Contact information
Type
Scientific
Primary contact
Prof J.J. Piek
ORCID ID
Contact details
Academic Medical Center Amsterdam
Department of Cardiology
Meibergdreef 9
Amsterdam
1105 AZ
Netherlands
+31 (0)20 5663072
j.j.piek@amc.uva.nl
Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
NTR166
Study information
Scientific title
Acronym
HEBE
Study hypothesis
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.
Ethics approval
Not provided at time of registration
Study design
Randomised controlled trial
Primary study design
Interventional
Secondary study design
Randomised controlled trial
Trial setting
Hospitals
Trial type
Treatment
Patient information sheet
Condition
Acute myocardial infarction
Intervention
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.
Intervention type
Other
Phase
Not Specified
Drug names
Primary outcome measures
The change of regional myocardial function based on a MRI-segmental analysis at four months relative to baseline.
Secondary outcome measures
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
Overall trial start date
23/06/2005
Overall trial end date
01/07/2007
Reason abandoned
Eligibility
Participant inclusion criteria
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
Participant type
Patient
Age group
Adult
Gender
Both
Target number of participants
200
Participant exclusion criteria
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
Recruitment start date
23/06/2005
Recruitment end date
01/07/2007
Locations
Countries of recruitment
Netherlands
Trial participating centre
Academic Medical Center Amsterdam,
Amsterdam
1105 AZ
Netherlands
Funders
Funder type
University/education
Funder name
Interuniversity Cardiology Institute of the Netherlands (ICIN) (Netherlands)
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
Results and Publications
Publication and dissemination plan
Not provided at time of registration
Intention to publish date
Participant level data
Not provided at time of registration
Results - basic reporting
Publication summary
2011 results in: http://eurheartj.oxfordjournals.org/content/32/14/1736
2011 results in: http://www.ncbi.nlm.nih.gov/pubmed/21851907
2014 results in: http://www.ncbi.nlm.nih.gov/pubmed/25294647
Publication citations
-
Results
van der Laan AM, Hirsch A, Haeck JD, Nijveldt R, Delewi R, Biemond BJ, Tijssen JG, Marques KM, Zijlstra F, van Rossum AC, Piek JJ, Recovery of microcirculation after intracoronary infusion of bone marrow mononuclear cells or peripheral blood mononuclear cells in patients treated by primary percutaneous coronary intervention the Doppler substudy of the Hebe trial., JACC Cardiovasc Interv, 2011, 4, 8, 913-920, doi: 10.1016/j.jcin.2011.05.005.
-
Results
Delewi R, van der Laan AM, Robbers LF, Hirsch A, Nijveldt R, van der Vleuten PA, Tijssen JG, Tio RA, Waltenberger J, Ten Berg JM, Doevendans PA, Gehlmann HR, van Rossum AC, Piek JJ, Zijlstra F, , Long term outcome after mononuclear bone marrow or peripheral blood cells infusion after myocardial infarction., Heart, 2014, doi: 10.1136/heartjnl-2014-305892.