into 1 of 4 groups: group A, early treatment (21-42 days after AMI) with intracoronary injection; group B, early treatment with combined application; group C, late treatment (3 months after AMI) with intracoronary delivery; and group D, late treatment with combined administration of BM-SCs. Besides the BM-SCs therapy, the standardized treatment of AMI is applied in all patients. Conclusions The Myocardial Stem Cell Administration After Acute Myocardial Infarction Trial is the first randomized trial to investigate the effects of the combined (intramyocardial and intracoronary) and the intracoronary mode of delivery of BM-SCs therapy in the early and late periods after AMI.</description><identifier>ISSN: 0002-8703</identifier><identifier>EISSN: 1097-6744</identifier><identifier>DOI: 10.1016/j.ahj.2006.10.027</identifier><identifier>PMID: 17239678</identifier><identifier>CODEN: AHJOA2</identifier><language>eng</language><publisher>United States: Mosby, Inc</publisher><subject>Bone marrow ; Bone Marrow Transplantation - methods ; Cardiovascular ; Coronary Vessels ; Heart attacks ; Humans ; Multicenter Studies as Topic ; Myocardial Infarction - surgery ; Myocardium ; Prospective Studies ; Research Design ; Single-Blind Method ; Stem cells ; Studies ; Time Factors ; Transplants & implants</subject><ispartof>The American heart journal, 2007-02, Vol.153 (2), p.212.e1-212.e7</ispartof><rights>Mosby, Inc.</rights><rights>2007 Mosby, Inc.</rights><rights>Copyright Elsevier Limited Feb 2007</rights><lds50>peer_reviewed</lds50><woscitedreferencessubscribed>false</woscitedreferencessubscribed><citedby>FETCH-LOGICAL-c538t-8768bbcc3c5ceb9bea4aff8f21de1953ee023d2b0c53d2b7a9725f1e4fdcc9d3</citedby><cites>FETCH-LOGICAL-c538t-8768bbcc3c5ceb9bea4aff8f21de1953ee023d2b0c53d2b7a9725f1e4fdcc9d3</cites></display><links><openurl>$$Topenurl_article</openurl><openurlfulltext>$$Topenurlfull_article</openurlfulltext><thumbnail>$$Tsyndetics_thumb_exl</thumbnail><linktohtml>$$Uhttps://www.sciencedirect.com/science/article/pii/S0002870306009483$$EHTML$$P50$$Gelsevier$$H</linktohtml><link.rule.ids>230,314,776,780,881,3537,27901,27902,65534</link.rule.ids><backlink>$$Uhttps://www.ncbi.nlm.nih.gov/pubmed/17239678$$D View this record in MEDLINE/PubMed$$Hfree_for_read</backlink><backlink>$$Uhttp://kipublications.ki.se/Default.aspx?queryparsed=id:13947454$$DView record from Swedish Publication Index$$Hfree_for_read</backlink></links><search><creatorcontrib>Nyolczas, Noémi, MD, FESC</creatorcontrib><creatorcontrib>Gyöngyösi, Mariann, MD</creatorcontrib><creatorcontrib>Beran, Gilbert, MD</creatorcontrib><creatorcontrib>Dettke, Markus, MD</creatorcontrib><creatorcontrib>Graf, Senta, MD</creatorcontrib><creatorcontrib>Sochor, Heinz, MD, FESC</creatorcontrib><creatorcontrib>Christ, Günther, MD</creatorcontrib><creatorcontrib>Édes, István, MD, PhD, FESC</creatorcontrib><creatorcontrib>Balogh, László, MD</creatorcontrib><creatorcontrib>Krause, Korff T., MD</creatorcontrib><creatorcontrib>Jaquet, Kai, MD</creatorcontrib><creatorcontrib>Kuck, Karl-Heinz, MD</creatorcontrib><creatorcontrib>Benedek, Imre, MD</creatorcontrib><creatorcontrib>Hintea, Theodora, MD</creatorcontrib><creatorcontrib>Kiss, Róbert, MD, PhD</creatorcontrib><creatorcontrib>Préda, István, MD, PhD, FESC</creatorcontrib><creatorcontrib>Kotevski, Vladimir, MD, FESC</creatorcontrib><creatorcontrib>Pejkov, Hristo, MD</creatorcontrib><creatorcontrib>Dudek, Darius, MD</creatorcontrib><creatorcontrib>Heba, Grzegorz, MD</creatorcontrib><creatorcontrib>Sylven, Christer, MD</creatorcontrib><creatorcontrib>Charwat, Silvia, MD</creatorcontrib><creatorcontrib>Jacob, Ronaldo, MD</creatorcontrib><creatorcontrib>Maurer, Gerald, MD, FACC</creatorcontrib><creatorcontrib>Lang, Irene, MD</creatorcontrib><creatorcontrib>Glogar, Dietmar, MD, FESC</creatorcontrib><title>Design and rationale for the Myocardial Stem Cell Administration After Acute Myocardial Infarction (MYSTAR) Study: A multicenter, prospective, randomized, single-blind trial comparing early and late intracoronary or combined (percutaneous intramyocardial and intracoronary) administration of nonselected autologous bone marrow cells to patients after acute myocardial infarction</title><title>The American heart journal</title><addtitle>Am Heart J</addtitle><description>Background Previous data suggest that bone marrow–derived stem cells (BM-SCs) decrease the infarct size and beneficially affect the postinfarction remodeling. Methods The Myocardial Stem Cell Administration After Acute Myocardial Infarction Study is a