Acute Myocardial InfarctionPhase 2SCAMINCT00669227
Intracoronary Stem Cell Therapy in Patients With Acute Myocardial Infarction (SCAMI)
A Phase 2 study testing autologous stem cells in people with Acute Myocardial Infarction and Coronary Artery Disease, run by University of Ulm at 1 site in Germany.
Trial summary
Autologous stem cells may improve myocardial regeneration after intracoronary administration in patients with acute myocardial infarction. The primary hypothesis of this prospective, placebo-controlled, double-blind trial is that the increase of ejection fraction determined by magnetic resonance imaging between… Read more about this study
- Who is it for?
- Ages 35 to 75 years
- Conditions the study is for
- Acute Myocardial Infarction, Coronary Artery Disease
- What is being tested?
- autologous stem cells
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 42 participants
- Where
- 1 siteGermany
- Study dates
- Oct 2005to Jan 2009
- 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 35 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- acute myocardial infarction with time to revascularization >6 hours from symptom start
- clear target vessel
- large myocardial infarction defined as: proximal vessel occlusion, CK > 1000 U/L, myocardial scar in magnetic resonance imaging > 10% of left ventricular muscle mass
- potential prior thrombolysis
- written informed consent
Who cannot join
- acute myocardial infarction with revascularization within 6 hours after symptom start
- prior myocardial infarction
- no clear target vessel
- contraindication for magnetic resonance imaging (e.g. pacemaker, ICD)
- severely depressed left ventricular ejection fraction (less than 20% in magnetic resonance imaging)
- prior hematologic disease
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- prior chemo therapy
- prior stem cell transplantation
- prior treatment with G-CSF
- known alteration of the bone marrow by alcohol or drugs, e.g. agranulocytosis
- local infection of puncture sites
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Intracoronary Stem Cell Therapy in Patients With Acute Myocardial Infarction - A Randomized, Double-blind, Placebo Controlled Trial (SCAMI)
Autologous stem cells may improve myocardial regeneration after intracoronary administration in patients with acute myocardial infarction. The primary hypothesis of this prospective, placebo-controlled, double-blind trial is that the increase of ejection fraction determined by magnetic resonance imaging between baseline and 6 months follow-up is superior in active treated patients compared to patients receiving placebo. The study includes an integrated pilot phase of 40 patients for evaluation of left ventricular ejection fraction determined by cardiac magnetic resonance imaging. Based on the data of this analysis the final sample size will be calculated. The primary endpoint is the improvement in left ventricular ejection fraction with an assumed 2.5% higher improvement in the cell treated population compared to the placebo treated group.
Read the detailed description
There is a 2:1 randomization for bone marrow cell therapy versus placebo therapy. Patients will be stratified according to age, localization of myocardial infarction and left ventricular function.
- Being tested
- autologous stem cells, placebo suspension
- Medical subject headings
- Coronary Artery Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
autologous stem cellsOther
intracoronary administration at the same day of cell aspiration using the stop flow technique
placebo suspensionOther
intracoronary administration at the same day as cell aspiration
| Study group | Role | What they receive |
|---|---|---|
| 1 | Active comparator | autologous stem cells, Ficoll preparation, intracoronary administration at the same day of bone marrow cell aspiration Receives: Other: autologous stem cells |
| 2 | Placebo comparator | placebo is visually indistinguishable from verum due to integration of autologous erythrocytes, intracoronary administration the same day of bone marrow aspiration Receives: Other: placebo suspension |
What is being measured
The primary outcome is the main question the study is designed to answer.
difference in left ventricular ejection fraction measured by magnetic resonance imaging at baseline and 6 months follow-up
Measured: 6 months
Secondary outcomes (4)
left ventricular ejection fraction measured by magnetic resonance imaging
Measured: 1, 3, 12 months
left ventricular enddiastolic volume measured by magnetic resonance imaging
Measured: 1, 3, 6, 12 months
left ventricular endsystolic volume measured by magnetic resonance imaging
Measured: 1, 3, 6, 12 months
major adverse cardiac events
Measured: 1, 3, 6, 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Apr 2008 (estimated)
- Study startOct 2005
- Primary completionJan 2009
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)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
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 42 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Ulm
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Jochen Wohrle, University of Ulm
- Investigators
- Jochen Wöhrle, MD; FESC, Principal investigator, University of Ulm
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00669227
- Sponsor's protocol ID
- SCAMI 01-04
- Acronym
- SCAMI
- Status last verified
- Jun 2014
- First submitted
- 28 Apr 2008
- Last updated
- 10 Jun 2014
- Results posted
- No
- Data monitoring committee
- No
Publications
Wohrle J, Merkle N, Mailander V, Nusser T, Schauwecker P, von Scheidt F, Schwarz K, Bommer M, Wiesneth M, Schrezenmeier H, Hombach V. Results of intracoronary stem cell therapy after acute myocardial infarction. Am J Cardiol. 2010 Mar 15;105(6):804-12. doi: 10.1016/j.amjcard.2009.10.060.
