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

The recruitment status of this study is unknown. The completion date has passed and the status has not been verified in more than two years.
Verified July 2007 by University Hospital, Antwerp.
Recruitment status was:  Recruiting
Sponsor:
ClinicalTrials.gov Identifier:
NCT00497211
First Posted: July 6, 2007
Last Update Posted: July 6, 2007
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by:
University Hospital, Antwerp
  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 2 Phase 3

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment

Resource links provided by NLM:


Further study details as provided by University Hospital, Antwerp:

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   20 Years to 80 Years   (Adult, Senior)
Sexes Eligible for Study:   All
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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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

ClinicalTrials.gov Identifier: NCT00497211     History of Changes
Other Study ID Numbers: EC 3/39/123
First Submitted: July 4, 2007
First Posted: July 6, 2007
Last Update Posted: July 6, 2007
Last Verified: July 2007

Keywords provided by University Hospital, Antwerp:
First large acute myocardial infarction

Additional relevant MeSH terms:
Infarction
Myocardial Infarction
Ischemia
Pathologic Processes
Necrosis
Myocardial Ischemia
Heart Diseases
Cardiovascular Diseases
Vascular Diseases