multicenter, prospective, randomized, single-blind clinical trial designed to compare the early and late intracoronary or combined (percutaneous intramyocardial and intracoronary) administration of BM-SCs to patients after acute myocardial infarction (AMI) with reopened infarct-related artery. The primary end points are the changes in resting myocardial perfusion defect size and left ventricular ejection fraction (gated single photon emission computed tomography [SPECT] scintigraphy) 3 months after BM-SCs therapy. The secondary end points relate to evaluation of (1) the safety and feasibility of the application modes, (2) the changes in left ventricular wall motion score index (transthoracic echocardiography), (3) myocardial voltage and segmental wall motion (NOGA mapping), (4) left ventricular end-diastolic and end-systolic volumes (contrast ventriculography), and (5) the clinical symptoms (Canadian Cardiovascular Society [CCS] anina score and New York Heart Association [NYHA] functional class) at follow-up. Three hundred sixty patients are randomly assigned into 1 of 4 groups: group A, early treatment (21-42 days after AMI) with intracoronary injection; group B, early treatment with combined application; group C, late treatment (3 months after AMI) with intracoronary delivery; and group D, late treatment with combined administration of BM-SCs. Besides the BM-SCs therapy, the standardized treatment of AMI is applied in all patients. Conclusions The Myocardial Stem Cell Administration After Acute Myocardial Infarction Trial is the first randomized trial to investigate the effects of the combined (intramyocardial and intracoronary) and the intracoronary mode of delivery of BM-SCs therapy in the early and late periods after AMI.</description><subject>Bone marrow</subject><subject>Bone Marrow Transplantation - methods</subject><subject>Cardiovascular</subject><subject>Coronary Vessels</subject><subject>Heart attacks</subject><subject>Humans</subject><subject>Multicenter Studies as Topic</subject><subject>Myocardial Infarction - surgery</subject><subject>Myocardium</subject><subject>Prospective Studies</subject><subject>Research Design</subject><subject>Single-Blind Method</subject><subject>Stem cells</subject><subject>Studies</subject><subject>Time Factors</subject><subject>Transplants & 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Pharma Collection</collection><collection>Public Health Database</collection><collection>Technology Research Database</collection><collection>Hospital Premium Collection</collection><collection>Hospital Premium Collection (Alumni Edition)</collection><collection>ProQuest Central (Alumni) (purchase pre-March 2016)</collection><collection>Research Library (Alumni Edition)</collection><collection>ProQuest Central (Alumni Edition)</collection><collection>ProQuest Central UK/Ireland</collection><collection>British Nursing Database</collection><collection>ProQuest Central Essentials</collection><collection>ProQuest Central</collection><collection>ProQuest One Community College</collection><collection>ProQuest Central Korea</collection><collection>Engineering Research Database</collection><collection>Health Research Premium Collection</collection><collection>Health Research Premium Collection (Alumni)</collection><collection>ProQuest Central Student</collection><collection>Research Library Prep</collection><collection>ProQuest Health & Medical Complete (Alumni)</collection><collection>Nursing & Allied Health Database (Alumni Edition)</collection><collection>Health & Medical Collection (Alumni Edition)</collection><collection>Healthcare Administration Database</collection><collection>Medical Database</collection><collection>Research Library</collection><collection>Research Library (Corporate)</collection><collection>Nursing & Allied Health Premium</collection><collection>Biotechnology and BioEngineering Abstracts</collection><collection>ProQuest One Academic Eastern Edition (DO NOT USE)</collection><collection>ProQuest One Academic</collection><collection>ProQuest One Academic UKI Edition</collection><collection>ProQuest Central China</collection><collection>ProQuest Central Basic</collection><collection>MEDLINE - Academic</collection><collection>SwePub</collection><collection>SwePub Articles</collection><jtitle>The American heart journal</jtitle></facets><delivery><delcategory>Remote Search Resource</delcategory><fulltext>fulltext</fulltext></delivery><addata><au>Nyolczas, Noémi, MD, FESC</au><au>Gyöngyösi, Mariann, MD</au><au>Beran, Gilbert, MD</au><au>Dettke, Markus, MD</au><au>Graf, Senta, MD</au><au>Sochor, Heinz, MD, FESC</au><au>Christ, Günther, MD</au><au>Édes, István, MD, PhD, FESC</au><au>Balogh, László, MD</au><au>Krause, Korff