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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

About this trial

This is an interventional treatment trial for Myocardial Infarction focused on measuring First large acute myocardial infarction

Eligibility Criteria

20 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

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Primary Completion Date

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Study Completion Date

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3. Sponsor/Collaborators

Name of the Sponsor

University Hospital, Antwerp

4. Oversight

Data Monitoring Committee

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

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

steven.haine@uza.be

First Name & Middle Initial & Last Name or Official Title & Degree

Myriam Michiels, Nurse

Phone

0032.3.821.33.04

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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