Multicenter, randomised trial of intracoronary infusion of autologous mononuclear bone marrow cells or peripheral mononuclear blood cells after primary percutaneous coronary intervention (PCI)
| ISRCTN | ISRCTN95796863 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN95796863 |
| Secondary identifying numbers | NTR166 |
- Submission date
- 20/12/2005
- Registration date
- 20/12/2005
- Last edited
- 10/10/2014
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Circulatory System
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data
Plain English summary of protocol
Not provided at time of registration
Contact information
Prof J.J. Piek
Scientific
Scientific
Academic Medical Center Amsterdam
Department of Cardiology
Meibergdreef 9
Amsterdam
1105 AZ
Netherlands
| Phone | +31 (0)20 5663072 |
|---|---|
| j.j.piek@amc.uva.nl |
Study information
| Study design | Randomised controlled trial |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Hospital |
| Study type | Treatment |
| Scientific title | |
| Study acronym | HEBE |
| Study objectives | 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(s) | Not provided at time of registration |
| Health condition(s) or problem(s) studied | 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 |
| Primary outcome measure | 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 study start date | 23/06/2005 |
| Completion date | 01/07/2007 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Sex | Both |
| Target number of participants | 200 |
| Key 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 |
| Key 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 |
| Date of first enrolment | 23/06/2005 |
| Date of final enrolment | 01/07/2007 |
Locations
Countries of recruitment
- Netherlands
Study participating centre
Academic Medical Center Amsterdam,
Amsterdam
1105 AZ
Netherlands
1105 AZ
Netherlands
Sponsor information
Interuniversity Cardiology Institute of the Netherlands (ICIN) (Netherlands)
Research organisation
Research organisation
P.O. Box 19258
Utrecht
3501 DG
Netherlands
"ROR" |
https://ror.org/01mh6b283 |
|---|
Funders
Funder type
University/education
Interuniversity Cardiology Institute of the Netherlands (ICIN) (Netherlands)
No information available
Results and Publications
| Intention to publish date | |
|---|---|
| Individual participant data (IPD) Intention to share | No |
| IPD sharing plan summary | Not provided at time of registration |
| Publication and dissemination plan | Not provided at time of registration |
| IPD sharing plan |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Results article | results | 01/07/2011 | Yes | No | |
| Results article | results | 01/08/2011 | Yes | No | |
| Results article | results | 01/03/2015 | Yes | No |