T., MD</au><au>Jaquet, Kai, MD</au><au>Kuck, Karl-Heinz, MD</au><au>Benedek, Imre, MD</au><au>Hintea, Theodora, MD</au><au>Kiss, Róbert, MD, PhD</au><au>Préda, István, MD, PhD, FESC</au><au>Kotevski, Vladimir, MD, FESC</au><au>Pejkov, Hristo, MD</au><au>Dudek, Darius, MD</au><au>Heba, Grzegorz, MD</au><au>Sylven, Christer, MD</au><au>Charwat, Silvia, MD</au><au>Jacob, Ronaldo, MD</au><au>Maurer, Gerald, MD, FACC</au><au>Lang, Irene, MD</au><au>Glogar, Dietmar, MD, FESC</au><format>journal</format><genre>article</genre><ristype>JOUR</ristype><atitle>Design and rationale for the Myocardial Stem Cell Administration After Acute Myocardial Infarction (MYSTAR) Study: A multicenter, prospective, randomized, single-blind trial comparing early and late intracoronary or combined (percutaneous intramyocardial and intracoronary) administration of nonselected autologous bone marrow cells to patients after acute myocardial infarction</atitle><jtitle>The American heart journal</jtitle><addtitle>Am Heart J</addtitle><date>2007-02-01</date><risdate>2007</risdate><volume>153</volume><issue>2</issue><spage>212.e1</spage><epage>212.e7</epage><pages>212.e1-212.e7</pages><issn>0002-8703</issn><eissn>1097-6744</eissn><coden>AHJOA2</coden><abstract>Background Previous data suggest that bone marrow–derived stem cells (BM-SCs) decrease the infarct size and beneficially affect the postinfarction remodeling. Methods The Myocardial Stem Cell Administration After Acute Myocardial Infarction Study is a multicenter, prospective, randomized, single-blind clinical trial designed to compare the early and late intracoronary or combined (percutaneous intramyocardial and intracoronary) administration of BM-SCs to patients after acute myocardial infarction (AMI) with reopened infarct-related artery. The primary end points are the changes in resting myocardial perfusion defect size and left ventricular ejection fraction (gated single photon emission computed tomography [SPECT] scintigraphy) 3 months after BM-SCs therapy. The secondary end points relate to evaluation of (1) the safety and feasibility of the application modes, (2) the changes in left ventricular wall motion score index (transthoracic echocardiography), (3) myocardial voltage and segmental wall motion (NOGA mapping), (4) left ventricular end-diastolic and end-systolic volumes (contrast ventriculography), and (5) the clinical symptoms (Canadian Cardiovascular Society [CCS] anina score and New York Heart Association [NYHA] functional class) at follow-up. Three hundred sixty patients are randomly assigned into 1 of 4 groups: group A, early treatment (21-42 days after AMI) with intracoronary injection; group B, early treatment with combined application; group C, late treatment (3 months after AMI) with intracoronary delivery; and group D, late treatment with combined administration of BM-SCs. Besides the BM-SCs therapy, the standardized treatment of AMI is applied in all patients. Conclusions The Myocardial Stem Cell Administration After Acute Myocardial Infarction Trial is the first randomized trial to investigate the effects of the combined (intramyocardial and intracoronary) and the intracoronary mode of delivery of BM-SCs therapy in the early and late periods after AMI.</abstract><cop>United States</cop><pub>Mosby, Inc</pub><pmid>17239678</pmid><doi>10.1016/j.ahj.2006.10.027</doi></addata></record> |
| fulltext | fulltext |
| identifier | ISSN: 0002-8703 |
| ispartof | The American heart journal, 2007-02, Vol.153 (2), p.212.e1-212.e7 |
| issn | 0002-8703 1097-6744 |
| language | eng |
| recordid | cdi_swepub_primary_oai_swepub_ki_se_572027 |
| source | MEDLINE; Elsevier ScienceDirect Journals |
| subjects | Bone marrow Bone Marrow Transplantation - methods Cardiovascular Coronary Vessels Heart attacks Humans Multicenter Studies as Topic Myocardial Infarction - surgery Myocardium Prospective Studies Research Design Single-Blind Method Stem cells Studies Time Factors Transplants & implants |
| title | Design and rationale for the Myocardial Stem Cell Administration After Acute Myocardial Infarction (MYSTAR) Study: A multicenter, prospective, randomized, single-blind trial comparing early and late intracoronary or combined (percutaneous intramyocardial and intracoronary) administration of nonselected autologous bone marrow cells to patients after acute myocardial infarction |
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