Ignite Creation Date:
2025-12-25 @ 5:08 AM
Ignite Modification Date:
2026-01-09 @ 11:46 PM
Study NCT ID:
NCT00669227
Status:
COMPLETED
Last Update Posted:
2014-06-10
First Post:
2008-04-28
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Intracoronary Stem Cell Therapy in Patients With Acute Myocardial Infarction (SCAMI)
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D003324', 'term': 'Coronary Artery Disease'}], 'ancestors': [{'id': 'D003327', 'term': 'Coronary Disease'}, {'id': 'D017202', 'term': 'Myocardial Ischemia'}, {'id': 'D006331', 'term': 'Heart Diseases'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}, {'id': 'D001161', 'term': 'Arteriosclerosis'}, {'id': 'D001157', 'term': 'Arterial Occlusive Diseases'}, {'id': 'D014652', 'term': 'Vascular Diseases'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 42}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2005-10'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2014-06', 'lastUpdateSubmitDate': '2014-06-07', 'studyFirstSubmitDate': '2008-04-28', 'studyFirstSubmitQcDate': '2008-04-29', 'lastUpdatePostDateStruct': {'date': '2014-06-10', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2008-04-30', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2009-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'difference in left ventricular ejection fraction measured by magnetic resonance imaging at baseline and 6 months follow-up', 'timeFrame': '6 months'}], 'secondaryOutcomes': [{'measure': 'left ventricular ejection fraction measured by magnetic resonance imaging', 'timeFrame': '1, 3, 12 months'}, {'measure': 'left ventricular enddiastolic volume measured by magnetic resonance imaging', 'timeFrame': '1, 3, 6, 12 months'}, {'measure': 'left ventricular endsystolic volume measured by magnetic resonance imaging', 'timeFrame': '1, 3, 6, 12 months'}, {'measure': 'major adverse cardiac events', 'timeFrame': '1, 3, 6, 12 months'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['Acute Myocardial Infarction', 'Coronary Artery Disease']}, 'referencesModule': {'references': [{'pmid': '20211323', 'type': 'BACKGROUND', 'citation': 'Wohrle J, Merkle N, Mailander V, Nusser T, Schauwecker P, von Scheidt F, Schwarz K, Bommer M, Wiesneth M, Schrezenmeier H, Hombach V. Results of intracoronary stem cell therapy after acute myocardial infarction. Am J Cardiol. 2010 Mar 15;105(6):804-12. doi: 10.1016/j.amjcard.2009.10.060.'}, {'pmid': '23896972', 'type': 'BACKGROUND', 'citation': 'Wohrle J, von Scheidt F, Schauwecker P, Wiesneth M, Markovic S, Schrezenmeier H, Hombach V, Rottbauer W, Bernhardt P. Impact of cell number and microvascular obstruction in patients with bone-marrow derived cell therapy: final results from the randomized, double-blind, placebo controlled intracoronary Stem Cell therapy in patients with Acute Myocardial Infarction (SCAMI) trial. Clin Res Cardiol. 2013 Oct;102(10):765-70. doi: 10.1007/s00392-013-0595-9. Epub 2013 Jul 30.'}]}, 'descriptionModule': {'briefSummary': 'Autologous stem cells may improve myocardial regeneration after intracoronary administration in patients with acute myocardial infarction. The primary hypothesis of this prospective, placebo-controlled, double-blind trial is that the increase of ejection fraction determined by magnetic resonance imaging between baseline and 6 months follow-up is superior in active treated patients compared to patients receiving placebo. The study includes an integrated pilot phase of 40 patients for evaluation of left ventricular ejection fraction determined by cardiac magnetic resonance imaging. Based on the data of this analysis the final sample size will be calculated. The primary endpoint is the improvement in left ventricular ejection fraction with an assumed 2.5% higher improvement in the cell treated population compared to the placebo treated group.', 'detailedDescription': 'There is a 2:1 randomization for bone marrow cell therapy versus placebo therapy. Patients will be stratified according to age, localization of myocardial infarction and left ventricular function.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '75 Years', 'minimumAge': '35 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* acute myocardial infarction with time to revascularization \\>6 hours from symptom start\n* clear target vessel\n* large myocardial infarction defined as: proximal vessel occlusion, CK \\> 1000 U/L, myocardial scar in magnetic resonance imaging \\> 10% of left ventricular muscle mass\n* potential prior thrombolysis\n* written informed consent\n\nExclusion Criteria:\n\n* acute myocardial infarction with revascularization within 6 hours after symptom start\n* prior myocardial infarction\n* no clear target vessel\n* contraindication for magnetic resonance imaging (e.g. pacemaker, ICD)\n* severely depressed left ventricular ejection fraction (less than 20% in magnetic resonance imaging)\n* prior hematologic disease\n* prior chemo therapy\n* prior stem cell transplantation\n* prior treatment with G-CSF\n* known alteration of the bone marrow by alcohol or drugs, e.g. agranulocytosis\n* local infection of puncture sites'}, 'identificationModule': {'nctId': 'NCT00669227', 'acronym': 'SCAMI', 'briefTitle': 'Intracoronary Stem Cell Therapy in Patients With Acute Myocardial Infarction (SCAMI)', 'organization': {'class': 'OTHER', 'fullName': 'University of Ulm'}, 'officialTitle': 'Intracoronary Stem Cell Therapy in Patients With Acute Myocardial Infarction - A Randomized, Double-blind, Placebo Controlled Trial (SCAMI)', 'orgStudyIdInfo': {'id': 'SCAMI 01-04'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': '1', 'description': 'autologous stem cells, Ficoll preparation, intracoronary administration at the same day of bone marrow cell aspiration', 'interventionNames': ['Other: autologous stem cells']}, {'type': 'PLACEBO_COMPARATOR', 'label': '2', 'description': 'placebo is visually indistinguishable from verum due to integration of autologous erythrocytes, intracoronary administration the same day of bone marrow aspiration', 'interventionNames': ['Other: placebo suspension']}], 'interventions': [{'name': 'autologous stem cells', 'type': 'OTHER', 'description': 'intracoronary administration at the same day of cell aspiration using the stop flow technique', 'armGroupLabels': ['1']}, {'name': 'placebo suspension', 'type': 'OTHER', 'description': 'intracoronary administration at the same day as cell aspiration', 'armGroupLabels': ['2']}]}, 'contactsLocationsModule': {'locations': [{'zip': '89081', 'city': 'Ulm', 'country': 'Germany', 'facility': 'University of Ulm', 'geoPoint': {'lat': 48.39841, 'lon': 9.99155}}], 'overallOfficials': [{'name': 'Jochen Wöhrle, MD; FESC', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of Ulm'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Ulm', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Prof. Dr. Jochen Wöhrle', 'investigatorFullName': 'Jochen Wohrle', 'investigatorAffiliation': 'University of Ulm'}}}}