- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00389545
Intracoronary Stem Cells in Large Myocardial Infarction
October 18, 2006 updated by: Charles University, Czech Republic
Despite the widespread use of effective reperfusion therapies, the patients presenting late with large myocardial infarction have poor outcomes.
The aim of the study was to investigate the safety and efficacy of intracoronary injection of autologous bone marrow-derived mononuclear cells (BMNCs) in patients with large myocardial infarction
Study Overview
Status
Unknown
Conditions
Intervention / Treatment
Detailed Description
In the current era, up to 30% of patients with ST-segment elevation myocardial infarction, usually those presenting late, show ongoing left ventricular (LV) remodeling and poor clinical outcome despite primary percutaneous coronary intervention (PCI).
Cardiac transfer of bone marrow-derived stem and progenitor cells has been investigated as an adjunctive therapy to promote regeneration of infarcted myocardium.
Therefore, we designed a multicenter, randomized study to test the safety and efficacy of intracoronary injection of autologous BMNCs in patients with large acute anterior myocardial infarction and late presentation, who were treated with successful primary PCI.
Study Type
Interventional
Phase
- Phase 2
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 79 years (Adult, Older Adult)
Accepts Healthy Volunteers
N/A
Genders Eligible for Study
All
Description
Inclusion Criteria:
- Patients with the first ST-segment elevation acute anterior myocardial infarction due to occlusion of the proximal left anterior ascending coronary artery (LAD), who will underwent successful primary stented PCI. Patients are eligible if they have primary PCI from 4 to 12 hours after symptoms onset and show reduced LV ejection fraction ≤ 45% with at least 3 akinetic segments in the LAD perfusion territory at echocardiogram performed 24 hours after PCI.
Exclusion Criteria:
- Exclusion criteria are age ≥ 80 years, cardiogenic shock (Killip IV), multivessel coronary artery disease, serious renal or hepatic disease, blood cells disorders, documented cancer or terminal illness.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Investigators
- Principal Investigator: Martin Penicka, Charles University, Prague, Czech Republic
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Registration Dates
First Submitted
October 18, 2006
First Submitted That Met QC Criteria
October 18, 2006
First Posted (Estimate)
October 19, 2006
Study Record Updates
Last Update Posted (Estimate)
October 19, 2006
Last Update Submitted That Met QC Criteria
October 18, 2006
Last Verified
October 1, 2006
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- IGA 8225
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Myocardial Infarction
-
Azienda ULSS 5 PolesanaUniversity of PadovaUnknownMyocardial Infarction, Acute | ST Segment Elevation Myocardial Infarction | Non-ST Elevation Myocardial Infarction (nSTEMI)Italy
-
University Medical Centre LjubljanaCompletedCardiac Arrest | Postresuscitation Syndrome | Myocardial Infarction (ST-Elevation Myocardial Infarction and Non-ST-Elevation Myocardial Infarction)Slovenia
-
Fundacio Privada Mon Clinic BarcelonaMiracor Medical SANot yet recruiting
-
Stiftung Institut fuer HerzinfarktforschungGlaxoSmithKline; University Hospital Muenster; Klinikum NürnbergCompletedMyocardial Infarction | ST-Elevation Myocardial Infarction | Non-ST-Elevation Myocardial InfarctionGermany
-
Bispebjerg HospitalOdense University Hospital; Zealand University Hospital; Hvidovre University... and other collaboratorsRecruitingST Elevation Myocardial Infarction | Acute Myocardial Infarction | Non-ST Elevation Myocardial Infarction (nSTEMI)Denmark
-
Population Health Research InstituteCanadian Institutes of Health Research (CIHR); Boston Scientific CorporationActive, not recruitingST Elevation Myocardial Infarction | Non ST Elevation Myocardial InfarctionCanada
-
University of LeedsUniversity College, LondonCompletedST-elevation Myocardial Infarction | Non ST-elevation Myocardial Infarction
-
Karolinska InstitutetUppsala University; The Swedish Research CouncilActive, not recruitingST Elevation Myocardial Infarction | Acute Myocardial Infarction | Non-ST Elevation Myocardial InfarctionSweden
-
Oslo University HospitalVestre Viken Hospital Trust; University of Oslo; University Hospital of North... and other collaboratorsActive, not recruitingST Elevation Myocardial Infarction | Acute Myocardial Infarction | Non-ST Elevation Myocardial InfarctionNorway
-
Barts & The London NHS TrustUniversity College, London; Queen Mary University of LondonCompletedAcute Myocardial InfarctionSwitzerland, Denmark, United Kingdom
Clinical Trials on Intracoronary infusion of autologous bone-marrow derived stem cells
-
Johann Wolfgang Goethe University HospitalActive, not recruiting
-
Fundación Pública Andaluza Progreso y SaludIniciativa Andaluza en Terapias AvanzadasCompletedDilated CardiomyopathySpain
-
A. M. ZeiherEli Lilly and Company; Johann Wolfgang Goethe University Hospital; Guidant Corporation and other collaboratorsCompletedMyocardial InfarctionGermany, Switzerland
-
Clinica Universidad de Navarra, Universidad de...CompletedIdiopathic Pulmonary FibrosisSpain
-
Assaf-Harofeh Medical CenterCompletedChronic Ischemic Symptomatic Heart FailureIsrael
-
TCA Cellular TherapySuspendedAmyotrophic Lateral SclerosisUnited States
-
Al-Azhar UniversityHassan , Hosny , M.D. M.Sc; Samour , Hany M.D. M.Sc; Ismail , Mahmoud M.D. M.Sc; Higazy , Hasan M.D. M.Sc and other collaboratorsUnknownAge Related Macular DegenerationEgypt
-
Silesian School of MedicineMinistry of Science and Higher Education, PolandCompletedMyocardial InfarctionPoland
-
Hadassah Medical OrganizationCompletedMultiple Sclerosis
-
Xijing HospitalUnknownMyocardial InfarctionChina