Acute Myocardial InfarctionPhase 2NCT00135928
Stem Cells in Myocardial Infarction
A Phase 2 study testing Granulocyte Colony Stimulating Factor G-CSF (Neupogen®) in people with Acute Myocardial Infarction, run by Copenhagen University Hospital, Rigshospitalet at 1 site in Denmark.
Trial summary
The purpose of this trial is to investigate the effect of treatment with granulocyte-colony stimulating factor (G-CSF) bone marrow stimulation on circulating stem cells' ability to develop new blood vessels in the myocardium after an acute myocardial infarction. Read more about this study
- Who is it for?
- Ages 20 to 70 years
- Conditions the study is for
- Acute Myocardial Infarction
- What is being tested?
- Granulocyte Colony Stimulating Factor G-CSF (Neupogen®)
- How many people
- 78 participants
- Where
- 1 siteDenmark
- Study dates
- May 2003to Feb 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 20 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients between 20 and 70 years with STEMI were eligible if they had a successful PCI within 12 hours after onset of symptoms.
- The target lesion had to be located in the proximal section of the left anterior descending (LAD), left circumflex (LCX) or right coronary artery (RCA).
- Only patients with creatine kinase [CK]-MB >100 microgram/L or development of Q waves in the electrocardiogram were included.
Who cannot join
- Ventricular arrhythmia after PCI requiring treatment
- Pregnancy
- Unprotected left main stem lesion
- History of prior myocardial infarction
- Diagnosed or suspected cancer
- New York Heart Association (NYHA) class 3-4
- Known severe claustrophobia
- Significant stenosis in another coronary vessel than the acutely treated vessel, that might demand treatment with PCI or coronary artery bypass graft surgery (CABG) prior to the last follow-up exam.
Trial locations and contacts
1 site in 1 country.
Denmark1 site
2014 Department of Cardiology, The Heart Centre, University Hospital Rigshospitalet
Copenhagen, 2100
About this study
Official title: Bone Marrow Stimulation With G-CSF in Acute Myocardial Infarction,
The purpose of this trial is to investigate the effect of treatment with granulocyte-colony stimulating factor (G-CSF) bone marrow stimulation on circulating stem cells' ability to develop new blood vessels in the myocardium after an acute myocardial infarction.
Read the detailed description
Intracoronary infusion of bone-marrow stem cells after a ST elevation myocardial infarction (STEMI) seems to improve cardiac function. An alternative strategy is increase of circulating stem cells by mobilisation from the bone marrow with Granulocyte-Colony Stimulating Factor (G-CSF).
Objective: To determine the short-term (30 days) safety of G-CSF therapy after a STEMI treated with acute percutaneous coronary intervention (PCI).
Methods: Patients with STEMI treated with PCI <12 hours after symptom onset were randomised (1:1) to G-CSF (10 μg/kg/d) or placebo for 6 days in a double-blind design. Other inclusion criteria: age 20-70 years, culprit lesion in a large coronary artery, and peak CKMB >100 microgram/L. Follow-up was done after 1, 5 and 6 months, with an angiogram at 5 months.
- Conditions
- Acute Myocardial Infarction
- Being tested
- Granulocyte Colony Stimulating Factor G-CSF (Neupogen®)
- Keywords
- ST-elevation myocardial infarction, granulocyte-colony stimulating factor angiogenesis, stem cells
- Medical subject headings
- ST Elevation Myocardial Infarction
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Granulocyte Colony Stimulating Factor G-CSF (Neupogen®)Drug
What is being measured
The primary outcome is the main question the study is designed to answer.
The pre-specified primary endpoint is change in regional systolic wall thickening from day 1 to day 180 evaluated with cardiac magnetic resonance imaging (MRI)
Secondary outcomes (2)
Change in ejection fraction, end-systolic and end-diastolic volumes, regional myocardial perfusion, and infarct size by MRI
Change in regional myocardial function by tissue Doppler echocardiography
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Aug 2005 (estimated)
- Study startMay 2003
- Primary completionFeb 2006
- Study completionFeb 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 Myocardial InfarctionStudies of the same condition, open and under way.
- More trials run by Copenhagen University Hospital, RigshospitaletThe 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
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Enrolment
- 78 participants
Sponsor and investigators
- Lead sponsor
- Copenhagen University Hospital, Rigshospitalet
- Sponsor type
- University, hospital or other
- Investigators
- Jens Kastrup, MD DMSc, Principal investigator, 2014 Department of Cardiology, The Heart Centre, University Hospital Rigshospitalet, DK-2100 Copenhagen, Denmark.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00135928
- Sponsor's protocol ID
- STEMMI
- Status last verified
- Feb 2005
- First submitted
- 25 Aug 2005
- Last updated
- 8 Aug 2011
- Results posted
- No
Publications
Ripa RS, Jorgensen E, Kastrup J. Clinical outcome after stem cell mobilization with granulocyte-colony-stimulating factor after acute ST-elevation myocardial infarction: 5-year results of the STEMMI trial. Scand J Clin Lab Invest. 2013 Mar;73(2):125-9. doi: 10.3109/00365513.2012.750010. Epub 2013 Jan 3.
PubMed 23281844Hedegaard A, Ripa RS, Johansen JS, Jorgensen E, Kastrup J. Plasma YKL-40 and recovery of left ventricular function after acute myocardial infarction. Scand J Clin Lab Invest. 2010 Apr;70(2):80-6. doi: 10.3109/00365510903518191.
