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

Myocardial Infarction Clinical Trial

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT00497211
• Other study ID #: EC 3/39/123
• Status: Recruiting
• Phase: Phase 2/Phase 3
• First received: July 4, 2007
• Last updated: July 5, 2007

Study information

• Verified date: July 2007
• Source: University Hospital, Antwerp
• Contact: Steven E Haine, MD
• Phone: 0032.3.821.42.81
• Email: steven.haine[@]uza.be
• Is FDA regulated: No
• Health authority: Belgium: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 0
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 20 Years to 80 Years

Eligibility

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 Design

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Infarction
• Myocardial Infarction

Intervention

Procedure:
• Intracoronary mononuclear cell infusion

Locations

Country	Name	City	State
Belgium	Universitair Ziekenhuis Antwerpen	Edegem

Sponsors (1)

Lead Sponsor	Collaborator
University Hospital, Antwerp

Country where clinical trial is conducted

Belgium,