PubMed 20211323Wohrle J, von Scheidt F, Schauwecker P, Wiesneth M, Markovic S, Schrezenmeier H, Hombach V, Rottbauer W, Bernhardt P. Impact of cell number and microvascular obstruction in patients with bone-marrow derived cell therapy: final results from the randomized, double-blind, placebo controlled intracoronary Stem Cell therapy in patients with Acute Myocardial Infarction (SCAMI) trial. Clin Res Cardiol. 2013 Oct;102(10):765-70. doi: 10.1007/s00392-013-0595-9. Epub 2013 Jul 30.
PubMed 23896972
Study at a glance
From the registry record, last updated by the sponsor on 10 Jun 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Intracoronary Stem Cell Therapy in Patients With Acute Myocardial Infarction - A Randomized, Double-blind, Placebo Controlled Trial (SCAMI)
- ClinicalTrials.gov ID
- NCT00669227
- Acronym / sponsor ID
- SCAMI / SCAMI 01-04
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 42 participants (actual)
- Lead sponsor
- University of UlmUniversity, hospital or other
- Study start
- Oct 2005
- Primary completion
- Jan 2009 (actual)
- First posted
- 30 Apr 2008 (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.
Autologous stem cells may improve myocardial regeneration after intracoronary administration in patients with acute myocardial infarction. The primary hypothesis of this prospective, placebo-controlled, double-blind trial is that the increase of ejection fraction determined by magnetic resonance imaging between baseline and 6 months follow-up is superior in active treated patients compared to patients receiving placebo. The study includes an integrated pilot phase of 40 patients for evaluation of left ventricular ejection fraction determined by cardiac magnetic resonance imaging. Based on the data of this analysis the final sample size will be calculated. The primary endpoint is the improvement in left ventricular ejection fraction with an assumed 2.5% higher improvement in the cell treated population compared to the placebo treated group.
Detailed description
There is a 2:1 randomization for bone marrow cell therapy versus placebo therapy. Patients will be stratified according to age, localization of myocardial infarction and left ventricular function.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1 | Active comparator | Other: autologous stem cellsautologous stem cells, Ficoll preparation, intracoronary administration at the same day of bone marrow cell aspiration |
| 2 | Placebo comparator | Other: placebo suspensionplacebo is visually indistinguishable from verum due to integration of autologous erythrocytes, intracoronary administration the same day of bone marrow aspiration |
Who may qualify
- Ages
- 35 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- acute myocardial infarction with time to revascularization >6 hours from symptom start
- clear target vessel
- large myocardial infarction defined as: proximal vessel occlusion, CK > 1000 U/L, myocardial scar in magnetic resonance imaging > 10% of left ventricular muscle mass
- potential prior thrombolysis
- written informed consent
Key exclusion criteria (11 listed)
- acute myocardial infarction with revascularization within 6 hours after symptom start
- prior myocardial infarction
- no clear target vessel
- contraindication for magnetic resonance imaging (e.g. pacemaker, ICD)
- severely depressed left ventricular ejection fraction (less than 20% in magnetic resonance imaging)
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 |
|---|---|---|
| autologous stem cellsintracoronary administration at the same day of cell aspiration using the stop flow technique | Other | 1 |
| placebo suspensionintracoronary administration at the same day as cell aspiration | Other | 2 |
Primary outcome
difference in left ventricular ejection fraction measured by magnetic resonance imaging at baseline and 6 months follow-up
Time frame: 6 months
4 secondary outcomes
left ventricular ejection fraction measured by magnetic resonance imaging
Time frame: 1, 3, 12 months
left ventricular enddiastolic volume measured by magnetic resonance imaging
Time frame: 1, 3, 6, 12 months
left ventricular endsystolic volume measured by magnetic resonance imaging
Time frame: 1, 3, 6, 12 months
major adverse cardiac events
Time frame: 1, 3, 6, 12 months
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 10 Jun 2014.
- Background: PubMed 20211323Wohrle J, Merkle N, Mailander V, Nusser T, Schauwecker P, von Scheidt F, Schwarz K, Bommer M, Wiesneth M, Schrezenmeier H, Hombach V. Results of intracoronary stem cell therapy after acute myocardial infarction. Am J Cardiol. 2010 Mar 15;105(6):804-12. doi: 10.1016/j.amjcard.2009.10.060.
- Background: PubMed 23896972Wohrle J, von Scheidt F, Schauwecker P, Wiesneth M, Markovic S, Schrezenmeier H, Hombach V, Rottbauer W, Bernhardt P. Impact of cell number and microvascular obstruction in patients with bone-marrow derived cell therapy: final results from the randomized, double-blind, placebo controlled intracoronary Stem Cell therapy in patients with Acute Myocardial Infarction (SCAMI) trial. Clin Res Cardiol. 2013 Oct;102(10):765-70. doi: 10.1007/s00392-013-0595-9. Epub 2013 Jul 30.
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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.
Jochen Wöhrle, MD; FESC principal investigator
University of Ulm
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 autologous stem cells in people with Acute Myocardial Infarction and Coronary Artery Disease, run by University of Ulm at 1 site in Germany.
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 5 inclusion and 11 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 10 Jun 2014. 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 Germany. 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. Some participants in this study may receive a placebo. 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?
difference in left ventricular ejection fraction measured by magnetic resonance imaging at baseline and 6 months follow-up (time frame: 6 months). 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 NCT00669227, which also lists 2 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 10 Jun 2014.