Myocardial InfarctionPhase 2STEM-AMINCT00979758
Strengthening Transplantation Effects of Bone Marrow Mononuclear Cells With Atorvastatin in Myocardial Infarction
A Phase 2 study testing Atorvastatin and mononuclear cells transplantation in people with Myocardial Infarction and Stem Cell Transplantation, run by Chinese Academy of Medical Sciences, Fuwai Hospital at 1 site in China.
Trial summary
The benefit of current stem cell transplantation therapy for myocardial infarction is limited by low survival rate for stem cell. The purpose of this study is to test whether intensive Atorvastatin therapy can improve the outcome of patients with impaired left ventricle function after myocardial infarction who… Read more about this study
- Who is it for?
- Ages 30 to 80 years
- Conditions the study is for
- Myocardial Infarction, Stem Cell Transplantation, Angioplasty, Transluminal, Percutaneous Coronary
- What is being tested?
- Atorvastatin and mononuclear cells transplantation
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 100 participants
- Where
- 1 siteChina
- Study dates
- Jan 2009to Jun 2016
- 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 30 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients with coronary disease undergoing PCI.
- At most 2 months since last episode of ST-elevation myocardial infarction.
- Left ventricular ejection fraction >=20% <=45% based on coronary angiography or echocardiography.
Who cannot join
- Any one of the following exclusion criteria is sufficient to disqualify a patient from the study.
- Patients with non-ST-elevation myocardial infarction.
- Patients with normal left ventricular function.
- Patients with mechanical complications of myocardial infarction.
- Patients with a malignant tumor.
- Patients with infection disease.
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- Less than 6 months since last episode of stroke.
- Patients with hematological disease (leukemia, myeloproliferative disease, or myelodysplastic syndromes).
- AST (GOT) exceeding 100 IU/L or ALT (GPT) exceeding 100 IU/L.
- Leukocytes less than 4,000/µL or exceeding 10,000/µL.
- Platelets less than 100,000/µL.
- Hemoglobin less than 10 g/dL.
- Pregnant or nursing patients, those who may be pregnant, or those who plan on becoming pregnant before the end of the study period.
- Any other reason that the Clinical Supervisors or Clinical Researchers may have for considering a case unsuitable for the study.
Trial locations and contacts
1 site in 1 country.
About this study
The benefit of current stem cell transplantation therapy for myocardial infarction is limited by low survival rate for stem cell. The purpose of this study is to test whether intensive Atorvastatin therapy can improve the outcome of patients with impaired left ventricle function after myocardial infarction who underwent intracoronary transfer of autologous bone marrow cells.
Read the detailed description
The major challenge to a successful stem cell therapy for myocardial infarction is the low survival rate of implanted cells in the damaged tissue. Atorvastatin, an HMG-CoA reductase inhibitor, has multiple biological activities independent of cholesterol-lowering action.This study is performed to find out more information about the strategy with Atorvastatin therapy to improve the survival of implanted cells. autologous bone marrow stem cells transplantation. Patients between 30 and 80 years of age who receive autologous bone marrow stem cell transplant at the Fuwai cardiovascular hospital may be eligible for this study. These patients receive autologous bone marrow cells transplantation intracoronary undergoing Percutaneous Coronary Intervention with regular or high dose of Atorvastatin treatment. The objective evaluations will be performed at baseline and during 12 months follow-up.
Heart function tests may include the following:
- Electrocardiogram (EKG) evaluates the electrical activity of the heart. Electrodes placed on the chest transmit information from the heart to a machine.
- Echocardiogram (Echo) is an ultrasound test that uses sound waves to create an image of the heart and examine the function of the heart chambers and valves.
- Gated acquisition scan is a nuclear medicine test that uses a small amount of radioactive chemical injected into a vein. A special scanner creates an image of the heart for examining the beating motion of the muscle.
- MRI evaluates function of the heart chambers the beating motion of the muscle.
