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Clinical Trials/NCT01394432
NCT01394432
Unknown
Phase 3

Endocardial Mesenchymal Stem Cells Implantation in Patients After Acute Myocardial Infarction

Meshalkin Research Institute of Pathology of Circulation1 site in 1 country50 target enrollmentJuly 2011
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ConditionsAcute Myocardial InfarctionHeart Failure

Overview

Phase
Phase 3
Intervention
Not specified
Conditions
Acute Myocardial Infarction
Sponsor
Meshalkin Research Institute of Pathology of Circulation
Enrollment
50
Locations
1
Primary Endpoint
Reduction in left ventricle systolic volume on 15% mesured by MRI
Last Updated
10 years ago
OverviewInvestigatorsEligibility CriteriaOutcomesSitesSimilar Trials

Overview

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.

Registry
clinicaltrials.gov
Start Date
July 2011
End Date
November 2016
Last Updated
10 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Sponsor
Meshalkin Research Institute of Pathology of Circulation
Responsible Party
Sponsor

Eligibility 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
  • •Patients, who required anticoagulation therapy at the time of inclusion
  • •Obesity, BMI\>40

Outcomes

Primary Outcomes

Reduction in left ventricle systolic volume on 15% mesured by MRI

Time Frame: 12 months

Secondary Outcomes

  • number of patients with life-threatening arrhythmias(12 months)
  • SPECT and Echo data(12 months)
  • number of patients with thromboembolic events(12 months)
  • number of heart failure hospitalizations(12 months)
  • BNP level(12 months)
  • All-cause death(12 months)
  • Distance during 6-minute walking test(12 months)

Study Sites (1)

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