NCT00316381

Brief Summary

The purpose of the study is to compare the efficiency of a sorted subpopulation of CD34+/CXCR4+ cells and unselected bone marrow-derived progenitor cells in the treatment of patients with acute myocardial infarction and a low left ventricular ejection fraction.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
200

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Nov 2004

Longer than P75 for not_applicable

Geographic Reach
1 country

4 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

November 1, 2004

Completed
1.5 years until next milestone

First Submitted

Initial submission to the registry

April 18, 2006

Completed
2 days until next milestone

First Posted

Study publicly available on registry

April 20, 2006

Completed
1.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2008

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2008

Completed
Last Updated

May 22, 2008

Status Verified

May 1, 2008

Enrollment Period

3.3 years

First QC Date

April 18, 2006

Last Update Submit

May 20, 2008

Conditions

Myocardial Infarction

Keywords

stem cellsacute myocardial infarctionregenerationleft ventricular ejection fraction

Outcome Measures

Primary Outcomes (2)

  • Left ventricular ejection fraction and volumes measured by echocardiography

    6 months

  • Left ventricular ejection fraction and volumes measured by angiography

    6 months

Secondary Outcomes (3)

  • Safety

    6, 12 months

  • Left ventricular function in dobutamine stress test

    6 months

  • Coronary flow reserve by adenosine MRI test

    6 months

Interventions

Autologous bone marrow-derived stem cellsPROCEDURE

Eligibility Criteria

Age18 Years - 75 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Acute myocardial infarction treated successfully with primary coronary angioplasty
  • Left ventricular ejection fraction less than 40%
  • Informed consent granted

You may not qualify if:

  • Presence of significant coronary stenoses in non-infarct related artery requiring revascularization
  • Cardiogenic shock
  • Previous myocardial infarction
  • Age \< 18 years and \> 75 years
  • Pregnancy
  • Neoplasm
  • Contraindications for MRI

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (4)

III Division of Cardiology Silesian School of Medicine

Katowice, 40-653, Poland

Location

Jagiellonian University Institute of Cardiology

Krakow, 31-202, Poland

Location

Poznan University of Medical Sciences II Clinic of Cardiology

Poznan, 61-701, Poland

Location

National Institute of Cardiology

Warsaw, 04-628, Poland

Location

Related Publications (4)

  • Wojakowski W, Tendera M, Michalowska A, Majka M, Kucia M, Maslankiewicz K, Wyderka R, Ochala A, Ratajczak MZ. Mobilization of CD34/CXCR4+, CD34/CD117+, c-met+ stem cells, and mononuclear cells expressing early cardiac, muscle, and endothelial markers into peripheral blood in patients with acute myocardial infarction. Circulation. 2004 Nov 16;110(20):3213-20. doi: 10.1161/01.CIR.0000147609.39780.02. Epub 2004 Nov 8.

    PMID: 15533859BACKGROUND

  • Wojakowski W, Tendera M, Zebzda A, Michalowska A, Majka M, Kucia M, Maslankiewicz K, Wyderka R, Krol M, Ochala A, Kozakiewicz K, Ratajczak MZ. Mobilization of CD34(+), CD117(+), CXCR4(+), c-met(+) stem cells is correlated with left ventricular ejection fraction and plasma NT-proBNP levels in patients with acute myocardial infarction. Eur Heart J. 2006 Feb;27(3):283-9. doi: 10.1093/eurheartj/ehi628. Epub 2005 Nov 2.

    PMID: 16267071BACKGROUND

  • Kucia M, Ratajczak J, Ratajczak MZ. Bone marrow as a source of circulating CXCR4+ tissue-committed stem cells. Biol Cell. 2005 Feb;97(2):133-46. doi: 10.1042/BC20040069.

    PMID: 15656779BACKGROUND

  • Dabrowski W, Tekieli L, Mazurek A, Lanocha M, Banys RP, Zmudka K, Majka M, Wojakowski W, Tendera M, Musialek P. Transcoronary stem cell transfer and evolution of infarct-related artery atherosclerosis: evaluation with conventional and novel imaging techniques including Quantitative Virtual Histology (qVH). Postepy Kardiol Interwencyjnej. 2022 Dec;18(4):483-495. doi: 10.5114/aic.2023.125609. Epub 2023 Feb 6.

    PMID: 36967840DERIVED

MeSH Terms

Conditions

Myocardial Infarction

Condition Hierarchy (Ancestors)

Myocardial IschemiaHeart DiseasesCardiovascular DiseasesVascular DiseasesInfarctionIschemiaPathologic ProcessesPathological Conditions, Signs and SymptomsNecrosis

Study Officials

  • Michal Tendera, MD, PhD

    Third Division of Cardiology Silesian School of Medicine

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER

Study Record Dates

First Submitted

April 18, 2006

First Posted

April 20, 2006

Study Start

November 1, 2004

Primary Completion

March 1, 2008

Study Completion

March 1, 2008

Last Updated

May 22, 2008

Record last verified: 2008-05

Locations

PL(4)