- Conditions
- Myocardial Infarction, Stem Cell Transplantation, Angioplasty, Transluminal, Percutaneous Coronary
- Being tested
- Atorvastatin and mononuclear cells transplantation
- Medical subject headings
- Myocardial Infarction
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Atorvastatin and mononuclear cells transplantationDrug
Also called Statin, Bone marrow stem cells transplantation
Routine or intensive dose of Atorvastatin therapy and mononuclear cells transplantation
| Study group | Role | What they receive |
|---|---|---|
| Atorvastatin | Sham comparator | Atorvastatin routine dose Receives: Drug: Atorvastatin and mononuclear cells transplantation |
| Intensive Atorvastatin | Placebo comparator | Atorvastatin Intensive dose Receives: Drug: Atorvastatin and mononuclear cells transplantation |
| Atorvastatin+Transplantation | Active comparator | Atorvastatin routine dose+ Mononuclear cells Transplantation Receives: Drug: Atorvastatin and mononuclear cells transplantation |
| Intensive Atorvastatin+Transplantation | Experimental | Atorvastatin intensive dose+ Mononuclear cells Transplantation Receives: Drug: Atorvastatin and mononuclear cells transplantation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Changes in left ventricular ejection fraction from baseline to 12 months' follow-up
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 posted18 Sep 2009 (estimated)
- Study startJan 2009
- Primary completionJun 2015
- Study completionJun 2016
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 Myocardial InfarctionStudies of the same condition, open and under way.
- More trials run by Chinese Academy of Medical Sciences, Fuwai 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
- Factorial
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 100 participants (actual)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Yuejin Yang, Chinese Academy of Medical Sciences, Fuwai Hospital
- Investigators
- Yang yuejin, Doctor, Study director, Chinese Academy of Medical Sciences, Fuwai Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00979758
- Sponsor's protocol ID
- Fuwai Hospital 2009
- Acronym
- STEM-AMI
- Status last verified
- Jan 2018
- First submitted
- 17 Sep 2009
- Last updated
- 25 Jan 2018
- Results posted
- No
- Data monitoring committee
- No
Publications
Yang YJ, Qian HY, Song L, Geng YJ, Gao RL, Li N, Wang H, Tian XQ, Huang J, Huang PS, Xu J, Shen R, Lu MJ, Zhao SH, Wu WC, Wu Y, Zhang J, Qian J, Xu JY, Xiong YY. Strengthening effects of bone marrow mononuclear cells with intensive atorvastatin in acute myocardial infarction. Open Heart. 2020 May;7(1):e001139. doi: 10.1136/openhrt-2019-001139.
PubMed 32393654
Study at a glance
From the registry record, last updated by the sponsor on 25 Jan 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Strengthening Transplantation Effects of Bone Marrow Mononuclear Cells With Atorvastatin in Myocardial Infarction
- ClinicalTrials.gov ID
- NCT00979758
- Acronym / sponsor ID
- STEM-AMI / Fuwai Hospital 2009
- Conditions
- Myocardial Infarction, Stem Cell Transplantation, Angioplasty, Transluminal, Percutaneous Coronary
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 100 participants (actual)
- Lead sponsor
- Chinese Academy of Medical Sciences, Fuwai HospitalUniversity, hospital or other
- Study start
- Jan 2009 (actual)
- Primary completion
- Jun 2015 (actual)
- Study completion
- Jun 2016 (actual)
- First posted
- 18 Sep 2009 (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 benefit of current stem cell transplantation therapy for myocardial infarction is limited by low survival rate for stem cell. The purpose of this study is to test whether intensive Atorvastatin therapy can improve the outcome of patients with impaired left ventricle function after myocardial infarction who underwent intracoronary transfer of autologous bone marrow cells.
