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ISRCTN
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ISRCTN95796863
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ClinicalTrials.gov identifier
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Public title
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Multicenter, randomised trial of intracoronary infusion of autologous mononuclear bone marrow cells or peripheral mononuclear blood cells after primary percutaneous coronary intervention (PCI)
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Scientific title
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Acronym
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HEBE-trial
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Serial number at source
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NTR166
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Study hypothesis
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The primary objective of this study is to determine whether intracoronary infusion of autologous mononuclear bone marrow cells or peripheral mononuclear blood cells provides improved recovery of regional left ventricular function after an acute, large myocardial infarction treated by percutaneous coronary intervention (PCI) compared to standard therapy.
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Lay summary
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Not provided at time of registration
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Ethics approval
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Not provided at time of registration
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Study design
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Randomised controlled trial
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Countries of recruitment
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Netherlands
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Disease/condition/study domain
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Acute myocardial infarction
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Participants - inclusion criteria
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1. PCI within 12 hours of onset of symptoms
2. Successful treatment of a culprit lesion in the left anterior descending (LAD), right coronary artery (RCA) or ramus circumflexus (RCX)
3. At least one creatine kinase (CK) and/or creatine kina-myocardial bands (CK-MB) measurement 10 times higher than the local upper limit of normal (ULN)
4. Hypokinesia or akinesia of greater than or equal to three segments using a 16-segment model documented by routine resting echocardiography at least 12 hours after primary PCI
5. Clinically and haemodynamically stable over the previous 12 hours
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Participants - exclusion criteria
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1. Less than 30 or greater than 70 years of age
2. Anticipated percutaneous or surgical coronary intervention within the next four months
3. Presence of supraventricular or ventricular arrhythmias
4. Left ventricular (LV) ejection fraction less than 45% prior to current admission for myocardial infarction
5. Stroke or transient ischaemic attack within the previous 24 hours
6. Any contraindication for magnetic resonance imaging (MRI)
7. Positive for human immunodeficiency virus (HIV), hepatitis B virus (HBV) or hepatitis C virus (HCV) infection
8. Serious known concomitant disease with a life expectancy of less than one year
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Anticipated start date
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23/06/2005
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Anticipated end date
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01/07/2007
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Status of trial
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Completed |
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Patient information material
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Target number of participants
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200
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Interventions
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After written informed consent has been obtained, MRI measurements and echocardiography are performed minimally 48 hours after PCI. Patients are randomised to a treatment with:
1. Intracoronary infusion of autologous mononuclear bone marrow cells
2. Intracoronary infusion of peripheral mononuclear blood cells
3. Standard therapy
If applicable, bone marrow is aspirated from the iliac crest under local anaesthesia or venous blood is collected. Mononuclear cells are isolated from the aspirate or blood by density gradient centrifugation. Within 7 days after PCI and within 24 hours after bone marrow aspiration or venous blood collection, a catheterisation for the intracoronary infusion of the autologous mononuclear cells in the infarct related coronary artery is performed. In all patients the follow up is at 1, 4 and 12 months. The MRI measurements and catheterisation are repeated at 4 months.
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Primary outcome measure(s)
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The change of regional myocardial function based on a MRI-segmental analysis at four months relative to baseline.
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Secondary outcome measure(s)
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1. Functional: change of LV ejection fraction at four months relative to baseline, measured by MRI and echocardiography, and change in global and regional wall motion severity index (WMSI) measured by echocardiography at 4 months and 12 months relative to baseline
2. Infarct related: change of infarct size at 4 months relative to baseline, measured by MRI
3. Clinical: occurrence within 4 and 12 months of a major adverse cardiac events
4. Angiograpic: the presence of in-stent restenosis and late luminal loss
5. Change of intracoronary haemodynamic parameters at 4 months relative to baseline
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Sources of funding
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Interuniversity Cardiology Institute of the Netherlands (ICIN) (Netherlands)
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Trial website
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Publications
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1. 2011 results in http://eurheartj.oxfordjournals.org/content/32/14/1736
2. 2011 rersults in http://www.ncbi.nlm.nih.gov/pubmed/21851907
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Contact name
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Prof
J.J.
Piek
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Address
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Academic Medical Center Amsterdam,
Department of Cardiology,
Meibergdreef 9
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City/town
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Amsterdam
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Zip/Postcode
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1105 AZ
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Country
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Netherlands
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Tel
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+31 (0)20 5663072
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Email
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j.j.piek@amc.uva.nl
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Sponsor
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Interuniversity Cardiology Institute of the Netherlands (ICIN) (Netherlands)
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Address
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P.O. Box 19258
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City/town
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Utrecht
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Zip/Postcode
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3501 DG
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Country
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Netherlands
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Date applied
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20/12/2005
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Last edited
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03/01/2012
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Date ISRCTN assigned
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20/12/2005
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