Bone Marrow Cells in Myocardial Infarction

NCT ID: NCT00363324

Last Updated: 2008-01-09

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

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2/PHASE3

Total Enrollment

100 participants

Study Classification

INTERVENTIONAL

Study Start Date

2005-01-31

Study Completion Date

2007-11-30

Brief Summary

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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

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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.

Conditions

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Acute Myocardial Infarction

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Interventions

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intracoronary injection of bone marrow cells

Intervention Type PROCEDURE

Eligibility Criteria

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Inclusion Criteria

* Acute ST-elevation myocardial infarction treated with thrombolytic therapy

Exclusion Criteria

* Indication for rescue PCI, severe clinical heart failure, age \<18 years
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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University of Oulu

OTHER

Sponsor Role lead

Principal Investigators

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Heikki V Huikuri, Professor

Role: PRINCIPAL_INVESTIGATOR

University of Oulu

Locations

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University of Oulu

Oulu, , Finland

Site Status

Countries

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Finland

References

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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.

Reference Type DERIVED
PMID: 20961630 (View on PubMed)

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.

Reference Type DERIVED
PMID: 19910293 (View on PubMed)

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.

Reference Type DERIVED
PMID: 18845667 (View on PubMed)

Other Identifiers

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82/04

Identifier Type: -

Identifier Source: org_study_id

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