Ignite Creation Date:
2025-12-24 @ 10:58 PM
Ignite Modification Date:
2025-12-29 @ 8:17 AM
Study NCT ID:
NCT00755469
Status:
COMPLETED
Last Update Posted:
2013-12-05
First Post:
2008-09-18
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Post-conditioning to Reduce Infarct Size
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24', 'submissionTracking': {'submissionInfos': [{'resetDate': '2019-08-09', 'releaseDate': '2019-07-01'}, {'resetDate': '2019-10-03', 'releaseDate': '2019-09-11'}], 'estimatedResultsFirstSubmitDate': '2019-07-01'}}, 'conditionBrowseModule': {'meshes': [{'id': 'D009203', 'term': 'Myocardial Infarction'}, {'id': 'D015427', 'term': 'Reperfusion Injury'}], 'ancestors': [{'id': 'D017202', 'term': 'Myocardial Ischemia'}, {'id': 'D006331', 'term': 'Heart Diseases'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}, {'id': 'D014652', 'term': 'Vascular Diseases'}, {'id': 'D007238', 'term': 'Infarction'}, {'id': 'D007511', 'term': 'Ischemia'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'id': 'D009336', 'term': 'Necrosis'}, {'id': 'D011183', 'term': 'Postoperative Complications'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D057775', 'term': 'Ischemic Postconditioning'}], 'ancestors': [{'id': 'D013812', 'term': 'Therapeutics'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['PARTICIPANT']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 43}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2008-09'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2013-12', 'completionDateStruct': {'date': '2010-08', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2013-12-03', 'studyFirstSubmitDate': '2008-09-18', 'studyFirstSubmitQcDate': '2008-09-18', 'lastUpdatePostDateStruct': {'date': '2013-12-05', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2008-09-19', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2010-08', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Infarct size, determined by late-enhancement measurements of the LV using gadolinium contrast with cardiac MRI', 'timeFrame': '3 months'}], 'secondaryOutcomes': [{'measure': 'The degree of Microvascular Obstruction (MVO), as measured by Cardiac MRI', 'timeFrame': '3 months'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Reperfusion injury', 'Post-Conditioning', 'Infarct size'], 'conditions': ['Myocardial Infarction']}, 'referencesModule': {'references': [{'type': 'BACKGROUND', 'citation': 'Traverse JH, Wang YL, Chavez, IJ, Lesser JR, Pedersen WR, Mirheydar H, Henry TD. Post Conditioning reduces infarct size and improves LV function during acute myocardial infarction. Circulation 2006;114:II-344.'}, {'pmid': '16186417', 'type': 'BACKGROUND', 'citation': "Staat P, Rioufol G, Piot C, Cottin Y, Cung TT, L'Huillier I, Aupetit JF, Bonnefoy E, Finet G, Andre-Fouet X, Ovize M. Postconditioning the human heart. Circulation. 2005 Oct 4;112(14):2143-8. doi: 10.1161/CIRCULATIONAHA.105.558122. Epub 2005 Sep 26."}, {'pmid': '21136310', 'type': 'RESULT', 'citation': 'Garcia S, Henry TD, Wang YL, Chavez IJ, Pedersen WR, Lesser JR, Shroff GR, Moore L, Traverse JH. Long-term follow-up of patients undergoing postconditioning during ST-elevation myocardial infarction. J Cardiovasc Transl Res. 2011 Feb;4(1):92-8. doi: 10.1007/s12265-010-9252-0. Epub 2010 Dec 7.'}], 'seeAlsoLinks': [{'url': 'http://www.mplsheart.org', 'label': 'The Minneapolis Heart Institute Foundation improves cardiovascular health through clinical research and education'}]}, 'descriptionModule': {'briefSummary': 'When angioplasty (PTCA) and stenting of the blood vessels of the heart is the treatment for a Heart Attack, there is damage to the heart muscle that is caused by the sudden opening of the blood vessels. This is called "reperfusion injury". The cell death is due to inflammation and the generation of free radicals.\n\nThe primary objective of this study is to determine if post-conditioning(four brief (30 second) PTCA balloon inflations) reduces damage to the heart muscle. This will be measured by heart enzyme tests-CK measurements- and by cardiac MRI.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '80 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Age ≥ 18 \\< 80\n* Able to give informed consent\n* 100% occlusion of a major epicardial vessel with TIMI 0 Flow\n\nExclusion Criteria:\n\n* Significant collateral blood flow to the distal vasculature of the occluded vessel.\n* Previous CABG\n* Previous q-wave myocardial infarction in the same territory'}, 'identificationModule': {'nctId': 'NCT00755469', 'briefTitle': 'Post-conditioning to Reduce Infarct Size', 'organization': {'class': 'OTHER', 'fullName': 'Minneapolis Heart Institute Foundation'}, 'officialTitle': 'Modification of Reperfusion by "Post-Conditioning" Reduces Infarct Size in Acute Myocardial Infarction', 'orgStudyIdInfo': {'id': 'opt002'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': '1', 'interventionNames': ['Procedure: Post-conditioning']}], 'interventions': [{'name': 'Post-conditioning', 'type': 'PROCEDURE', 'description': 'The post-conditioning protocol consists of performing 4, 30-second PTCA balloon occlusions followed by 30 seconds of reperfusion for a total of 4 minutes. The first balloon inflation occurs immediately after an angioplasty guidewire is placed through the obstruction in the artery and flow is restored. Following this protocol the vessel will be stented as part of usual practice for treatment of acute MI.', 'armGroupLabels': ['1']}]}, 'contactsLocationsModule': {'locations': [{'zip': '55407', 'city': 'Minneapolis', 'state': 'Minnesota', 'country': 'United States', 'facility': 'Abbott Northwestern Hospital', 'geoPoint': {'lat': 44.97997, 'lon': -93.26384}}], 'overallOfficials': [{'name': 'Jay H Traverse, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Minneapolis Heart Institute at Abbott Northwestern Hospital'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Minneapolis Heart Institute Foundation', 'class': 'OTHER'}, 'collaborators': [{'name': 'Society for Cardiovascular Angiography and Interventions', 'class': 'OTHER'}], 'responsibleParty': {'type': 'SPONSOR'}}}, 'annotationSection': {'annotationModule': {'unpostedAnnotation': {'unpostedEvents': [{'date': '2019-07-01', 'type': 'RELEASE'}, {'date': '2019-08-09', 'type': 'RESET'}, {'date': '2019-09-11', 'type': 'RELEASE'}, {'date': '2019-10-03', 'type': 'RESET'}], 'unpostedResponsibleParty': 'Minneapolis Heart Institute Foundation'}}}}