Ischemic Heart DiseaseACCRUENCT01098591
Meta-Analysis of Cell-based CaRdiac stUdiEs: ACCRUE
An observational study of Ischemic Heart Disease, run by Medical University of Vienna at 1 site in Austria.
Trial summary
Numerous human cardiac stem cell studies have been published, including relatively small number of patients. Meta-analysis of randomized trials have reported safety and a 3-6% increase in global left ventricular performance after intracoronary stem cell therapy in patients with acute myocardial infarction. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Ischemic Heart Disease
- What is being tested?
- cell therapy
- How many people
- 3,500 participants
- Where
- 1 siteAustria
- Study dates
- Nov 2007to Dec 2020
- Phase
- Observational
- 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 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients treated with cell-based cardiac therapy at one of the participating centers
Who may be able to join
- patient included in one of the registered cell-based cardiac therapy of the participating center
Who cannot join
- none
Trial locations and contacts
1 site in 1 country.
About this study
Numerous human cardiac stem cell studies have been published, including relatively small number of patients. Meta-analysis of randomized trials have reported safety and a 3-6% increase in global left ventricular performance after intracoronary stem cell therapy in patients with acute myocardial infarction. Since most of the studies used different type of stem cells, delivery modes, and patient population, the results are heterogenous, therefore the comparison of the results is biased regarding generalizable conclusions about the effect of treatment. The present comparative meta-analysis is based on individual patient data, and gathers and pools the raw data, and analyzes the clinical outcome, safety and efficacy of the cardiac stem cell therapy.
Read the detailed description
- Background: Many clinical trials and meta-analyses presented moderate but significant improvement of the left ventricular ejection fraction (LVEF) after intracoronary autologous bone-marrow (BM) or peripheral blood origin stem cells transfer. However, it remains controversial, whether this beneficial effects is comparable with the intramyocardial delivery of the stem cells, or could be maintained during moderate and long term follow-up. The BOOST trial suggested that cardiac stem cell therapy did not improve LVEF at 5-year follow-up. By contrast, BALANCE study showed a long sustained benefit of BM-stem cells treatment. Due to these divergent outcomes of the presented trials, the aim of the present meta-analysis is to compare the safety and effectiveness of the cardiac stem cell therapy in different patient population, delivery mode and cell type, to find out, which patients with which therapy mode can have the greatest benefit from cardiac stem cell therapy.
- Study design: individual patient data meta-analysis
- Data sources: European Centre performing human cardiac stem cell therapy have been contacted calling for participation.
- Methods: Individual data gathering and entering into the database for a pooled analysis. The meta-analysis will be done in line with recommendation from the Cochrane Collaboration and the Quality of Reporting of Meta-analyses guidelines with Review Manager 5.0. Fixed-effect model will be used.
- Conditions
- Ischemic Heart Disease
- Being tested
- cell therapy
- Keywords
- meta-analysis, stem cell, cardiac, remodeling, ACCRUE
- Medical subject headings
- Myocardial Ischemia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
cell therapyOther
| Study group | Role | What they receive |
|---|---|---|
| Myocardial infarction | Patients with post-myocardial infarction receiving cell therapy either intracoronarily or intramyocardial Receives: Other: cell therapy | |
| Ischemic cardiomyopathy | Patients with ischemic cardiomyopathy treated with cell therapy either intracoronarily or intramyocardial Receives: Other: cell therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Freedom from occurrence of major adverse cardiac and cerebrovascular events (MACCE), including all-cause death, re-infarction, revascularization and stroke
MACCE is defined as all-cause death, re-infarction, revascularization and stroke
Measured: 12 months
Secondary outcomes (4)
Hard clinical end point
all-cause death, re-infarction and stroke
Measured: 12 months
Changes in end-diastolic volume
End-diastolic volume is an index of ventricular remodeling
Measured: 12 months
Changes in end-systolic volume
Index of ventricular systolic performance
Measured: 12 months
Changes in ejection fraction
Improvement of systolic cardiac function after cell therapy
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Apr 2010 (estimated)
- Study startNov 2007
- Primary completionDec 2020
- Study completionDec 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Ischemic Heart DiseaseStudies of the same condition, open and under way.
