NCT00363324

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.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
100

participants targeted

Target at P50-P75 for phase_2

Timeline
Completed

Started Jan 2005

Typical duration for phase_2

Geographic Reach
1 country

1 active site

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

January 1, 2005

Completed
1.6 years until next milestone

First Submitted

Initial submission to the registry

August 10, 2006

Completed
5 days until next milestone

First Posted

Study publicly available on registry

August 15, 2006

Completed
1.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2007

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2007

Completed
Last Updated

January 9, 2008

Status Verified

December 1, 2007

Enrollment Period

2.8 years

First QC Date

August 10, 2006

Last Update Submit

December 27, 2007

Conditions

Keywords

stem cellacute myocardial infarction

Outcome Measures

Primary Outcomes (3)

  • Arrhythmia risk variables

  • left ventricular function

  • restenosis assessed by IVUS

Secondary Outcomes (1)

  • exercise tolerance

Interventions

Eligibility Criteria

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

You may qualify if:

  • Acute ST-elevation myocardial infarction treated with thrombolytic therapy

You may not qualify if:

  • Indication for rescue PCI, severe clinical heart failure, age \<18 years

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Oulu

Oulu, 90220, Finland

Location

Related Publications (3)

  • 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.

  • 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.

  • 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.

Study Officials

  • Heikki V Huikuri, Professor

    University of Oulu

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
DOUBLE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER

Study Record Dates

First Submitted

August 10, 2006

First Posted

August 15, 2006

Study Start

January 1, 2005

Primary Completion

November 1, 2007

Study Completion

November 1, 2007

Last Updated

January 9, 2008

Record last verified: 2007-12

Locations