Acute Myocardial InfarctionPhase 3ESTIMATIONNCT01394432
"ESTIMATION Study" for Endocardial Mesenchymal Stem Cells Implantation in Patients After Acute Myocardial Infarction
A Phase 3 study of Acute Myocardial Infarction and Heart Failure, run by Meshalkin Research Institute of Pathology of Circulation at 1 site in Russia.
Trial summary
The investigators hypothesised that endocardial stem cells implantation following after percutaneous coronary intervention (PCI) could reduce the scar formation and increase reverse remodeling in patients with primary acute myocardial infarction. Read more about this study
- Who is it for?
- Ages 30 to 75 years
- Conditions the study is for
- Acute Myocardial Infarction, Heart Failure
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 50 participants
- Where
- 1 siteRussia
- Study dates
- Jul 2011to Nov 2016
- Phase
- Phase 3
- 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 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients with acute Q-wave myocardial infarction after thrombolitic therapy during 6-36 hours from the onsent of signs
- Oclusion or significant stenosis of infarct-related left anterior descending artery (LAD)
- Left ventricle ejection fraction (LVEF) < 50% measured by Echo
Who cannot join
- Thrombolysis of pyrrolase or streptokinase
- Surgical unsignificant stenosis of LAD
- Indications for CABG
- Cardiogenic shock
- Uncontrolled hypertension
- Thrombocytopenia
Show all 13Show fewer
- Ongoing bleeding
- Anemia < 100 g/l
- Oncology
- Patients, who required anticoagulation therapy at the time of inclusion
- Obesity, BMI>40
- Severe comorbidities
- Unwillingness to participate
Trial locations and contacts
1 site in 1 country.
Russia1 site, 1 recruiting
- Recruiting
State Research Institute of Circulation Pathology
Novosibirsk, 630055
Evgeny Pokushalov, MD, +79139254858, E.Pokushalov@gmail.com
Alexander Romanov, MD, +79137172652, abromanov@mail.ru
About this study
Official title: Endocardial Mesenchymal Stem Cells Implantation in Patients After Acute Myocardial Infarction
The investigators hypothesised that endocardial stem cells implantation following after percutaneous coronary intervention (PCI) could reduce the scar formation and increase reverse remodeling in patients with primary acute myocardial infarction.
- Conditions
- Acute Myocardial Infarction, Heart Failure
- Being tested
- PCI and Stem Cells or Placebo injections
- Keywords
- Endocardial Stem Cells Injection, Percutaneous Coronary Intervention
- Medical subject headings
- Heart Failure
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PCI and Stem Cells or Placebo injectionsProcedure or surgery
Conventional percutaneous coronary intervention after acute myocardial infarction. Harvest of bone marrow from iliac crest. Mesenchymal autologous stem cells preparation (7-10 days after PCI). LV mapping with Noga system (7-10 days after PCI). Randomization 1:1. Stem Cells or placebo implantation.
| Study group | Role | What they receive |
|---|---|---|
| Group 1 (PCI+SC implantation) | Active comparator | Endocardial Stem cells implantation with Noga system Receives: Procedure: PCI and Stem Cells or Placebo injections |
| Group 2 (PCI+Placebo) | Placebo comparator | Placebo Receives: Procedure: PCI and Stem Cells or Placebo injections |
What is being measured
The primary outcome is the main question the study is designed to answer.