Detailed description
The major challenge to a successful stem cell therapy for myocardial infarction is the low survival rate of implanted cells in the damaged tissue. Atorvastatin, an HMG-CoA reductase inhibitor, has multiple biological activities independent of cholesterol-lowering action.This study is performed to find out more information about the strategy with Atorvastatin therapy to improve the survival of implanted cells. autologous bone marrow stem cells transplantation. Patients between 30 and 80 years of age who receive autologous bone marrow stem cell transplant at the Fuwai cardiovascular hospital may be eligible for this study. These patients receive autologous bone marrow cells transplantation intracoronary undergoing Percutaneous Coronary Intervention with regular or high dose of Atorvastatin treatment. The objective evaluations will be performed at baseline and during 12 months follow-up.
Heart function tests may include the following:
- Electrocardiogram (EKG) evaluates the electrical activity of the heart. Electrodes placed on the chest transmit information from the heart to a machine.
- Echocardiogram (Echo) is an ultrasound test that uses sound waves to create an image of the heart and examine the function of the heart chambers and valves.
- Gated acquisition scan is a nuclear medicine test that uses a small amount of radioactive chemical injected into a vein. A special scanner creates an image of the heart for examining the beating motion of the muscle.
- MRI evaluates function of the heart chambers the beating motion of the muscle.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Atorvastatin | Sham comparator | Drug: Atorvastatin and mononuclear cells transplantationAtorvastatin routine dose |
| Intensive Atorvastatin | Placebo comparator | Drug: Atorvastatin and mononuclear cells transplantationAtorvastatin Intensive dose |
| Atorvastatin+Transplantation | Active comparator | Drug: Atorvastatin and mononuclear cells transplantationAtorvastatin routine dose+ Mononuclear cells Transplantation |
| Intensive Atorvastatin+Transplantation | Experimental | Drug: Atorvastatin and mononuclear cells transplantationAtorvastatin intensive dose+ Mononuclear cells Transplantation |
Who may qualify
- Ages
- 30 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Patients with coronary disease undergoing PCI.
- At most 2 months since last episode of ST-elevation myocardial infarction.
- Left ventricular ejection fraction >=20% <=45% based on coronary angiography or echocardiography.
Key exclusion criteria (14 listed)
- Any one of the following exclusion criteria is sufficient to disqualify a patient from the study.
- Patients with non-ST-elevation myocardial infarction.
- Patients with normal left ventricular function.
- Patients with mechanical complications of myocardial infarction.
- Patients with a malignant tumor.
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 |
|---|---|---|
| Atorvastatin and mononuclear cells transplantationAlso: Statin, Bone marrow stem cells transplantationRoutine or intensive dose of Atorvastatin therapy and mononuclear cells transplantation | Drug | Atorvastatin, Atorvastatin+Transplantation, Intensive Atorvastatin, Intensive Atorvastatin+Transplantation |
Primary outcome
Changes in left ventricular ejection fraction from baseline to 12 months' follow-up
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 25 Jan 2018.
- Derived from this study: PubMed 32393654Yang YJ, Qian HY, Song L, Geng YJ, Gao RL, Li N, Wang H, Tian XQ, Huang J, Huang PS, Xu J, Shen R, Lu MJ, Zhao SH, Wu WC, Wu Y, Zhang J, Qian J, Xu JY, Xiong YY. Strengthening effects of bone marrow mononuclear cells with intensive atorvastatin in acute myocardial infarction. Open Heart. 2020 May;7(1):e001139. doi: 10.1136/openhrt-2019-001139.
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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.
Yang yuejin, Doctor study director
Chinese Academy of Medical Sciences, Fuwai 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 Atorvastatin and mononuclear cells transplantation in people with Myocardial Infarction and Stem Cell Transplantation, run by Chinese Academy of Medical Sciences, Fuwai Hospital at 1 site in China.
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 14 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 25 Jan 2018. 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 China. 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?
Changes in left ventricular ejection fraction from baseline to 12 months' follow-up (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 NCT00979758, 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 25 Jan 2018; AzTrials last refreshed its copy on 8 Nov 2026.