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

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

NL-OMON

Registry ID

NL-OMON27593

Enrollment

200

Registered

2005-08-30

Start date

2005-06-23

Completion date

Unknown

Last updated

2024-02-28

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Acute myocardial infarction

Interventions

After 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 infusi

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

Eligibility

Inclusion criteria

Inclusion criteria: 1. 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 criteria

Exclusion criteria: 1. 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.

Design outcomes

Primary

Measure	Time frame
The change of regional myocardial function based on a MRI-segmental analysis at 4 months relative to baseline.	—

Secondary

Measure	Time frame
Functional: 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.	—

Measure

Time frame

Functional: 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.

—

Contacts

Public ContactJ.J. Piek

Academic Medical Center Amsterdam (AMC), Department of Cardiology, P.O. Box 22660

j.j.piek@amc.uva.nl+31 (0)20 5663072

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)