Intracoronary Infusion of BM-Derived Mononuclear Cells in... | NCT00497211

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

NCT00497211

Sponsor

University Hospital, Antwerp

Status

Unknown status

Last Update Posted

Jul 6, 2007Estimated

Enrollment

Not provided

Phase

Phase 2Phase 3

Conditions

Myocardial Infarction

Interventions

Intracoronary mononuclear cell infusion

Countries

Belgium

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Jul 2007

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Not provided

Primary Completion Date

Not provided

Completion Date

Not provided

First Submitted Date

Jul 4, 2007

First Submission Date that Met QC Criteria

Jul 5, 2007

First Posted Date

Jul 6, 2007Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Jul 5, 2007

Last Update Posted Date

Jul 6, 2007Estimated

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Detailed Description

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 2Phase 3

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

Not provided

Name	Type	Description	Arm Group Labels	Other Names
Intracoronary mononuclear cell infusion	Procedure

Eligibility Module

Eligibility 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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

20 Years

Maximum Age

80 Years

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
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

Overall Officials

Name	Affiliation	Role
Steven E Haine, MD	UZ Antwerpen	Principal Investigator
Chris Vrints, MD, PhD	UZ Antwerpen	Study Director

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Universitair Ziekenhuis Antwerpen	Recruiting	Edegem		2650	Belgium

ID	Term
D017202	Myocardial Ischemia
D006331	Heart Diseases
D002318	Cardiovascular Diseases
D014652	Vascular Diseases