Ignite Creation Date:
2025-12-24 @ 9:57 PM
Ignite Modification Date:
2026-01-02 @ 6:48 AM
Study NCT ID:
NCT01394432
Status:
UNKNOWN
Last Update Posted:
2015-09-23
First Post:
2011-07-08
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
"ESTIMATION Study" for Endocardial Mesenchymal Stem Cells Implantation in Patients After Acute Myocardial Infarction
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D006333', 'term': 'Heart Failure'}], 'ancestors': [{'id': 'D006331', 'term': 'Heart Diseases'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 50}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2011-07'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2015-09', 'completionDateStruct': {'date': '2016-11', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2015-09-21', 'studyFirstSubmitDate': '2011-07-08', 'studyFirstSubmitQcDate': '2011-07-13', 'lastUpdatePostDateStruct': {'date': '2015-09-23', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2011-07-14', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2012-11', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Reduction in left ventricle systolic volume on 15% mesured by MRI', 'timeFrame': '12 months'}], 'secondaryOutcomes': [{'measure': 'All-cause death', 'timeFrame': '12 months'}, {'measure': 'number of patients with thromboembolic events', 'timeFrame': '12 months', 'description': 'comparison the number of patients with thromboembolic events between two groups'}, {'measure': 'number of heart failure hospitalizations', 'timeFrame': '12 months'}, {'measure': 'Distance during 6-minute walking test', 'timeFrame': '12 months'}, {'measure': 'number of patients with life-threatening arrhythmias', 'timeFrame': '12 months'}, {'measure': 'BNP level', 'timeFrame': '12 months'}, {'measure': 'SPECT and Echo data', 'timeFrame': '12 months'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['Endocardial Stem Cells Injection', 'Percutaneous Coronary Intervention'], 'conditions': ['Acute Myocardial Infarction', 'Heart Failure']}, 'descriptionModule': {'briefSummary': '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.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '75 Years', 'minimumAge': '30 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patients with acute Q-wave myocardial infarction after thrombolitic therapy during 6-36 hours from the onsent of signs\n* Oclusion or significant stenosis of infarct-related left anterior descending artery (LAD)\n* Left ventricle ejection fraction (LVEF) \\< 50% measured by Echo\n\nExclusion Criteria:\n\n* Thrombolysis of pyrrolase or streptokinase\n* Surgical unsignificant stenosis of LAD\n* Indications for CABG\n* Cardiogenic shock\n* Uncontrolled hypertension\n* Thrombocytopenia\n* Ongoing bleeding\n* Anemia \\< 100 g/l\n* Oncology\n* Patients, who required anticoagulation therapy at the time of inclusion\n* Obesity, BMI\\>40\n* Severe comorbidities\n* Unwillingness to participate'}, 'identificationModule': {'nctId': 'NCT01394432', 'acronym': 'ESTIMATION', 'briefTitle': '"ESTIMATION Study" for Endocardial Mesenchymal Stem Cells Implantation in Patients After Acute Myocardial Infarction', 'organization': {'class': 'NETWORK', 'fullName': 'Meshalkin Research Institute of Pathology of Circulation'}, 'officialTitle': 'Endocardial Mesenchymal Stem Cells Implantation in Patients After Acute Myocardial Infarction', 'orgStudyIdInfo': {'id': 'RBI-1749'}, 'secondaryIdInfos': [{'id': 'RU8HM86-54N', 'type': 'OTHER', 'domain': 'State Research Institute of Circulation Pathology'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Group 1 (PCI+SC implantation)', 'description': 'Endocardial Stem cells implantation with Noga system', 'interventionNames': ['Procedure: PCI and Stem Cells or Placebo injections']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Group 2 (PCI+Placebo)', 'description': 'Placebo', 'interventionNames': ['Procedure: PCI and Stem Cells or Placebo injections']}], 'interventions': [{'name': 'PCI and Stem Cells or Placebo injections', 'type': 'PROCEDURE', '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.', 'armGroupLabels': ['Group 1 (PCI+SC implantation)', 'Group 2 (PCI+Placebo)']}]}, 'contactsLocationsModule': {'locations': [{'zip': '630055', 'city': 'Novosibirsk', 'status': 'RECRUITING', 'country': 'Russia', 'contacts': [{'name': 'Evgeny Pokushalov, MD', 'role': 'CONTACT', 'email': 'E.Pokushalov@gmail.com', 'phone': '+79139254858'}, {'name': 'Alexander Romanov, MD', 'role': 'CONTACT', 'email': 'abromanov@mail.ru', 'phone': '+79137172652'}, {'name': 'Evgeny Pokushalov, MD, PhD', 'role': 'PRINCIPAL_INVESTIGATOR'}, {'name': 'Alexander Romanov, MD, PhD', 'role': 'SUB_INVESTIGATOR'}, {'name': 'Igor Grazhdankin, MD', 'role': 'SUB_INVESTIGATOR'}], 'facility': 'State Research Institute of Circulation Pathology', 'geoPoint': {'lat': 55.02259, 'lon': 82.93175}}], 'centralContacts': [{'name': 'Evgeny Pokushalov, MD', 'role': 'CONTACT', 'email': 'E.Pokushalov@gmail.com', 'phone': '+79139254858'}, {'name': 'Alexander Romanov, MD', 'role': 'CONTACT', 'email': 'abromanov@mail.ru', 'phone': '+79137172652'}], 'overallOfficials': [{'name': 'Evgeny A Pokushalov, MD, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'State Research Institute of Circulation Pathology'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Meshalkin Research Institute of Pathology of Circulation', 'class': 'NETWORK'}, 'responsibleParty': {'type': 'SPONSOR'}}}}