Condition category
Circulatory System
Date applied
20/12/2005
Date assigned
20/12/2005
Last edited
10/10/2014
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

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

Sponsor information

Organisation

Interuniversity Cardiology Institute of the Netherlands (ICIN) (Netherlands)

Sponsor details

P.O. Box 19258
Utrecht
3501 DG
Netherlands

Sponsor type

Research organisation

Website

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

  1. 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.

  2. 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.

Additional files

Editorial Notes