Back to results"ESTIMATION Study" for Endocardial Mesenchymal Stem Cells Implantation in Patients After Acute Myocardial Infarction (ESTIMATION)
Primary Purpose
Acute Myocardial Infarction, Heart Failure
Status
Unknown status
Phase
Phase 3
Locations
Russian Federation
Study Type
Interventional
Intervention
PCI and Stem Cells or Placebo injections
Sponsored by
About this trial
This is an interventional treatment trial for Acute Myocardial Infarction focused on measuring Endocardial Stem Cells Injection, Percutaneous Coronary Intervention
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
- Oncology
- Patients, who required anticoagulation therapy at the time of inclusion
- Obesity, BMI>40
- Severe comorbidities
- Unwillingness to participate
Sites / Locations
- State Research Institute of Circulation PathologyRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Placebo Comparator
Arm Label
Group 1 (PCI+SC implantation)
Group 2 (PCI+Placebo)
Arm Description
Endocardial Stem cells implantation with Noga system
Placebo
Outcomes
Primary Outcome Measures
Reduction in left ventricle systolic volume on 15% mesured by MRI
Secondary Outcome Measures
All-cause death
number of patients with thromboembolic events
comparison the number of patients with thromboembolic events between two groups
number of heart failure hospitalizations
Distance during 6-minute walking test
number of patients with life-threatening arrhythmias
BNP level
SPECT and Echo data
Full Information
NCT ID
NCT01394432
First Posted
July 8, 2011
Last Updated
September 21, 2015
Sponsor
Meshalkin Research Institute of Pathology of Circulation
1. Study Identification
Unique Protocol Identification Number
NCT01394432
Brief Title
"ESTIMATION Study" for Endocardial Mesenchymal Stem Cells Implantation in Patients After Acute Myocardial Infarction
Acronym
ESTIMATION
Official Title
Endocardial Mesenchymal Stem Cells Implantation in Patients After Acute Myocardial Infarction
Study Type
Interventional
2. Study Status
Record Verification Date
September 2015
Overall Recruitment Status
Unknown status
Study Start Date
July 2011 (undefined)
Primary Completion Date
November 2012 (Actual)
Study Completion Date
November 2016 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Meshalkin Research Institute of Pathology of Circulation
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Acute Myocardial Infarction, Heart Failure
Keywords
Endocardial Stem Cells Injection, Percutaneous Coronary Intervention
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantOutcomes Assessor
Allocation
Randomized
Enrollment
50 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Group 1 (PCI+SC implantation)
Arm Type
Active Comparator
Arm Description
Endocardial Stem cells implantation with Noga system
Arm Title
Group 2 (PCI+Placebo)
Arm Type
Placebo Comparator
Arm Description
Placebo
Intervention Type
Procedure
Intervention Name(s)
PCI and Stem Cells or Placebo injections
Intervention Description
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 Measure Information:
Title
Reduction in left ventricle systolic volume on 15% mesured by MRI
Time Frame
12 months
Secondary Outcome Measure Information:
Title
All-cause death
Time Frame
12 months
Title
number of patients with thromboembolic events
Description
comparison the number of patients with thromboembolic events between two groups
Time Frame
12 months
Title
number of heart failure hospitalizations
Time Frame
12 months
Title
Distance during 6-minute walking test
Time Frame
12 months
Title
number of patients with life-threatening arrhythmias
Time Frame
12 months
Title
BNP level
Time Frame
12 months
Title
SPECT and Echo data
Time Frame
12 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
30 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
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
Oncology
Patients, who required anticoagulation therapy at the time of inclusion
Obesity, BMI>40
Severe comorbidities
Unwillingness to participate
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Evgeny Pokushalov, MD
Phone
+79139254858
Email
E.Pokushalov@gmail.com
First Name & Middle Initial & Last Name or Official Title & Degree
Alexander Romanov, MD
Phone
+79137172652
Email
abromanov@mail.ru
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Evgeny A Pokushalov, MD, PhD
Organizational Affiliation
State Research Institute of Circulation Pathology
Official's Role
Principal Investigator
Facility Information:
Facility Name
State Research Institute of Circulation Pathology
City
Novosibirsk
ZIP/Postal Code
630055
Country
Russian Federation
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Evgeny Pokushalov, MD
Phone
+79139254858
Email
E.Pokushalov@gmail.com
First Name & Middle Initial & Last Name & Degree
Alexander Romanov, MD
Phone
+79137172652
Email
abromanov@mail.ru
First Name & Middle Initial & Last Name & Degree
Evgeny Pokushalov, MD, PhD
First Name & Middle Initial & Last Name & Degree
Alexander Romanov, MD, PhD
First Name & Middle Initial & Last Name & Degree
Igor Grazhdankin, MD
12. IPD Sharing Statement
Learn more about this trial
"ESTIMATION Study" for Endocardial Mesenchymal Stem Cells Implantation in Patients After Acute Myocardial Infarction
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