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"ESTIMATION Study" for Endocardial Mesenchymal Stem Cells Implantation in Patients After Acute Myocardial Infarction (ESTIMATION)

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ClinicalTrials.gov Identifier: NCT01394432
Recruitment Status : Unknown
Verified September 2015 by Meshalkin Research Institute of Pathology of Circulation.
Recruitment status was:  Recruiting
First Posted : July 14, 2011
Last Update Posted : September 23, 2015
Sponsor:
Information provided by (Responsible Party):
Meshalkin Research Institute of Pathology of Circulation

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.

Condition or disease Intervention/treatment Phase
Acute Myocardial Infarction Heart Failure Procedure: PCI and Stem Cells or Placebo injections Phase 3

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 50 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Endocardial Mesenchymal Stem Cells Implantation in Patients After Acute Myocardial Infarction
Study Start Date : July 2011
Actual Primary Completion Date : November 2012
Estimated Study Completion Date : November 2016

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Heart Attack

Arm Intervention/treatment
Active Comparator: Group 1 (PCI+SC implantation)
Endocardial Stem cells implantation with Noga system
Procedure: PCI 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.

Placebo Comparator: Group 2 (PCI+Placebo)
Placebo
Procedure: PCI 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.




Primary Outcome Measures :
  1. Reduction in left ventricle systolic volume on 15% mesured by MRI [ Time Frame: 12 months ]

Secondary Outcome Measures :
  1. All-cause death [ Time Frame: 12 months ]
  2. number of patients with thromboembolic events [ Time Frame: 12 months ]
    comparison the number of patients with thromboembolic events between two groups

  3. number of heart failure hospitalizations [ Time Frame: 12 months ]
  4. Distance during 6-minute walking test [ Time Frame: 12 months ]
  5. number of patients with life-threatening arrhythmias [ Time Frame: 12 months ]
  6. BNP level [ Time Frame: 12 months ]
  7. SPECT and Echo data [ Time Frame: 12 months ]


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Ages Eligible for Study:   30 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01394432


Contacts
Contact: Evgeny Pokushalov, MD +79139254858 E.Pokushalov@gmail.com
Contact: Alexander Romanov, MD +79137172652 abromanov@mail.ru

Locations
Russian Federation
State Research Institute of Circulation Pathology Recruiting
Novosibirsk, Russian Federation, 630055
Contact: Evgeny Pokushalov, MD    +79139254858    E.Pokushalov@gmail.com   
Contact: Alexander Romanov, MD    +79137172652    abromanov@mail.ru   
Principal Investigator: Evgeny Pokushalov, MD, PhD         
Sub-Investigator: Alexander Romanov, MD, PhD         
Sub-Investigator: Igor Grazhdankin, MD         
Sponsors and Collaborators
Meshalkin Research Institute of Pathology of Circulation
Investigators
Principal Investigator: Evgeny A Pokushalov, MD, PhD State Research Institute of Circulation Pathology

Responsible Party: Meshalkin Research Institute of Pathology of Circulation
ClinicalTrials.gov Identifier: NCT01394432     History of Changes
Other Study ID Numbers: RBI-1749
RU8HM86-54N ( Other Identifier: State Research Institute of Circulation Pathology )
First Posted: July 14, 2011    Key Record Dates
Last Update Posted: September 23, 2015
Last Verified: September 2015

Keywords provided by Meshalkin Research Institute of Pathology of Circulation:
Endocardial Stem Cells Injection
Percutaneous Coronary Intervention

Additional relevant MeSH terms:
Heart Failure
Infarction
Myocardial Infarction
Heart Diseases
Cardiovascular Diseases
Ischemia
Pathologic Processes
Necrosis
Myocardial Ischemia
Vascular Diseases