Intracoronary Infusion of BM-Derived Mononuclear Cells in Patients With Large Acute Myocardial Infarction
Primary Purpose
Myocardial Infarction
Status
Unknown status
Phase
Phase 2
Locations
Belgium
Study Type
Interventional
Intervention
Intracoronary mononuclear cell infusion
Sponsored by
About this trial
This is an interventional treatment trial for Myocardial Infarction focused on measuring First large acute myocardial infarction
Eligibility Criteria
Inclusion Criteria:
- Age ≥20 and <80 years old
- Acute myocardial infarction >2 and <96 hours from start to reperfusion
- Cumulative ST-segment elevation >6 mm on 12 lead ECG
- No functional myocardial impairment outside the myocardial infarction region
- Succesful PCI of infarct related coronary artery
- Left ventricular ejection fraction <50% on ventriculography, echo or MRI
- Accepted anticonceptive use during the study for women of childbearing potential
- Written and signed informed consent
Exclusion Criteria:
- CPR > 10 minuts or persistent cardiogenic shock
- complete left bundle branch block without concordant ST-segment elevation
- Need foor cardiac surgery (valvular, coronary or other)
- Trombocytopenia, coagulation disorders or hematological disease
- History or active malignancy
- Life expectancy (apart from acute myocardial infarction) <5 years
- Dialysis or severe kidney insufficiency (creatinin clearance <30ml/')
- Severe liver insufficiency
- Severe respiratory disease
- Systemic inflammatory pathology (acute or chronic, apart from inflammation associated with myocardial infarction)
- Symptomatic cerebral or periferal vascular disease
- Prior myocardial infarction or prior myocardial dysfunction
- Prior CABG or heart valve surgery
- Pregnancy, pregnancy wish or lactation <1 month
- Psychiatrical illness
- Physical or psychological inability to adhere to the protocol
- Participation in other not yet completed study
Sites / Locations
- Universitair Ziekenhuis AntwerpenRecruiting
Outcomes
Primary Outcome Measures
Secondary Outcome Measures
Full Information
NCT ID
NCT00497211
First Posted
July 4, 2007
Last Updated
July 5, 2007
Sponsor
University Hospital, Antwerp
1. Study Identification
Unique Protocol Identification Number
NCT00497211
Brief Title
Intracoronary Infusion of BM-Derived Mononuclear Cells in Patients With Large Acute Myocardial Infarction
Study Type
Interventional
2. Study Status
Record Verification Date
July 2007
Overall Recruitment Status
Unknown status
Study Start Date
undefined (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
undefined (undefined)
3. Sponsor/Collaborators
Name of the Sponsor
University Hospital, Antwerp
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
Large acute myocardial infarctions are the most frequent cause of subsequent systolic heart failure. Some evidence exists on the improvement after intracoronary administration of bone marrow cells in patients with a recente acute myocardial infarction. Although subgroup analyses suggest that patients with the largest myocardial infarctions have the largest increase in ejection fraction after intracoronary bone marrow administration, there is no published trial including only large myocardial infarctions. Therefor we sought to confirm the subgroup analyses by conducting a trial in only large first acute myocardial infarction patients.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Myocardial Infarction
Keywords
First large acute myocardial infarction
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2, Phase 3
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
8. Arms, Groups, and Interventions
Intervention Type
Procedure
Intervention Name(s)
Intracoronary mononuclear cell infusion
10. Eligibility
Sex
All
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Age ≥20 and <80 years old
Acute myocardial infarction >2 and <96 hours from start to reperfusion
Cumulative ST-segment elevation >6 mm on 12 lead ECG
No functional myocardial impairment outside the myocardial infarction region
Succesful PCI of infarct related coronary artery
Left ventricular ejection fraction <50% on ventriculography, echo or MRI
Accepted anticonceptive use during the study for women of childbearing potential
Written and signed informed consent
Exclusion Criteria:
CPR > 10 minuts or persistent cardiogenic shock
complete left bundle branch block without concordant ST-segment elevation
Need foor cardiac surgery (valvular, coronary or other)
Trombocytopenia, coagulation disorders or hematological disease
History or active malignancy
Life expectancy (apart from acute myocardial infarction) <5 years
Dialysis or severe kidney insufficiency (creatinin clearance <30ml/')
Severe liver insufficiency
Severe respiratory disease
Systemic inflammatory pathology (acute or chronic, apart from inflammation associated with myocardial infarction)
Symptomatic cerebral or periferal vascular disease
Prior myocardial infarction or prior myocardial dysfunction
Prior CABG or heart valve surgery
Pregnancy, pregnancy wish or lactation <1 month
Psychiatrical illness
Physical or psychological inability to adhere to the protocol
Participation in other not yet completed study
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Steven E Haine, MD
Phone
0032.3.821.42.81
Email
steven.haine@uza.be
First Name & Middle Initial & Last Name or Official Title & Degree
Myriam Michiels, Nurse
Phone
0032.3.821.33.04
Email
Myriam.michiels@uza.be
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Steven E Haine, MD
Organizational Affiliation
UZ Antwerpen
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Chris Vrints, MD, PhD
Organizational Affiliation
UZ Antwerpen
Official's Role
Study Director
Facility Information:
Facility Name
Universitair Ziekenhuis Antwerpen
City
Edegem
ZIP/Postal Code
2650
Country
Belgium
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Johan Bosmans, MD, PhD
First Name & Middle Initial & Last Name & Degree
Marc Claeys, MD, PhD
First Name & Middle Initial & Last Name & Degree
Hielko Miljoen, MD, PhD
12. IPD Sharing Statement
Learn more about this trial
Intracoronary Infusion of BM-Derived Mononuclear Cells in Patients With Large Acute Myocardial Infarction
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