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

NCT00497211 | Unknown Phase 2

• 1 other identifier: EC 3/39/123
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

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.

Conditions

Myocardial Infarction

Keywords

First large acute myocardial infarction

Interventions

Intracoronary mononuclear cell infusion PROCEDURE

Eligibility Criteria

• Age: 20 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University Hospital, Antwerp: lead

Study Sites (1)

Universitair Ziekenhuis Antwerpen

Edegem, 2650, Belgium

RECRUITING

MeSH Terms

Conditions

Myocardial Infarction

Condition Hierarchy (Ancestors)

Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Vascular Diseases; Infarction; Ischemia; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Necrosis

Study Officials

• Steven E Haine, MD

  UZ Antwerpen

  PRINCIPAL INVESTIGATOR

• Chris Vrints, MD, PhD

  UZ Antwerpen

  STUDY DIRECTOR

Central Study Contacts

Steven E Haine, MD

CONTACT

0032.3.821.42.81; steven.haine@uza.be

Myriam Michiels, Nurse

CONTACT

0032.3.821.33.04; Myriam.michiels@uza.be

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: July 4, 2007
• First Posted: July 6, 2007
• Last Updated: July 6, 2007

Record last verified: 2007-07

Locations

BE (1)