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

The recruitment status of this study is unknown. The completion date has passed and the status has not been verified in more than two years.
Verified September 2015 by Meshalkin Research Institute of Pathology of Circulation.
Recruitment status was:  Recruiting
Sponsor:
Information provided by (Responsible Party):
Meshalkin Research Institute of Pathology of Circulation
ClinicalTrials.gov Identifier:
NCT01394432
First received: July 8, 2011
Last updated: September 21, 2015
Last verified: September 2015
  Purpose
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 Intervention Phase
Acute Myocardial Infarction Heart Failure Procedure: PCI and Stem Cells or Placebo injections Phase 3

Study Type: Interventional
Study Design: 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

Resource links provided by NLM:


Further study details as provided by Meshalkin Research Institute of Pathology of Circulation:

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

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

  • 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 ]

Estimated Enrollment: 50
Study Start Date: July 2011
Estimated Study Completion Date: November 2016
Primary Completion Date: November 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.

  Eligibility

Ages Eligible for Study:   30 Years to 75 Years   (Adult, Senior)
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: 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
  More Information

Additional Information:
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 )
Study First Received: July 8, 2011
Last Updated: September 21, 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

ClinicalTrials.gov processed this record on September 21, 2017