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

July 5, 2007 updated by: University Hospital, Antwerp
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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Study Type

Interventional

Phase

  • Phase 2
  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

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

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

20 years to 80 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Non-Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University Hospital, Antwerp

Investigators

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

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

First Submitted

July 4, 2007

First Submitted That Met QC Criteria

July 5, 2007

First Posted (Estimate)

July 6, 2007

Study Record Updates

Last Update Posted (Estimate)

July 6, 2007

Last Update Submitted That Met QC Criteria

July 5, 2007

Last Verified

July 1, 2007

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • EC 3/39/123

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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