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Multicenter, randomized trial of intracoronary infusion of autologous mononuclear bone marrow cells or peripheral mononuclear blood cells after primary PCI.


- candidate number1281
- NTR NumberNTR166
- ISRCTNISRCTN95796863
- Date ISRCTN created20-dec-2005
- date ISRCTN requested18-okt-2005
- Date Registered NTR30-aug-2005
- Secondary IDsN/A 
- Public TitleMulticenter, randomized trial of intracoronary infusion of autologous mononuclear bone marrow cells or peripheral mononuclear blood cells after primary PCI.
- Scientific TitleMulticenter, randomized trial of intracoronary infusion of autologous mononuclear bone marrow cells or peripheral mononuclear blood cells after primary PCI.
- ACRONYMHEBE-trial
- hypothesisThe 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 PCI compared to standard therapy.
- Healt Condition(s) or Problem(s) studiedAcute myocardial infarction
- Inclusion criteria1. PCI within 12 hours of onset of symptoms;
2. Successful treatment of a culprit lesion in the LAD, RCA or RCX;
3. At least one CK and/or CK-MB measurement 10 times higher than the local ULN;
4. hypokinesia or akinesia of >=3 segments using a 16-segment model documented by routine resting echocardiography at least 12 hours after primary PCI;
5. Clinically and hemodynamically stable over the previous 12 hours.
- Exclusion criteria1. <30 or >70 years of age;
2. Anticipated percutaneous or surgical coronary intervention within the next 4 months;
3. Presence of supraventricular or ventricular arrhythmias;
4. LV ejection fraction < 45% prior to current admission for myocardial infarction;
5. Stroke or transient ischemic attack within the previous 24 hours;
6. Any contraindication for MRI;
7. Positive for HIV, HBV or HCV infection;
8. Serious known concomitant disease with a life expectancy of less than one year.
- mec approval receivedyes
- multicenter trialyes
- randomisedyes
- masking/blindingNone
- controlActive
- groupParallel
- Type2 or more arms, randomized
- Studytypeintervention
- planned startdate 23-jun-2005
- planned closingdate1-jul-2007
- Target number of participants200
- InterventionsAfter written informed consent has been obtained, MRI measurements and echocardiography are performed minimally 48 hours after PCI. Patients are randomized to a treatment with
1. Intracoronary infusion of autologous mononuclear bone marrow cells;
2. Intracoronary infusion of peripheral mononuclear blood cells; or
3. Standard therapy.
If applicable, bone marrow is aspirated from the iliac crest under local anesthesia 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 catheterization 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 catheterization are repeated at 4 months.
- Primary outcomeThe change of regional myocardial function based on a MRI-segmental analysis at 4 months relative to baseline.
- Secondary outcomeFunctional:
change of LV ejection fraction at 4 months relative to baseline, measured by MRI and echocardiography, and change in global and regional WMSI measured by echocardiography at 4 months and 12 months relative to baseline;

Infarct related:
change of infarct size at 4 months relative to baseline, measured by MRI;

Clinical:
occurrence within 4 and 12 months of a major adverse cardiac events;

Angiograpic:
the presence of in-stent restenosis and late luminal loss;

Change:
of intracoronary hemodynamic parameters at 4 months relative to baseline.
- TimepointsN/A
- Trial web siteN/A
- statusinclusion stopped: follow-up
- CONTACT FOR PUBLIC QUERIESProf. Dr. J.J. Piek
- CONTACT for SCIENTIFIC QUERIESProf. Dr. J.J. Piek
- Sponsor/Initiator Interuniversity Cardiology Institute of the Netherlands (ICIN)
- Funding
(Source(s) of Monetary or Material Support)
Interuniversity Institute of Cardiology (ICIN), The Netherlands
- PublicationsN/A
- Brief summaryN/A
- Main changes (audit trail)
- RECORD23-aug-2005 - 2-dec-2009


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