- More trials run by Medical University of ViennaThe 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
- Observational
- Observational model
- Case only
- Time perspective
- Retrospective
- Enrolment
- 3,500 participants (actual)
Sponsor and investigators
- Lead sponsor
- Medical University of Vienna
- Sponsor type
- University, hospital or other
- Collaborators
- Nantes University Hospital, Oslo University Hospital, Medical University of Silesia, Hannover Medical School, VZW Cardiovascular Research Center Aalst, Cedars-Sinai Medical Center, Johann Wolfgang Goethe University Hospital, University of Ulm, Military Medical Academy, Belgrade, Serbia, Novosibirsk Scientific Research Institute for Circulatory Pathology, Copenhagen University Hospital, Rigshospitalet, Asklepios Kliniken Hamburg GmbH, Leiden University Medical Center, University of Debrecen, University of Targu Mures, Romania, University Clinic for Cardiology, Skopje, Republic of Macedonia, State Health Center, Hungary, Karolinska Institutet, University of Zurich, University of Oulu, Odense University Hospital, Minneapolis Heart Institute, The University of Texas Health Science Center, Houston, Klinik Hirslanden, Zurich, University Hospital, Toulouse, Heinrich-Heine University, Duesseldorf
- Responsible party
- Principal investigator, Mariann Gyongyosi, Medical University of Vienna
- Investigators
- Mariann Gyongyosi, MD, Principal investigator, Medical University of Vienna
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01098591
- Sponsor's protocol ID
- MUW - Meta
- Acronym
- ACCRUE
- Status last verified
- Jul 2021
- First submitted
- 30 Mar 2010
- Last updated
- 13 Jul 2021
- Results posted
- No
- Data monitoring committee
- No
Publications
Gyongyosi M, Wojakowski W, Lemarchand P, Lunde K, Tendera M, Bartunek J, Marban E, Assmus B, Henry TD, Traverse JH, Moye LA, Surder D, Corti R, Huikuri H, Miettinen J, Wohrle J, Obradovic S, Roncalli J, Malliaras K, Pokushalov E, Romanov A, Kastrup J, Bergmann MW, Atsma DE, Diederichsen A, Edes I, Benedek I, Benedek T, Pejkov H, Nyolczas N, Pavo N, Bergler-Klein J, Pavo IJ, Sylven C, Berti S, Navarese EP, Maurer G; ACCRUE Investigators. Meta-Analysis of Cell-based CaRdiac stUdiEs (ACCRUE) in patients with acute myocardial infarction based on individual patient data. Circ Res. 2015 Apr 10;116(8):1346-60. doi: 10.1161/CIRCRESAHA.116.304346. Epub 2015 Feb 19.
PubMed 25700037
Study at a glance
From the registry record, last updated by the sponsor on 13 Jul 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Meta-Analysis of Cell-based CaRdiac stUdiEs: ACCRUE
- ClinicalTrials.gov ID
- NCT01098591
- Acronym / sponsor ID
- ACCRUE / MUW - Meta
- Conditions
- Ischemic Heart Disease
- Keywords
- meta-analysis, stem cell, cardiac, remodeling, ACCRUE
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 3,500 participants (actual)
- Lead sponsor
- Medical University of ViennaUniversity, hospital or other
- Collaborators
- Nantes University Hospital, Oslo University Hospital, Medical University of Silesia, Hannover Medical School, VZW Cardiovascular Research Center Aalst, Cedars-Sinai Medical Center, Johann Wolfgang Goethe University Hospital, University of Ulm, Military Medical Academy, Belgrade, Serbia, Novosibirsk Scientific Research Institute for Circulatory Pathology, Copenhagen University Hospital, Rigshospitalet, Asklepios Kliniken Hamburg GmbH, Leiden University Medical Center, University of Debrecen, University of Targu Mures, Romania, University Clinic for Cardiology, Skopje, Republic of Macedonia, State Health Center, Hungary, Karolinska Institutet, University of Zurich, University of Oulu, Odense University Hospital, Minneapolis Heart Institute, The University of Texas Health Science Center, Houston, Klinik Hirslanden, Zurich, University Hospital, Toulouse, Heinrich-Heine University, Duesseldorf
- Study start
- Nov 2007 (actual)
- Primary completion
- Dec 2020 (actual)
- Study completion
- Dec 2020 (actual)
- First posted
- 5 Apr 2010 (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.
