Acute Myocardial InfarctionPhase 2/3NCT00363324
Bone Marrow Cells in Myocardial Infarction
A Phase 2/3 study testing intracoronary injection of bone marrow cells in people with Acute Myocardial Infarction, run by University of Oulu at 1 site in Finland.
Trial summary
This study is aimed to assess the effect of bone marrow cells on arrhythmia risk variables in patients with a acute myocardial infarction. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Acute Myocardial Infarction
- What is being tested?
- intracoronary injection of bone marrow cells
- Type of treatment
- Injection or infusion, Surgery or procedure
- How many people
- 100 participants
- Where
- 1 siteFinland
- Study dates
- Jan 2005to Nov 2007
- Phase
- Phase 2/3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Acute ST-elevation myocardial infarction treated with thrombolytic therapy
Who cannot join
- Indication for rescue PCI, severe clinical heart failure, age <18 years
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effects of Autologous Bone Marrow Celss on Acute ST-Elevation Myocardial Infarction
This study is aimed to assess the effect of bone marrow cells on arrhythmia risk variables in patients with a acute myocardial infarction.
Read the 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.
- Conditions
- Acute Myocardial Infarction
- Being tested
- intracoronary injection of bone marrow cells
- Keywords
- stem cell, acute myocardial infarction
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
intracoronary injection of bone marrow cellsProcedure or surgery
What is being measured
The primary outcome is the main question the study is designed to answer.
Arrhythmia risk variables
left ventricular function
restenosis assessed by IVUS
Secondary outcomes (1)
exercise tolerance
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Aug 2006 (estimated)
- Study startJan 2005
- Primary completionNov 2007
- Study completionNov 2007
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Acute Myocardial InfarctionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2/3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Oulu
- Sponsor type
- University, hospital or other
- Investigators
- Heikki V Huikuri, Professor, Principal investigator, University of Oulu
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00363324
- Sponsor's protocol ID
- 82/04
- Status last verified
- Dec 2007
- First submitted
- 10 Aug 2006
- Last updated
- 9 Jan 2008
- Results posted
- No
Publications
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.
PubMed 20961630Miettinen 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.
PubMed 19910293Huikuri 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.
PubMed 18845667
Study at a glance
From the registry record, last updated by the sponsor on 9 Jan 2008. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Autologous Bone Marrow Celss on Acute ST-Elevation Myocardial Infarction
- ClinicalTrials.gov ID
- NCT00363324
- Acronym / sponsor ID
- 82/04
- Conditions
- Acute Myocardial Infarction
- Keywords
- stem cell, acute myocardial infarction
- Phase
- Phase 2/3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- University of OuluUniversity, hospital or other
- Study start
- Jan 2005
- Primary completion
- Nov 2007 (actual)
- Study completion
- Nov 2007 (actual)
- First posted
- 15 Aug 2006 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Acute ST-elevation myocardial infarction treated with thrombolytic therapy
Key exclusion criteria (1 listed)
- Indication for rescue PCI, severe clinical heart failure, age <18 years
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| intracoronary injection of bone marrow cells | Procedure or surgery | – |
Primary outcome
Arrhythmia risk variables
left ventricular function
restenosis assessed by IVUS
1 secondary outcome
exercise tolerance
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Jan 2008.
- Derived from this study: PubMed 20961630Miettinen 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.
- Derived from this study: PubMed 19910293Miettinen 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.
- Derived from this study: PubMed 18845667Huikuri 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Heikki V Huikuri, Professor principal investigator
University of Oulu
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2/3 study testing intracoronary injection of bone marrow cells in people with Acute Myocardial Infarction, run by University of Oulu at 1 site in Finland.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 9 Jan 2008. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Finland. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Arrhythmia risk variables. The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00363324, which also lists 3 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Jan 2008.