Acute Myocardial Infarction, Heart Failure
Conditions
Keywords
Endocardial Stem Cells Injection, Percutaneous Coronary Intervention
Brief 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.
Interventions
PROCEDUREPCI and Stem Cells or Placebo injections
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.
Sponsors
Meshalkin Research Institute of Pathology of Circulation
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
30 Years to 75 Years
Healthy volunteers
No
Inclusion criteria
* 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
Exclusion criteria
* Thrombolysis of pyrrolase or streptokinase * Surgical unsignificant stenosis of LAD * Indications for CABG * Cardiogenic shock * Uncontrolled hypertension * Thrombocytopenia * 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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Reduction in left ventricle systolic volume on 15% mesured by MRI | 12 months |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| BNP level | 12 months | — |
| SPECT and Echo data | 12 months | — |
| number of heart failure hospitalizations | 12 months | — |
| number of patients with life-threatening arrhythmias | 12 months | — |
| All-cause death | 12 months | — |
| number of patients with thromboembolic events | 12 months | comparison the number of patients with thromboembolic events between two groups |
| Distance during 6-minute walking test | 12 months | — |
Countries
Russia
Contacts
Primary ContactEvgeny Pokushalov, MD
Backup ContactAlexander Romanov, MD
Outcome results
None listed