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

NCT ID: NCT00497211

Last Updated: 2007-07-06

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

UNKNOWN

Clinical Phase

PHASE2/PHASE3

Study Classification

INTERVENTIONAL

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Myocardial Infarction

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

NON_RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Intracoronary mononuclear cell infusion

Intervention Type PROCEDURE

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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
Minimum Eligible Age

20 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

University Hospital, Antwerp

OTHER

Sponsor Role lead

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Steven E Haine, MD

Role: PRINCIPAL_INVESTIGATOR

UZ Antwerpen

Chris Vrints, MD, PhD

Role: STUDY_DIRECTOR

UZ Antwerpen

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Universitair Ziekenhuis Antwerpen

Edegem, , Belgium

Site Status RECRUITING

Countries

Review the countries where the study has at least one active or historical site.

Belgium

Central Contacts

Reach out to these primary contacts for questions about participation or study logistics.

Steven E Haine, MD

Role: CONTACT

0032.3.821.42.81

Myriam Michiels, Nurse

Role: CONTACT

0032.3.821.33.04

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

EC 3/39/123

Identifier Type: -

Identifier Source: org_study_id