Reduction in left ventricle systolic volume on 15% mesured by MRI
Measured: 12 months
Secondary outcomes (7)
All-cause death
Measured: 12 months
number of patients with thromboembolic events
comparison the number of patients with thromboembolic events between two groups
Measured: 12 months
number of heart failure hospitalizations
Measured: 12 months
Distance during 6-minute walking test
Measured: 12 months
number of patients with life-threatening arrhythmias
Measured: 12 months
BNP level
Measured: 12 months
SPECT and Echo data
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 posted14 Jul 2011 (estimated)
- Study startJul 2011
- Primary completionNov 2012
- Study completionNov 2016 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Meshalkin Research Institute of Pathology of Circulation
- Sponsor type
- Research network
- Responsible party
- Sponsor
- Investigators
- Evgeny A Pokushalov, MD, PhD, Principal investigator, State Research Institute of Circulation Pathology
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01394432
- Sponsor's protocol ID
- RBI-1749
- Other IDs
- RU8HM86-54N
- Acronym
- ESTIMATION
- Status last verified
- Sep 2015
- First submitted
- 8 Jul 2011
- Last updated
- 23 Sep 2015
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 23 Sep 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Endocardial Mesenchymal Stem Cells Implantation in Patients After Acute Myocardial Infarction
- ClinicalTrials.gov ID
- NCT01394432
- Acronym / sponsor ID
- ESTIMATION / RBI-1749
- Conditions
- Acute Myocardial Infarction, Heart Failure
- Keywords
- Endocardial Stem Cells Injection, Percutaneous Coronary Intervention
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- Meshalkin Research Institute of Pathology of CirculationResearch network
- Study start
- Jul 2011
- Primary completion
- Nov 2012 (actual)
- Study completion
- Nov 2016 (estimated)
- First posted
- 14 Jul 2011 (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 investigators hypothesised that endocardial stem cells implantation following after percutaneous coronary intervention (PCI) could reduce the scar formation and increase reverse remodeling in patients with primary acute myocardial infarction.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Group 1 (PCI+SC implantation) | Active comparator | Procedure: PCI and Stem Cells or Placebo injectionsEndocardial Stem cells implantation with Noga system |
| Group 2 (PCI+Placebo) | Placebo comparator | Procedure: PCI and Stem Cells or Placebo injectionsPlacebo |
Who may qualify
- Ages
- 30 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Patients with acute Q-wave myocardial infarction after thrombolitic therapy during 6-36 hours from the onsent of signs
- Oclusion or significant stenosis of infarct-related left anterior descending artery (LAD)
- Left ventricle ejection fraction (LVEF) < 50% measured by Echo
Key exclusion criteria (13 listed)
- Thrombolysis of pyrrolase or streptokinase
- Surgical unsignificant stenosis of LAD
- Indications for CABG
- Cardiogenic shock
- Uncontrolled hypertension
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 |
|---|---|---|
| PCI and Stem Cells or Placebo injectionsConventional percutaneous coronary intervention after acute myocardial infarction. Harvest of bone marrow from iliac crest. Mesenchymal autologous stem cells preparation (7-10 days after PCI). LV mapping with Noga system (7-10 days after PCI). Randomization 1:1. Stem Cells or placebo implantation. | Procedure or surgery | Group 1 (PCI+SC implantation), Group 2 (PCI+Placebo) |
Primary outcome
Reduction in left ventricle systolic volume on 15% mesured by MRI
Time frame: 12 months
7 secondary outcomes
All-cause death
Time frame: 12 months
number of patients with thromboembolic events
Time frame: 12 months
number of heart failure hospitalizations
Time frame: 12 months
Distance during 6-minute walking test
Time frame: 12 months
number of patients with life-threatening arrhythmias
Time frame: 12 months
BNP level
Time frame: 12 months
SPECT and Echo data
Time frame: 12 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Sep 2015.
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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.
Evgeny A Pokushalov, MD, PhD principal investigator
State Research Institute of Circulation Pathology
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study of Acute Myocardial Infarction and Heart Failure, run by Meshalkin Research Institute of Pathology of Circulation at 1 site in Russia.
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 13 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: status not confirmed, as of the sponsor's last update on 23 Sep 2015. 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 Russia. 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 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Evgeny Pokushalov, MD (+79139254858, E.Pokushalov@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Reduction in left ventricle systolic volume on 15% mesured by MRI (time frame: 12 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 23 Sep 2015; AzTrials last refreshed its copy on 4 Nov 2026.