Acute Anterior Wall Myocardial InfarctionPhase 2NCT00199823
Autologous Stem Cell Transplantation in Acute Myocardial Infarction
A Phase 2 study testing Intracoronary aotologous stem cell transplantation in people with Acute Anterior Wall Myocardial Infarction, run by Oslo University Hospital at 1 site in Norway.
Trial summary
Objectives Intracoronary transplantation of different cell populations have been used in acute myocardial infarction (AMI) with promising results. The primary objective of the ASTAMI study is to test whether intracoronary transplantation of autologous mononuclear bone marrow cells (mBMC) improve left ventricular… Read more about this study
- Who is it for?
- Ages 40 to 75 years
- Conditions the study is for
- Acute Anterior Wall Myocardial Infarction
- What is being tested?
- Intracoronary aotologous stem cell transplantation
- How many people
- 100 participants
- Where
- 1 siteNorway
- Study dates
- Sep 2003to May 2006
- Phase
- Phase 2
- 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 40 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- age 40-75 years
- anterior wall AMI with 120-720 minutes from onset of symptoms to PCI
- ST elevation on ECG according to WHO criteria
- angiographically significant stenosis on LAD proximal to the second diagonal branch
- successful PCI with stenting of culprit lesion
- hypokinetic, akinetic or dyskinetic segments assessed by echocardiography in a standard 16 segment model and
- CK-MB above 3 times upper reference value.
Who cannot join
- previous MI with established significant Q-waves on ECG
- cardiogenic shock
- permanent pacemaker or other contraindication to MRI
- stroke with significant sequela
- short life expectancy due to extra cardiac reason
- uncontrolled endocrinological disturbance
- HIV and/or HBV/HCV positive serology
- mental disorder or other condition which interferes with patient possibility to comply with the protocol.
Trial locations and contacts
1 site in 1 country.
About this study
Objectives
Intracoronary transplantation of different cell populations have been used in acute myocardial infarction (AMI) with promising results. The primary objective of the ASTAMI study is to test whether intracoronary transplantation of autologous mononuclear bone marrow cells (mBMC) improve left ventricular ejection fraction (LVEF) after anterior wall AMI.
Read more
Design
The ASTAMI study is a randomized, controlled, prospective study. One hundred patients with acute anterior wall ST-elevation myocardial infarction (STEMI) treated with acute PCI are randomized in a 1:1 way to either intracoronary transplantation of autologous mBMC 5-8 days after PCI or to control. Left ventricular function, exercise capacity, biochemical status, functional class, quality of life and complications are validated at baseline and during a 12-month follow up.
- Being tested
- Intracoronary aotologous stem cell transplantation
- Keywords
- Myocardial infarction, bone marrow cells, cell transplantation
- Medical subject headings
- Anterior Wall Myocardial Infarction, Myocardial Infarction
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Intracoronary aotologous stem cell transplantationGenetic
What is being measured
The primary outcome is the main question the study is designed to answer.
whether intracoronary mBMC transplantation improve LVEF after AMI assessed by ECG-gated SPECT.
Secondary outcomes (2)
To test whether mBMC treatment improve exercise capacity assessed by bicycle ergometry
To test whether mBMC treatment improve quality of life assessed by the SF 36 formula
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Sep 2005 (estimated)
- Study startSep 2003
- Study completionMay 2006
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 Anterior Wall Myocardial InfarctionStudies of the same condition, open and under way.
- More trials run by Oslo University HospitalThe sponsor's other registered studies.
- 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
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Enrolment
- 100 participants
Sponsor and investigators
- Lead sponsor
- Oslo University Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- University of Oslo, Ullevaal University Hospital
- Investigators
- Ketil Lunde, MD, Principal investigator, Oslo University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00199823
- Sponsor's protocol ID
- S-03115
- Status last verified
- Sep 2010
- First submitted
- 13 Sep 2005
- Last updated
- 6 Jul 2011
- Results posted
- No
Publications
Lunde K, Solheim S, Aakhus S, Arnesen H, Abdelnoor M, Egeland T, Endresen K, Ilebekk A, Mangschau A, Fjeld JG, Smith HJ, Taraldsrud E, Grogaard HK, Bjornerheim R, Brekke M, Muller C, Hopp E, Ragnarsson A, Brinchmann JE, Forfang K. Intracoronary injection of mononuclear bone marrow cells in acute myocardial infarction. N Engl J Med. 2006 Sep 21;355(12):1199-209. doi: 10.1056/NEJMoa055706.
PubMed 16990383Solheim S, Seljeflot I, Lunde K, Bratseth V, Aakhus S, Forfang K, Arnesen H. The influence of intracoronary injection of bone marrow cells on prothrombotic markers in patients with acute myocardial infarction. Thromb Res. 2012 Nov;130(5):765-8. doi: 10.1016/j.thromres.2011.11.045. Epub 2011 Dec 20.