Numerous human cardiac stem cell studies have been published, including relatively small number of patients. Meta-analysis of randomized trials have reported safety and a 3-6% increase in global left ventricular performance after intracoronary stem cell therapy in patients with acute myocardial infarction. Since most of the studies used different type of stem cells, delivery modes, and patient population, the results are heterogenous, therefore the comparison of the results is biased regarding generalizable conclusions about the effect of treatment. The present comparative meta-analysis is based on individual patient data, and gathers and pools the raw data, and analyzes the clinical outcome, safety and efficacy of the cardiac stem cell therapy.
Detailed description
- Background: Many clinical trials and meta-analyses presented moderate but significant improvement of the left ventricular ejection fraction (LVEF) after intracoronary autologous bone-marrow (BM) or peripheral blood origin stem cells transfer. However, it remains controversial, whether this beneficial effects is comparable with the intramyocardial delivery of the stem cells, or could be maintained during moderate and long term follow-up. The BOOST trial suggested that cardiac stem cell therapy did not improve LVEF at 5-year follow-up. By contrast, BALANCE study showed a long sustained benefit of BM-stem cells treatment. Due to these divergent outcomes of the presented trials, the aim of the present meta-analysis is to compare the safety and effectiveness of the cardiac stem cell therapy in different patient population, delivery mode and cell type, to find out, which patients with which therapy mode can have the greatest benefit from cardiac stem cell therapy.
- Study design: individual patient data meta-analysis
- Data sources: European Centre performing human cardiac stem cell therapy have been contacted calling for participation.
- Methods: Individual data gathering and entering into the database for a pooled analysis. The meta-analysis will be done in line with recommendation from the Cochrane Collaboration and the Quality of Reporting of Meta-analyses guidelines with Review Manager 5.0. Fixed-effect model will be used.
Study design
- Observational model
- Case only
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Myocardial infarction | – | Other: cell therapyPatients with post-myocardial infarction receiving cell therapy either intracoronarily or intramyocardial |
| Ischemic cardiomyopathy | – | Other: cell therapyPatients with ischemic cardiomyopathy treated with cell therapy either intracoronarily or intramyocardial |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients treated with cell-based cardiac therapy at one of the participating centers
Key inclusion criteria (1 listed)
- patient included in one of the registered cell-based cardiac therapy of the participating center
Key exclusion criteria (1 listed)
- none
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 |
|---|---|---|
| cell therapy | Other | Ischemic cardiomyopathy, Myocardial infarction |
Primary outcome
Freedom from occurrence of major adverse cardiac and cerebrovascular events (MACCE), including all-cause death, re-infarction, revascularization and stroke
Time frame: 12 months
MACCE is defined as all-cause death, re-infarction, revascularization and stroke
4 secondary outcomes
Hard clinical end point
Time frame: 12 months
Changes in end-diastolic volume
Time frame: 12 months
Changes in end-systolic volume
Time frame: 12 months
Changes in ejection fraction
Time frame: 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 13 Jul 2021.
- Derived from this study: PubMed 25700037Gyongyosi M, Wojakowski W, Lemarchand P, Lunde K, Tendera M, Bartunek J, Marban E, Assmus B, Henry TD, Traverse JH, Moye LA, Surder D, Corti R, Huikuri H, Miettinen J, Wohrle J, Obradovic S, Roncalli J, Malliaras K, Pokushalov E, Romanov A, Kastrup J, Bergmann MW, Atsma DE, Diederichsen A, Edes I, Benedek I, Benedek T, Pejkov H, Nyolczas N, Pavo N, Bergler-Klein J, Pavo IJ, Sylven C, Berti S, Navarese EP, Maurer G; ACCRUE Investigators. Meta-Analysis of Cell-based CaRdiac stUdiEs (ACCRUE) in patients with acute myocardial infarction based on individual patient data. Circ Res. 2015 Apr 10;116(8):1346-60. doi: 10.1161/CIRCRESAHA.116.304346. Epub 2015 Feb 19.
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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.
Mariann Gyongyosi, MD principal investigator
Medical University of Vienna
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Ischemic Heart Disease, run by Medical University of Vienna at 1 site in Austria.
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 13 Jul 2021. 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 Austria. 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.
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?
Freedom from occurrence of major adverse cardiac and cerebrovascular events (MACCE), including all-cause death, re-infarction, revascularization and stroke (time frame: 12 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 NCT01098591, which also lists 1 linked publication.
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 13 Jul 2021.