Intracoronary Infusion of BM-Derived Mononuclear Cells in Patients With Large Acute Myocardial Infarction

This study is currently recruiting participants.

Verified by University Hospital, Antwerp, July 2007

First Received: July 4, 2007 Last Updated: July 5, 2007 History of Changes

Sponsored by:	University Hospital, Antwerp
Information provided by:	University Hospital, Antwerp
ClinicalTrials.gov Identifier:	NCT00497211

Purpose

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.

Condition	Intervention	Phase
Myocardial Infarction	Procedure: Intracoronary mononuclear cell infusion	Phase II Phase III

MedlinePlus related topics: Heart Attack

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Non-Randomized, Open Label, Placebo Control, Parallel Assignment, Safety/Efficacy Study

Eligibility

Ages Eligible for Study:	20 Years to 80 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00497211

Contacts

Contact: Steven E Haine, MD	0032.3.821.42.81	steven.haine@uza.be
Contact: Myriam Michiels, Nurse	0032.3.821.33.04	Myriam.michiels@uza.be

Locations

Belgium
Universitair Ziekenhuis Antwerpen	Recruiting
Edegem, Belgium, 2650
Sub-Investigator: Johan Bosmans, MD, PhD
Sub-Investigator: Marc Claeys, MD, PhD
Sub-Investigator: Hielko Miljoen, MD, PhD

Sponsors and Collaborators

University Hospital, Antwerp

Investigators

Principal Investigator:	Steven E Haine, MD	UZ Antwerpen
Study Director:	Chris Vrints, MD, PhD	UZ Antwerpen

More Information

No publications provided

Study ID Numbers:	EC 3/39/123
Study First Received:	July 4, 2007
Last Updated:	July 5, 2007
ClinicalTrials.gov Identifier:	NCT00497211 History of Changes
Health Authority:	Belgium: Institutional Review Board

Keywords provided by University Hospital, Antwerp:

First large acute myocardial infarction

Study placed in the following topic categories:

Necrosis
Heart Diseases
Myocardial Ischemia
Vascular Diseases

Ischemia
Infarction
Myocardial Infarction

Additional relevant MeSH terms:

Necrosis
Heart Diseases
Pathologic Processes
Myocardial Ischemia
Vascular Diseases

Cardiovascular Diseases
Ischemia
Infarction
Myocardial Infarction

ClinicalTrials.gov processed this record on May 07, 2009