Back to resultsBone Marrow Cells in Myocardial Infarction
Primary Purpose
Acute Myocardial Infarction
Status
Completed
Phase
Phase 2
Locations
Finland
Study Type
Interventional
Intervention
intracoronary injection of bone marrow cells
Sponsored by
About this trial
This is an interventional treatment trial for Acute Myocardial Infarction focused on measuring stem cell, acute myocardial infarction
Eligibility Criteria
Inclusion Criteria: Acute ST-elevation myocardial infarction treated with thrombolytic therapy Exclusion Criteria: Indication for rescue PCI, severe clinical heart failure, age <18 years
Sites / Locations
- University of Oulu
Outcomes
Primary Outcome Measures
Arrhythmia risk variables
left ventricular function
restenosis assessed by IVUS
Secondary Outcome Measures
exercise tolerance
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT00363324
Brief Title
Bone Marrow Cells in Myocardial Infarction
Official Title
Effects of Autologous Bone Marrow Celss on Acute ST-Elevation Myocardial Infarction
Study Type
Interventional
2. Study Status
Record Verification Date
December 2007
Overall Recruitment Status
Completed
Study Start Date
January 2005 (undefined)
Primary Completion Date
November 2007 (Actual)
Study Completion Date
November 2007 (Actual)
3. Sponsor/Collaborators
Name of the Sponsor
University of Oulu
4. Oversight
5. Study Description
Brief Summary
This study is aimed to assess the effect of bone marrow cells on arrhythmia risk variables in patients with a acute myocardial infarction.
Detailed Description
This is a randomized, double-blinded study, where patients treated with thrombolytic therapy for acute myocardial infarction are randomized to receive bone-marrow derived stem cells or sham-infusion at the time percutaneous coronary intervention of the target vessel. The end-points are many arrhythmia risk variables, suchs as heart rate variability, T-wave alternans and many ECG variables as well as systolic and diastolic left ventricular function.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Acute Myocardial Infarction
Keywords
stem cell, acute myocardial infarction
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2, Phase 3
Interventional Study Model
Parallel Assignment
Masking
Double
Allocation
Randomized
Enrollment
100 (Anticipated)
8. Arms, Groups, and Interventions
Intervention Type
Procedure
Intervention Name(s)
intracoronary injection of bone marrow cells
Primary Outcome Measure Information:
Title
Arrhythmia risk variables
Title
left ventricular function
Title
restenosis assessed by IVUS
Secondary Outcome Measure Information:
Title
exercise tolerance
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Acute ST-elevation myocardial infarction treated with thrombolytic therapy
Exclusion Criteria:
Indication for rescue PCI, severe clinical heart failure, age <18 years
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Heikki V Huikuri, Professor
Organizational Affiliation
University of Oulu
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Oulu
City
Oulu
ZIP/Postal Code
90220
Country
Finland
12. IPD Sharing Statement
Citations:
PubMed Identifier
20961630
Citation
Miettinen JA, Salonen RJ, Niemela M, Kervinen K, Saily M, Koistinen P, Savolainen ER, Ukkonen H, Pietila M, Airaksinen KE, Knuuti J, Makikallio TH, Huikuri HV, Ylitalo KV. Effects of intracoronary infusion of bone marrow-derived stem cells on pulmonary artery pressure and diastolic function after myocardial infarction. Int J Cardiol. 2010 Dec 3;145(3):631-3. doi: 10.1016/j.ijcard.2010.09.064. Epub 2010 Oct 20. No abstract available.
Results Reference
derived
PubMed Identifier
19910293
Citation
Miettinen JA, Ylitalo K, Hedberg P, Jokelainen J, Kervinen K, Niemela M, Saily M, Koistinen P, Savolainen ER, Ukkonen H, Pietila M, Airaksinen KE, Knuuti J, Vuolteenaho O, Makikallio TH, Huikuri HV. Determinants of functional recovery after myocardial infarction of patients treated with bone marrow-derived stem cells after thrombolytic therapy. Heart. 2010 Mar;96(5):362-7. doi: 10.1136/hrt.2009.171694. Epub 2009 Nov 11.
Results Reference
derived
PubMed Identifier
18845667
Citation
Huikuri HV, Kervinen K, Niemela M, Ylitalo K, Saily M, Koistinen P, Savolainen ER, Ukkonen H, Pietila M, Airaksinen JK, Knuuti J, Makikallio TH; FINCELL Investigators. Effects of intracoronary injection of mononuclear bone marrow cells on left ventricular function, arrhythmia risk profile, and restenosis after thrombolytic therapy of acute myocardial infarction. Eur Heart J. 2008 Nov;29(22):2723-32. doi: 10.1093/eurheartj/ehn436. Epub 2008 Oct 9.
Results Reference
derived
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Bone Marrow Cells in Myocardial Infarction
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