PubMed 20102300Overgaard M, Ripa RS, Wang Y, Jorgensen E, Kastrup J. Timing of granulocyte-colony stimulating factor treatment after acute myocardial infarction and recovery of left ventricular function: results from the STEMMI trial. Int J Cardiol. 2010 Apr 30;140(3):351-5. doi: 10.1016/j.ijcard.2008.11.120. Epub 2009 Jan 7.
PubMed 19131132
Study at a glance
From the registry record, last updated by the sponsor on 8 Aug 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Bone Marrow Stimulation With G-CSF in Acute Myocardial Infarction,
- ClinicalTrials.gov ID
- NCT00135928
- Acronym / sponsor ID
- STEMMI
- Conditions
- Acute Myocardial Infarction
- Keywords
- ST-elevation myocardial infarction, granulocyte-colony stimulating factor angiogenesis, stem cells
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 78 participants
- Lead sponsor
- Copenhagen University Hospital, RigshospitaletUniversity, hospital or other
- Study start
- May 2003
- Primary completion
- Feb 2006 (actual)
- Study completion
- Feb 2006 (actual)
- First posted
- 26 Aug 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.
The purpose of this trial is to investigate the effect of treatment with granulocyte-colony stimulating factor (G-CSF) bone marrow stimulation on circulating stem cells' ability to develop new blood vessels in the myocardium after an acute myocardial infarction.
Detailed description
Intracoronary infusion of bone-marrow stem cells after a ST elevation myocardial infarction (STEMI) seems to improve cardiac function. An alternative strategy is increase of circulating stem cells by mobilisation from the bone marrow with Granulocyte-Colony Stimulating Factor (G-CSF).
Objective: To determine the short-term (30 days) safety of G-CSF therapy after a STEMI treated with acute percutaneous coronary intervention (PCI).
Methods: Patients with STEMI treated with PCI <12 hours after symptom onset were randomised (1:1) to G-CSF (10 μg/kg/d) or placebo for 6 days in a double-blind design. Other inclusion criteria: age 20-70 years, culprit lesion in a large coronary artery, and peak CKMB >100 microgram/L. Follow-up was done after 1, 5 and 6 months, with an angiogram at 5 months.
Study design
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
Who may qualify
- Ages
- 20 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Patients between 20 and 70 years with STEMI were eligible if they had a successful PCI within 12 hours after onset of symptoms.
- The target lesion had to be located in the proximal section of the left anterior descending (LAD), left circumflex (LCX) or right coronary artery (RCA).
- Only patients with creatine kinase [CK]-MB >100 microgram/L or development of Q waves in the electrocardiogram were included.
Key exclusion criteria (8 listed)
- Ventricular arrhythmia after PCI requiring treatment
- Pregnancy
- Unprotected left main stem lesion
- History of prior myocardial infarction
- Diagnosed or suspected cancer
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 |
|---|---|---|
| Granulocyte Colony Stimulating Factor G-CSF (Neupogen®) | Drug | – |
Primary outcome
The pre-specified primary endpoint is change in regional systolic wall thickening from day 1 to day 180 evaluated with cardiac magnetic resonance imaging (MRI)
2 secondary outcomes
Change in ejection fraction, end-systolic and end-diastolic volumes, regional myocardial perfusion, and infarct size by MRI
Change in regional myocardial function by tissue Doppler echocardiography
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 8 Aug 2011.
- Derived from this study: PubMed 23281844Ripa RS, Jorgensen E, Kastrup J. Clinical outcome after stem cell mobilization with granulocyte-colony-stimulating factor after acute ST-elevation myocardial infarction: 5-year results of the STEMMI trial. Scand J Clin Lab Invest. 2013 Mar;73(2):125-9. doi: 10.3109/00365513.2012.750010. Epub 2013 Jan 3.
- Derived from this study: PubMed 20102300Hedegaard A, Ripa RS, Johansen JS, Jorgensen E, Kastrup J. Plasma YKL-40 and recovery of left ventricular function after acute myocardial infarction. Scand J Clin Lab Invest. 2010 Apr;70(2):80-6. doi: 10.3109/00365510903518191.
- Derived from this study: PubMed 19131132Overgaard M, Ripa RS, Wang Y, Jorgensen E, Kastrup J. Timing of granulocyte-colony stimulating factor treatment after acute myocardial infarction and recovery of left ventricular function: results from the STEMMI trial. Int J Cardiol. 2010 Apr 30;140(3):351-5. doi: 10.1016/j.ijcard.2008.11.120. Epub 2009 Jan 7.
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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.
Jens Kastrup, MD DMSc principal investigator
2014 Department of Cardiology, The Heart Centre, University Hospital Rigshospitalet, DK-2100 Copenhagen, Denmark.
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 Granulocyte Colony Stimulating Factor G-CSF (Neupogen®) in people with Acute Myocardial Infarction, run by Copenhagen University Hospital, Rigshospitalet at 1 site in Denmark.
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 3 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 8 Aug 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 Denmark. 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?
The pre-specified primary endpoint is change in regional systolic wall thickening from day 1 to day 180 evaluated with cardiac magnetic resonance imaging (MRI). 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 NCT00135928, 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 8 Aug 2011.