PubMed 22192151Hopp E, Lunde K, Solheim S, Aakhus S, Arnesen H, Forfang K, Edvardsen T, Smith HJ. Regional myocardial function after intracoronary bone marrow cell injection in reperfused anterior wall infarction - a cardiovascular magnetic resonance tagging study. J Cardiovasc Magn Reson. 2011 Mar 17;13(1):22. doi: 10.1186/1532-429X-13-22.
PubMed 21414223
Study at a glance
From the registry record, last updated by the sponsor on 6 Jul 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Autologous Stem Cell Transplantation in Acute Myocardial Infarction
- ClinicalTrials.gov ID
- NCT00199823
- Acronym / sponsor ID
- S-03115
- Keywords
- Myocardial infarction, bone marrow cells, cell transplantation
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 100 participants
- Lead sponsor
- Oslo University HospitalUniversity, hospital or other
- Collaborators
- University of Oslo, Ullevaal University Hospital
- Study start
- Sep 2003
- Study completion
- May 2006
- First posted
- 20 Sep 2005 (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.
Objectives
Intracoronary transplantation of different cell populations have been used in acute myocardial infarction (AMI) with promising results. The primary objective of the ASTAMI study is to test whether intracoronary transplantation of autologous mononuclear bone marrow cells (mBMC) improve left ventricular ejection fraction (LVEF) after anterior wall AMI.
Design
The ASTAMI study is a randomized, controlled, prospective study. One hundred patients with acute anterior wall ST-elevation myocardial infarction (STEMI) treated with acute PCI are randomized in a 1:1 way to either intracoronary transplantation of autologous mBMC 5-8 days after PCI or to control. Left ventricular function, exercise capacity, biochemical status, functional class, quality of life and complications are validated at baseline and during a 12-month follow up.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
Who may qualify
- Ages
- 40 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- age 40-75 years
- anterior wall AMI with 120-720 minutes from onset of symptoms to PCI
- ST elevation on ECG according to WHO criteria
- angiographically significant stenosis on LAD proximal to the second diagonal branch
- successful PCI with stenting of culprit lesion
Key exclusion criteria (8 listed)
- previous MI with established significant Q-waves on ECG
- cardiogenic shock
- permanent pacemaker or other contraindication to MRI
- stroke with significant sequela
- short life expectancy due to extra cardiac reason
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 aotologous stem cell transplantation | Genetic | – |
Primary outcome
whether intracoronary mBMC transplantation improve LVEF after AMI assessed by ECG-gated SPECT.
2 secondary outcomes
To test whether mBMC treatment improve exercise capacity assessed by bicycle ergometry
To test whether mBMC treatment improve quality of life assessed by the SF 36 formula
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 6 Jul 2011.
- Results publication: PubMed 16990383Lunde K, Solheim S, Aakhus S, Arnesen H, Abdelnoor M, Egeland T, Endresen K, Ilebekk A, Mangschau A, Fjeld JG, Smith HJ, Taraldsrud E, Grogaard HK, Bjornerheim R, Brekke M, Muller C, Hopp E, Ragnarsson A, Brinchmann JE, Forfang K. Intracoronary injection of mononuclear bone marrow cells in acute myocardial infarction. N Engl J Med. 2006 Sep 21;355(12):1199-209. doi: 10.1056/NEJMoa055706.
- Derived from this study: PubMed 22192151Solheim S, Seljeflot I, Lunde K, Bratseth V, Aakhus S, Forfang K, Arnesen H. The influence of intracoronary injection of bone marrow cells on prothrombotic markers in patients with acute myocardial infarction. Thromb Res. 2012 Nov;130(5):765-8. doi: 10.1016/j.thromres.2011.11.045. Epub 2011 Dec 20.
- Derived from this study: PubMed 21414223Hopp E, Lunde K, Solheim S, Aakhus S, Arnesen H, Forfang K, Edvardsen T, Smith HJ. Regional myocardial function after intracoronary bone marrow cell injection in reperfused anterior wall infarction - a cardiovascular magnetic resonance tagging study. J Cardiovasc Magn Reson. 2011 Mar 17;13(1):22. doi: 10.1186/1532-429X-13-22.
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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.
Ketil Lunde, MD principal investigator
Oslo University Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Intracoronary aotologous stem cell transplantation in people with Acute Anterior Wall Myocardial Infarction, run by Oslo University Hospital at 1 site in Norway.
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 7 inclusion and 8 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 6 Jul 2011. 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 Norway. 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 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.
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?
whether intracoronary mBMC transplantation improve LVEF after AMI assessed by ECG-gated SPECT.. 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 NCT00199823, 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 6 Jul 2011; AzTrials last refreshed its copy on 8 Nov 2026.